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Lurasidone

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Lurasidone
Ball-and-stick model of the lurasidone molecule
Clinical data
Pronunciation/ljʊəˈræsɪˌdoʊn/
Trade namesLatuda, others
Other namesSM-13496
AHFS/Drugs.comMonograph
MedlinePlusa611016
License data
Pregnancy
category
Routes of
administration		By mouth
Drug classAtypical antipsychotic[2]
ATC code
Legal status
Legal status
Pharmacokinetic data
Bioavailability9–19% (oral)[3]
Protein binding~99%[9]
MetabolismLiver (CYP3A4-mediated)[3]
Elimination half-life18–40 hours[3][9]
ExcretionFaecal (67–80%),
renal (9–19%)[3][9]
Identifiers
  • (3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2H-isoindole-1,3-dione
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
ECHA InfoCard100.225.187 Edit this at Wikidata
Chemical and physical data
FormulaC28H36N4O2S
Molar mass492.68 g·mol−1
3D model (JSmol)
Specific rotation[α]20D −59°
Melting point176 to 178 °C (349 to 352 °F)
Solubility in water0.224
  • C1CC[C@H]([C@@H](C1)CN2CCN(CC2)C3=NSC4=CC=CC=C43)CN5C(=O)[C@H]6[C@@H]7CC[C@@H](C7)[C@H]6C5=O
  • InChI=1S/C28H36N4O2S/c33-27-24-18-9-10-19(15-18)25(24)28(34)32(27)17-21-6-2-1-5-20(21)16-30-11-13-31(14-12-30)26-22-7-3-4-8-23(22)35-29-26/h3-4,7-8,18-21,24-25H,1-2,5-6,9-17H2/t18-,19+,20-,21-,24+,25-/m0/s1
  • Key:PQXKDMSYBGKCJA-CVTJIBDQSA-N

Lurasidone, sold under the brand name Latuda among others, is an antipsychotic medication used to treat schizophrenia and bipolar depression.[2] It is taken by mouth.

Common side effects include nausea, mild movement problems, sedation, and restlessness.[2] Serious side effects are valid for all atypical antipsychotics and may include the potentially permanent movement disorder tardive dyskinesia, as well as neuroleptic malignant syndrome, an increased risk of suicide, angioedema, and high blood sugar levels,[10] although lurasidone is less likely to cause high blood sugar levels in most patients, hyperosmolar hyperglycemic syndrome may occur.[2][11][12] In older people with psychosis as a result of dementia, it may increase the risk of dying.[2] Use during pregnancy is of unclear safety.[13][14]

Lurasidone was first approved for medical use in the United States in 2010.[2] In 2013, it was approved in Canada and by the U.S. Food and Drug Administration (FDA) to treat bipolar depression, either as monotherapy or adjunctively with lithium or valproate.[15][16] Generic versions were approved in the United States in 2019, and became available in 2023.[17][18] In 2021, it was the 193rd most commonly prescribed medication in the United States, with more than 2 million prescriptions.[19][20]

Medical uses

[edit]

Lurasidone is used to treat schizophrenia and bipolar disorder.[2][21] In bipolar disorder, it has been studied both as a monotherapy and adjunctive treatment to lithium or valproate.[22]

The European Medicines Agency approved lurasidone for the treatment of schizophrenia for people aged 13 years and older,[23] but not for bipolar disorder.[8] In the United States, it is used to treat schizophrenia for people aged 13 years and older, as well as depressive episodes of bipolar disorder age 10 and over as a monotherapy, and in conjunction with lithium or valproate in adults.[24]

In July 2013, lurasidone received approval for bipolar I depression.[25][26][27][28]

In June 2020, lurasidone was approved in Japan, eight years after its first approval in the United States.[29] In Japan it is approved for bipolar depression and schizophrenia.[30][31][32]

Few available atypical antipsychotics are known to possess antidepressant efficacy in bipolar disorder (with the notable exceptions being cariprazine,[33]quetiapine,[34][35][36][37] olanzapine[38][39][40] and possibly asenapine[41]) as a monotherapy, even though the majority of atypical antipsychotics are known to possess significant antimanic activity,[42] which is yet to be clearly demonstrated for lurasidone.

In the early post approval period lurasidone-treated patients with bipolar disorder were retrospectively found to have more complex clinical profiles, comorbidities, and prior treatment history compared to patients initiated with other atypical antipsychotics. The study authors suggest this may be due to "the overall clinical profile of lurasidone, the role perceived for lurasidone in the therapeutic armamentarium by practitioners, and the recent introduction of lurasidone into clinical practice during the study period."[43]

Lurasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.[44]

Contraindications

[edit]

Lurasidone is contraindicated in individuals who are taking strong inhibitors of the liver enzyme CYP3A4 (ketoconazole, clarithromycin, ritonavir, levodropropizine, etc.) or inducers (carbamazepine, St. John's wort, phenytoin, rifampicin etc.).[45] The use of lurasidone in pregnant women has not been studied and is not recommended; in animal studies, no risks have been found.[46] Excretion in breast milk is also unknown; lurasidone is not recommended for breastfeeding women.[47] In the United States it is not indicated for use in children.[48] The enzyme CYP3A4 is involved in the digestion of drugs. Inhibitors such as grapefruit juice block its function resulting in too much drug in the body.[49]

Side effects

[edit]
See also: List of adverse effects of lurasidone

Side effects are generally similar to other antipsychotics. The drug has a relatively well tolerated side effect profile, with low propensity for QTc interval changes,[50][51] weight gain and lipid-related adverse effects.[52] In a 2013 meta-analysis of the efficacy and tolerability of 15 antipsychotic drugs it was found to produce the second least (after haloperidol) weight gain, the least QT interval prolongation, the fourth most extrapyramidal side effects (after haloperidol, zotepine and chlorpromazine) and the sixth least sedation (after paliperidone, sertindole, amisulpride, iloperidone and aripiprazole).[53]

As with other atypical neuroleptics, lurasidone should be used with caution in the elderly because it puts them at an increased risk for a stroke or transient ischemic attack;[54][55] however, these risks are not likely to be greater than those associated with antipsychotics of other classes.[56] Similarly, lurasidone should not be used to treat dementia-related psychosis, as evidence has shown increased mortality with antipsychotic use.[57]

Weight gain is reported in up to 15 and 16 percent of users.[58][59] Other possible side effects include vomiting, akathisia, dystonia, parkinsonism, somnolence, dizziness, sedation and nausea.[60][61]

Discontinuation

[edit]

The British National Formulary recommends a gradual withdrawal when discontinuing antipsychotics to avoid acute withdrawal syndrome or rapid relapse.[62] Symptoms of withdrawal commonly include nausea, vomiting, and loss of appetite.[63] Other symptoms may include restlessness, increased sweating, and trouble sleeping.[63] Less commonly there may be a feeling of the world spinning, numbness, or muscle pains.[63] Symptoms generally resolve after a short period of time.[63]

There is tentative evidence that discontinuation of antipsychotics can result in psychosis.[64] It may also result in reoccurrence of the condition that is being treated.[65] Rarely tardive dyskinesia can occur when the medication is stopped.[63]

Interactions

[edit]

Blood plasma concentrations may be increased when combined with CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, ritonavir, and voriconazole) possibly leading to more side effects. This has been clinically verified for ketoconazole, which increases lurasidone exposure by a factor of 9, and is also expected for other 3A4 inhibitors such as grapefruit juice. Co-administration of CYP3A4 inducers like rifampicin, carbamazepine or St. John's wort can reduce plasma levels of lurasidone and its active metabolite, and consequently decrease the effects of the drug. For rifampicin, the reduction was sixfold in a study.[9]

Pharmacology

[edit]

Pharmacodynamics

[edit]
See also: Atypical antipsychotic § Pharmacodynamics, and Antipsychotic § Comparison of medications
Lurasidone[66]
Site Ki (nM) Action Species Ref
SERTTooltip Serotonin transporter >1,000 ND ND [67]
NETTooltip Norepinephrine transporter ND ND ND ND
DATTooltip Dopamine transporter >1,000 ND ND [67]
5-HT1A 6.75 Partial agonist Rat [67]
5-HT2A 2.03 Antagonist Rat [67]
5-HT2B 24 ND Human [68]
5-HT2C 415 ND Pig [67]
5-HT3 >1,000 ND ND [67]
5-HT4 >1,000 ND ND [67]
5-HT7 0.5 Antagonist Human [69][67]
α1 47.9 ND Rat [67]
α2A 41 Antagonist Human [67]
α2B ND ND ND ND
α2C 10.8 Antagonist Human [67]
β1 >1,000 ND ND [67]
β2 >1,000 ND ND [67]
D1 262 ND ND [67]
D2 1.68 Antagonist Rat [67]
D3 15.7 Antagonist ND ND
D4.4 30 Positive allosteric modulator ND ND
D5 ND ND ND ND
H1 >1,000 ND Guinea pig [67]
M1 >1,000 ND Human [67]
Values are Ki (nM). The smaller the value, the more strongly the drug binds to the site.

Lurasidone [(3aR,4S,7R,7aS)-2-{(1R,2R)-2-[4-(1,2-benzisothiazol-3-yl) piperazin-1-ylmethyl]-cyclohexylmethyl}-hexahydro-4,7-methano-2Hisoindole-1,3-dione hydrochloride] ][70] is an azapirone derivative[71] and acts as an antagonist of the dopamine D2 and D3 receptors,[72] and the serotonin 5-HT2A and 5-HT7 receptors, and the α2C-adrenergic receptor, and as a partial agonist of the serotonin 5-HT1A receptor. It has moderate-affinity antagonism at α2C-adrenergic receptors; low to very low-affinity antagonism at α1A-adrenergic α2A-adrenergic receptors.[73]

It has only low and likely clinically unimportant affinity for the serotonin 5-HT2C receptor, which may underlie its low propensity for appetite stimulation and weight gain.[67][74][75] The drug also has negligible affinity for the histamine H1 receptor and the muscarinic acetylcholine receptors, and hence has no antihistamine or anticholinergic effects.[76][77] Drowsiness (somnolence) side effect is not explained by its antagonist activity to histamine.[78][79]

The relationship between dose and D2 receptor occupancy levels were 41–43% for 10 mg, 51–55% for 20 mg, 63–67% for 40 mg, 77–84% for 60 mg, and 73–79% for 80 mg.[80]

Pharmacokinetics

[edit]
ID-14283, the main active metabolite. The hydroxylation of the norbornane ring is highlighted.[81] The other active metabolite, ID-14326, has the OH group in endo position.[82]
The main inactivation step by oxidative N-dealkylation produces the metabolites ID-11614 and ID-20219.[82][83]

Lurasidone is taken by mouth and has an estimated absorption rate of 9 to 19%.[3] Studies have shown that when lurasidone is taken with food, absorption increases about twofold. Peak blood plasma concentrations are reached after one to three hours. About 99% of the circulating substance are bound to plasma proteins.[9] Efficacy data for lurasidone have been evaluated for doses of 20 mg to 120 mg daily

Lurasidone is extensively metabolised by CYP3A4 leading to contraindication of both strong inhibitors as well as strong inducers of this enzyme,[84] but has negligible affinity to other cytochrome P450 enzymes. It is transported by P-glycoprotein and ABCG2 and also inhibits these carrier proteins in vitro. It also inhibits the solute carrier protein SLC22A1, but no other relevant transporters.[9][54]

Main metabolism pathways are oxidative N-dealkylation between the piperazine and cyclohexane rings, hydroxylation of the norbornane ring, and S-oxidation.[9][83]:59 Other pathways are hydroxylation of the cyclohexane ring and reductive cleavage of the isothiazole ring followed by S-methylation.[82] The two relevant active metabolites are the norbornane hydroxylation products called ID-14283 and ID-14326, the former reaching pharmacologically relevant blood plasma concentrations. The two major inactive metabolites are the N-dealkylation products (the carboxylic acid ID-20219 and the piperazine ID-11614[82]), and a norbornane hydroxylated derivative of ID-20219 (ID-20220). Of lurasidone and its metabolites circulating in the blood, the native drug makes up 11%, the main active metabolite 4%, and the inactive carboxylic acids 24% and 11%, respectively.[3][9] Several dozen metabolites have been identified altogether.[83]:59–61

Biological half-life is given as 18 hours or 20 to 40 hours in different sources. 80% or 67% of a radiolabelled dose was recovered from the feces, and 9% or 19% from the urine.[3][9]

History

[edit]

Lurasidone was first synthesised circa 2003.[85]

Lurasidone is a structural analogue of ziprasidone. Lurasidone shows a very close pharmacological profile and has been synthesized similarly to ziprasidone.[86]

Lurasidone is chemically similar to perospirone (also a chemical analogue of ziprasidone), as well as risperidone, paliperidone and iloperidone.[87]

It has approval from the US Food and Drug Administration (FDA) for treating schizophrenia since 2010, and for treating depressive episodes in adults with bipolar I disorder since 2013.[3]

Society and culture

[edit]
Latuda 40mg and 80mg bottles with 80mg tablets.
Latuda 40mg and 80mg bottles with 80mg tablets.

Cost

[edit]

In Canada, as of 2014, lurasidone is generally more expensive than risperidone and quetiapine but less expensive than aripiprazole.[88]

In the United States, because a number of doses have the same price per tablet, pill splitting has been used to decrease costs.[89] In 2019, generic versions were approved in the United States; however, they only became available in 2023 due to drug patents.[17][18]

Brand names

[edit]

In India, this drug is available under the brand names of Atlura, Lurace, Lurafic, Luramax (Sun Pharma), Lurasid, Lurastar, Latuda, Lurata[90] and additionally as Alsiva, Emsidon, Lurakem, Luratrend, Tablura, and Unisidon.[91]

Regulatory approval

[edit]

Lurasidone was approved in the United States for the treatment of schizophrenia in October 2010[92][93] and for the treatment of depressive episodes associated with bipolar I disorder in June 2013.[25][27][28] It received regulatory approval in the United Kingdom in September 2014. In October 2014, NHS Scotland advised use of lurasidone for schizophrenic adults who have not seen improvements with previous antipsychotics due to problems that arise from weight gain or changes in metabolic pathways when taking other medications.[94] The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for it in January 2014, and it was approved for medical use by the EMA in March 2014.[8] It was launched in Canada for the treatment of schizophrenia in September 2012, Health Canada giving their Summary Basis of Decision (SBD) as favourable on 15 October 2012.[95] The European Commission has granted a marketing authorization for once-daily oral lurasidone for the treatment of schizophrenia in adults.[96] It is approved for use in the EU.[8]

Generic versions of lurasidone were approved for use in the United States in January 2019, and became available in 2023.[97]

References

[edit]
  1. ^ "Lurasidone (Latuda) Use During Pregnancy". Drugs.com. 5 February 2020. Archived from the original on 15 October 2020. Retrieved 12 May 2020.
  2. ^ a b c d e f g "Lurasidone Hydrochloride Monograph for Professionals". Drugs.com. American Society of Health-System Pharmacists. Archived from the original on 21 March 2019. Retrieved 21 March 2019.
  3. ^ a b c d e f g h i "Product information Latuda (lurasidone hydrochloride)" (PDF). TGA eBusiness Services. Therapeutic Goods Administration. 28 October 2022. Archived from the original on 28 October 2022. Retrieved 28 October 2022.
  4. ^ "Prescription medicines: registration of new chemical entities in Australia, 2014". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  5. ^ Anvisa (31 March 2023). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 4 April 2023). Archived from the original on 3 August 2023. Retrieved 16 August 2023.
  6. ^ "Latuda 18.5mg film-coated tablets - Summary of Product Characteristics (SmPC)". (emc). 16 January 2019. Archived from the original on 14 October 2020. Retrieved 12 May 2020.
  7. ^ "Latuda- lurasidone hydrochloride tablet, film coated". DailyMed. Archived from the original on 28 August 2021. Retrieved 12 May 2020.
  8. ^ a b c d "Latuda EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 11 August 2020. Retrieved 12 May 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ a b c d e f g h i "Latuda: EPAR – Product Information" (PDF). European Medicines Agency. 14 April 2016. Archived (PDF) from the original on 21 August 2016. Retrieved 27 February 2017.
  10. ^ "IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA". Latuda. Archived from the original on 3 December 2022. Retrieved 3 December 2022.
  11. ^ Zhang Y, Liu Y, Su Y, You Y, Ma Y, Yang G, et al. (November 2017). "The metabolic side effects of 12 antipsychotic drugs used for the treatment of schizophrenia on glucose: a network meta-analysis". BMC Psychiatry. 17 (1): 373. doi:10.1186/s12888-017-1539-0. PMC 5698995. PMID 29162032.
  12. ^ Hanyu S, Kojima Y, Murai T, Kawashima H (September 2022). "Lurasidone-induced hyperosmolar hyperglycemic syndrome: A case report". Neuropsychopharmacology Reports. 42 (3): 377–379. doi:10.1002/npr2.12259. PMC 9515717. PMID 35609885.
  13. ^ British national formulary: BNF 76 (76 ed.). Pharmaceutical Press. 2018. pp. 393–394. ISBN 978-0-85711-338-2.
  14. ^ "Lurasidone (Latuda) tablets for the treatment of schizophrenia in adults" (PDF). Archived from the original (PDF) on 27 February 2021. Retrieved 30 April 2020.
  15. ^ Bawa R, Scarff JR (2015). "Lurasidone: a new treatment option for bipolar depression-a review". Innovations in Clinical Neuroscience. 12 (1–2): 21–23. PMC 4382136. PMID 25852975.
  16. ^ Pikalov A, Tsai J, Mao Y, Silva R, Cucchiaro J, Loebel A (December 2017). "Long-term use of lurasidone in patients with bipolar disorder: safety and effectiveness over 2 years of treatment". International Journal of Bipolar Disorders. 5 (1): 9. doi:10.1186/s40345-017-0075-7. PMC 5332323. PMID 28168632.
  17. ^ a b "Generic Latuda Availability". Drugs.com. Archived from the original on 14 August 2020. Retrieved 30 April 2020.
  18. ^ a b Hopkins JS (19 November 2019). "Generic-Drug Approvals Soar, But Patients Still Go Without". Wall Street Journal. Archived from the original on 27 April 2020. Retrieved 30 April 2020.
  19. ^ "The Top 300 of 2021". ClinCalc. Archived from the original on 15 January 2024. Retrieved 14 January 2024.
  20. ^ "Lurasidone - Drug Usage Statistics". ClinCalc. Retrieved 14 January 2024.
  21. ^ Swann AC, Fava M, Tsai J, Mao Y, Pikalov A, Loebel A (April 2017). "Lurasidone for major depressive disorder with mixed features and irritability: a post-hoc analysis". CNS Spectrums. 22 (2): 228–235. doi:10.1017/S1092852917000232. PMID 28300012. S2CID 24653390.
  22. ^ Ali Z, Tegin C, El-Mallakh RS (February 2020). "Evaluating lurasidone as a treatment option for bipolar disorder". Expert Opinion on Pharmacotherapy. 21 (3): 253–260. doi:10.1080/14656566.2019.1695777. PMID 31957501. S2CID 210829608.
  23. ^ "Latuda (lurasidone) An overview. European Medicines Agency, 2020" (PDF). Archived (PDF) from the original on 6 October 2022. Retrieved 6 October 2022.
  24. ^ Canadian Agency for Drugs and Technologies in Health (2014). "Key Limitations". Lurasidone Hydrochloride (Latuda): Management of Manifestations of Schizophrenia. Canadian Agency for Drugs and Technologies in Health. Archived from the original on 28 August 2021. Retrieved 30 April 2020 – via National Center for Biotechnology Information, U.S. National Library of Medicine.
  25. ^ a b Lowes R (2013). "Lurasidone Approved for Bipolar Depression". Medscape. Archived from the original on 2 October 2013. Retrieved 1 October 2013.
  26. ^ Bawa R, Scarff JR (2015). "Lurasidone: a new treatment option for bipolar depression-a review". Innovations in Clinical Neuroscience. 12 (1–2): 21–23. PMC 4382136. PMID 25852975.
  27. ^ a b "Latuda Supplement Approval Package 1" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 27 July 2020. Retrieved 12 May 2020.
  28. ^ a b "Latuda Supplement Approval Package 2" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 28 August 2021. Retrieved 12 May 2020.
  29. ^ "Latuda to Finally Hit Japan Market on June 11". PHARMA JAPAN. Archived from the original on 10 October 2022. Retrieved 10 October 2022.
  30. ^ "Sumitomo Dainippon Pharma Announces Approval of Atypical Antipsychotic Agent, LATUDA Tablets in Japan". IR News | Investor Relations. Sumitomo Pharma. Archived from the original on 10 October 2022. Retrieved 10 October 2022.
  31. ^ "Kusuri-no-Shiori(Drug Information Sheet) Latuda tablets". Archived from the original on 10 October 2022. Retrieved 10 October 2022.
  32. ^ Okubo R, Hasegawa T, Fukuyama K, Shiroyama T, Okada M (2021). "Current Limitations and Candidate Potential of 5-HT7 Receptor Antagonism in Psychiatric Pharmacotherapy". Frontiers in Psychiatry. 12: 623684. doi:10.3389/fpsyt.2021.623684. PMC 7930824. PMID 33679481.
  33. ^ Ragguett RM, McIntyre RS (April 2019). "Cariprazine for the treatment of bipolar depression: a review". Expert Review of Neurotherapeutics. 19 (4): 317–323. doi:10.1080/14737175.2019.1580571. PMID 30753085.
  34. ^ Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, et al. (EMBOLDEN I (Trial 001) Investigators) (February 2010). "A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I)". The Journal of Clinical Psychiatry. 71 (2): 150–162. doi:10.4088/JCP.08m04995gre. PMID 20122369.
  35. ^ Suppes T, Datto C, Minkwitz M, Nordenhem A, Walker C, Darko D (February 2010). "Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression". Journal of Affective Disorders. 121 (1–2): 106–115. doi:10.1016/j.jad.2009.10.007. PMID 19903574.
  36. ^ "Corrigendum". Bipolar Disorders. 10 (3): 451. 2008. doi:10.1111/j.1399-5618.2008.00585.x.
  37. ^ Thase ME (February 2008). "Quetiapine monotherapy for bipolar depression". Neuropsychiatric Disease and Treatment. 4 (1): 11–21. doi:10.2147/ndt.s1162. PMC 2515925. PMID 18728771.
  38. ^ Tohen M, Vieta E, Calabrese J, Ketter TA, Sachs G, Bowden C, et al. (November 2003). "Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression". Archives of General Psychiatry. 60 (11): 1079–1088. doi:10.1001/archpsyc.60.11.1079. PMID 14609883.
  39. ^ Tohen M, Katagiri H, Fujikoshi S, Kanba S (July 2013). "Efficacy of olanzapine monotherapy in acute bipolar depression: a pooled analysis of controlled studies". Journal of Affective Disorders. 149 (1–3): 196–201. doi:10.1016/j.jad.2013.01.022. PMID 23485111.
  40. ^ Corya SA, Perlis RH, Keck PE, Lin DY, Case MG, Williamson DJ, et al. (May 2006). "A 24-week open-label extension study of olanzapine-fluoxetine combination and olanzapine monotherapy in the treatment of bipolar depression". The Journal of Clinical Psychiatry. 67 (5): 798–806. doi:10.4088/JCP.v67n0514. PMID 16841630.
  41. ^ Azorin JM, Sapin C, Weiller E (February 2013). "Effect of asenapine on manic and depressive symptoms in bipolar I patients with mixed episodes: results from post hoc analyses". Journal of Affective Disorders. 145 (1): 62–69. doi:10.1016/j.jad.2012.07.013. PMID 22868059.
  42. ^ Cipriani A, Barbui C, Salanti G, Rendell J, Brown R, Stockton S, et al. (October 2011). "Comparative efficacy and acceptability of antimanic drugs in acute mania: a multiple-treatments meta-analysis". Lancet. 378 (9799): 1306–1315. doi:10.1016/S0140-6736(11)60873-8. PMID 21851976. S2CID 25512763.
  43. ^ Tohen M, Ng-Mak D, Rajagopalan K, Halpern R, Chuang CC, Loebel A (June 2017). "Patient Characteristics Associated With Use of Lurasidone Versus Other Atypical Antipsychotics in Patients With Bipolar Disorder: Analysis From a Claims Database in the United States". The Primary Care Companion for CNS Disorders. 19 (3). doi:10.4088/PCC.16m02066. PMID 28590601.
  44. ^ "Lurasidone". MedlinePlus. U.S. National Library of Medicine. Archived from the original on 23 January 2019. Retrieved 11 September 2018.
  45. ^ Chiu YY, Ereshefsky L, Preskorn SH, Poola N, Loebel A (2014). "Lurasidone drug-drug interaction studies: a comprehensive review". Drug Metabolism and Drug Interactions. 29 (3): 191–202. doi:10.1515/dmdi-2014-0005. PMID 24825095.
  46. ^ Pregnancy category
  47. ^ ACOG Committee on Practice Bulletins--Obstetrics (April 2008). "ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation". Obstetrics and Gynecology. 111 (4): 1001–1020. doi:10.1097/AOG.0b013e31816fd910. PMID 18378767.
  48. ^ Moore TA (April 2011). "Schizophrenia treatment guidelines in the United States". Clinical Schizophrenia & Related Psychoses. 5 (1): 40–49. doi:10.3371/CSRP.5.1.6. PMID 21459738.
  49. ^ Office of the Commissioner (14 July 2021). "Grapefruit Juice and Some Drugs Don't Mix". FDA.
  50. ^ Oral H (14 September 2018). "Lurasidone is not associated with risk of QTc prolongation". Clinical Research in Practice: The Journal of Team Hippocrates. 4 (2). doi:10.22237/crp/1536278400. ISSN 2379-4550. S2CID 53322344. Archived from the original on 15 November 2022. Retrieved 15 November 2022.
  51. ^ Javed A, Arthur H, Curtis L, Hansen L, Pappa S (December 2019). "Practical Guidance on the Use of Lurasidone for the Treatment of Adults with Schizophrenia". Neurology and Therapy. 8 (2): 215–230. doi:10.1007/s40120-019-0138-z. PMC 6858892. PMID 31098889.
  52. ^ "Lurasidone Demonstrated Efficacy in Treating Patients With Schizophrenia in Pivotal Phase 3 Study" (Press release). Dainippon Sumitomo Pharma. 26 August 2009. Archived from the original on 14 May 2015. Retrieved 3 October 2016.
  53. ^ Leucht S, Cipriani A, Spineli L, Mavridis D, Orey D, Richter F, et al. (September 2013). "Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis". Lancet. 382 (9896): 951–962. doi:10.1016/S0140-6736(13)60733-3. PMID 23810019. S2CID 32085212.
  54. ^ a b "Latuda: Prescribing Information". Psychotherapeutic Drugs. Archived from the original on 28 June 2011. Retrieved 17 December 2010.
  55. ^ "Latuda". Drugs.com. Archived from the original on 5 April 2019. Retrieved 17 December 2010.
  56. ^ Herrmann N, Mamdani M, Lanctôt KL (June 2004). "Atypical antipsychotics and risk of cerebrovascular accidents". The American Journal of Psychiatry. 161 (6): 1113–1115. doi:10.1176/appi.ajp.161.6.1113. PMID 15169702.
  57. ^ "Latuda Prescribing Information" (PDF). Sunovion Pharmaceuticals. Archived (PDF) from the original on 12 July 2018. Retrieved 25 March 2014.
  58. ^ Meyer JM, Mao Y, Pikalov A, Cucchiaro J, Loebel A (November 2015). "Weight change during long-term treatment with lurasidone: pooled analysis of studies in patients with schizophrenia". International Clinical Psychopharmacology. 30 (6): 342–350. doi:10.1097/YIC.0000000000000091. PMC 4593468. PMID 26196189.
  59. ^ Ketter TA, Sarma K, Silva R, Kroger H, Cucchiaro J, Loebel A (May 2016). "Lurasidone in the Long-Term Treatment of Patients with Bipolar Disorder: A 24-Week Open-Label Extension Study". Depression and Anxiety. 33 (5): 424–434. doi:10.1002/da.22479. PMC 5069590. PMID 26918425.
  60. ^ Zheng W, Cai DB, Yang XH, Li L, Zhang QE, Ng CH, et al. (August 2018). "Short-term efficacy and tolerability of lurasidone in the treatment of acute schizophrenia: A meta-analysis of randomized controlled trials". Journal of Psychiatric Research. 103: 244–251. doi:10.1016/j.jpsychires.2018.06.005. PMID 29906709. S2CID 49227958.
  61. ^ Kolli V, Walia A, Kinnan S (March 2019). "Food Matters: Reduction of Lurasidone-Induced Nausea With Meals". The Primary Care Companion for CNS Disorders. 21 (2): 18l02343. doi:10.4088/PCC.18l02343. PMID 30869204. S2CID 76666344.
  62. ^ BMJ Joint Formulary Committee (March 2009). "4.2.1". British National Formulary (57 ed.). United Kingdom: Royal Pharmaceutical Society of Great Britain. p. 192. ISBN 978-0-85369-845-6. Withdrawal of antipsychotic drugs after long-term therapy should always be gradual and closely monitored to avoid the risk of acute withdrawal syndromes or rapid relapse.
  63. ^ a b c d e Haddad PM, Dursun S, Deakin B, eds. (2004). Adverse Syndromes and Psychiatric Drugs: A Clinical Guide. OUP Oxford. pp. 207–216. ISBN 978-0-19-852748-0. Archived from the original on 10 January 2023. Retrieved 8 May 2020.
  64. ^ Moncrieff J (July 2006). "Does antipsychotic withdrawal provoke psychosis? Review of the literature on rapid onset psychosis (supersensitivity psychosis) and withdrawal-related relapse". Acta Psychiatrica Scandinavica. 114 (1): 3–13. doi:10.1111/j.1600-0447.2006.00787.x. PMID 16774655. S2CID 6267180.
  65. ^ Sacchetti E, Vita A, Siracusano A, Fleischhacker W (2013). Adherence to Antipsychotics in Schizophrenia. Springer Science & Business Media. p. 85. ISBN 978-88-470-2679-7. Archived from the original on 10 January 2023. Retrieved 8 May 2020.
  66. ^ Roth BL, Driscol J. "PDSP Ki Database". Psychoactive Drug Screening Program (PDSP). University of North Carolina at Chapel Hill and the United States National Institute of Mental Health. Archived from the original on 28 August 2021. Retrieved 14 August 2017.
  67. ^ a b c d e f g h i j k l m n o p q r Ishibashi T, Horisawa T, Tokuda K, Ishiyama T, Ogasa M, Tagashira R, et al. (July 2010). "Pharmacological profile of lurasidone, a novel antipsychotic agent with potent 5-hydroxytryptamine 7 (5-HT7) and 5-HT1A receptor activity". The Journal of Pharmacology and Experimental Therapeutics. 334 (1): 171–181. doi:10.1124/jpet.110.167346. PMID 20404009. S2CID 12893717.
  68. ^ Bender AM, Parr LC, Livingston WB, Lindsley CW, Merryman WD (August 2023). "2B Determined: The Future of the Serotonin Receptor 2B in Drug Discovery". J Med Chem. 66 (16): 11027–11039. doi:10.1021/acs.jmedchem.3c01178. PMC 11073569. PMID 37584406.
  69. ^ Tarazi FI, Riva MA (October 2013). "The preclinical profile of lurasidone: clinical relevance for the treatment of schizophrenia". Expert Opinion on Drug Discovery. 8 (10): 1297–1307. doi:10.1517/17460441.2013.815163. PMID 23837554. S2CID 25838798.
  70. ^ "(3aR,4S,7R,7aS)-2-[[(1R,2R)-2-[[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]methyl]cyclohexyl]methyl]hexahydro-4,7-methano-1H-isoindole-1,3(2H)-dione". PubChem. U.S. National Library of Medicine. Archived from the original on 2 December 2022. Retrieved 2 December 2022.
  71. ^ Amerio A, Giacomini C, Fusar-Poli L, Aguglia A, Costanza A, Serafini G, et al. (2021). "Efficacy and Safety of Lurasidone in Children and Adolescents: Recommendations for Clinical Management and Future Research". Current Pharmaceutical Design. 27 (39): 4062–4069. doi:10.2174/1381612827666210804110853. PMID 34348620. S2CID 236926992.
  72. ^ Fountoulakis KN, Gazouli M, Kelsoe J, Akiskal H (March 2015). "The pharmacodynamic properties of lurasidone and their role in its antidepressant efficacy in bipolar disorder". European Neuropsychopharmacology. 25 (3): 335–342. doi:10.1016/j.euroneuro.2014.11.010. PMID 25596883. S2CID 25628197.
  73. ^ Franklin R, Zorowitz S, Corse AK, Widge AS, Deckersbach T (19 August 2015). "Lurasidone for the treatment of bipolar depression: an evidence-based review". Neuropsychiatric Disease and Treatment. 11: 2143–2152. doi:10.2147/NDT.S50961. PMC 4547662. PMID 26316760.
  74. ^ Samalin L, Ben Gharbia M, Garnier M, Llorca PM (December 2014). "[Short-term efficacy and safety of lurasidone in the treatment of schizophrenia]" [Short-term efficacy and safety of lurasidone in the treatment of schizophrenia]. L'Encephale (in French). 40 (6): 507–517. doi:10.1016/j.encep.2014.10.009. PMID 25453735.
  75. ^ Lincoln J, Tripathi A (2011). "Lurasidone for Schizophrenia". Current Psychiatry. 10 (1): 67–70. Archived from the original on 3 October 2016. Retrieved 2 October 2016.
  76. ^ Ishiyama T, Tokuda K, Ishibashi T, Ito A, Toma S, Ohno Y (October 2007). "Lurasidone (SM-13496), a novel atypical antipsychotic drug, reverses MK-801-induced impairment of learning and memory in the rat passive-avoidance test". European Journal of Pharmacology. 572 (2–3): 160–170. doi:10.1016/j.ejphar.2007.06.058. PMID 17662268.
  77. ^ Greenberg WM, Citrome L (May 2017). "Pharmacokinetics and Pharmacodynamics of Lurasidone Hydrochloride, a Second-Generation Antipsychotic: A Systematic Review of the Published Literature". Clinical Pharmacokinetics. 56 (5): 493–503. doi:10.1007/s40262-016-0465-5. PMID 27722855. S2CID 207485482.
  78. ^ Cruz MP (August 2011). "Lurasidone HCl (Latuda), an Oral, Once-Daily Atypical Antipsychotic Agent for the Treatment of Patients with Schizophrenia". P & T. 36 (8): 489–492. PMC 3171824. PMID 21935296.
  79. ^ Corponi F, Fabbri C, Bitter I, Montgomery S, Vieta E, Kasper S, et al. (September 2019). "Novel antipsychotics specificity profile: A clinically oriented review of lurasidone, brexpiprazole, cariprazine and lumateperone". European Neuropsychopharmacology. 29 (9): 971–985. doi:10.1016/j.euroneuro.2019.06.008. hdl:11585/714012. PMID 31255396. S2CID 195699303.
  80. ^ Wong DF, Kuwabara H, Brašić JR, Stock T, Maini A, Gean EG, et al. (September 2013). "Determination of dopamine D₂ receptor occupancy by lurasidone using positron emission tomography in healthy male subjects". Psychopharmacology. 229 (2): 245–252. doi:10.1007/s00213-013-3103-z. PMID 23649882. S2CID 253737308.
  81. ^ Katteboina MY, Pilli NR, Mullangi R, Seelam RR, Satla SR (July 2016). "LC-MS/MS assay for the determination of lurasidone and its active metabolite, ID-14283 in human plasma and its application to a clinical pharmacokinetic study". Biomedical Chromatography. 30 (7): 1065–1074. doi:10.1002/bmc.3651. PMID 26577488.
  82. ^ a b c d Caccia S, Pasina L, Nobili A (2012). "Critical appraisal of lurasidone in the management of schizophrenia". Neuropsychiatric Disease and Treatment. 8: 155–168. doi:10.2147/NDT.S18059. PMC 3346058. PMID 22570547.
  83. ^ a b c "Lurasidone pharmacology review" (PDF). Center for Drug Evaluation and Research. 30 December 2009. Archived (PDF) from the original on 3 October 2016. Retrieved 2 October 2016.
  84. ^ "European Medicines Agency Assessment report Latuda International non-proprietary name: LURASIDONE Procedure No. EMEA/H/C/002713/0000" (PDF). Archived (PDF) from the original on 14 November 2022. Retrieved 14 November 2022.
  85. ^ "Leading Latuda through the crowd". 1 October 2011. Archived from the original on 28 August 2018. Retrieved 25 June 2017. Latuda was developed at an R&D facility established in Fort Lee, NJ, about eight years ago by Sunovion's Japanese parent Dainippon Sumitomo Pharma Co. (DSP).
  86. ^ Vardanyan R, Hruby V (7 January 2016). Synthesis of Best-Seller Drugs. Academic Press. ISBN 978-0-12-411524-8. Archived from the original on 11 April 2023. Retrieved 4 September 2017 – via Google Books.
  87. ^ "EXCLI Journal" (PDF). 17 November 2016. Archived from the original (PDF) on 17 November 2016.
  88. ^ Canadian Agency for Drugs and Technologies in Health (2014). "Summary of Pharmacoeconomic Submission". Lurasidone Hydrochloride (Latuda): Management of Manifestations of Schizophrenia. Canadian Agency for Drugs and Technologies in Health. Archived from the original on 28 August 2021. Retrieved 30 April 2020 – via National Center for Biotechnology Information, U.S. National Library of Medicine.
  89. ^ Carey H, Fondriest M (June 2017). "Cost-Savings From an Antipsychotic Tablet-Splitting Program". P & T. 42 (6): 384–393. PMC 5440099. PMID 28579725.
  90. ^ "'Lurasidone' drug search". CIMS India. Archived from the original on 28 August 2021. Retrieved 21 April 2018.
  91. ^ "Generic Drugs (ndrugs.com)". Archived from the original on 1 May 2018. Retrieved 30 April 2018.
  92. ^ "Drug Approval Package: Latuda (lurasidone hydrochloride) Tablets NDA #200603". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 25 February 2021. Retrieved 12 May 2020.
  93. ^ "FDA approves Latuda to treat schizophrenia in adults" (Press release). U.S. Food and Drug Administration (FDA). 28 October 2010. Archived from the original on 30 October 2010. Retrieved 29 October 2010.
  94. ^ "Lurasidone, 18.5mg, 37mg, 74mg film-coated tablets (Latuda) SMC No. (994/14)" (PDF). scottishmedicines.org.uk. Scottish Medicines Consortium. 2014. Archived from the original (PDF) on 8 March 2016. Retrieved 7 March 2016.
  95. ^ "Summary Basis of Decision (SBD) for Latuda". hc-sc.gc.ca. Health Canada. 2012. Archived from the original on 27 June 2013. Retrieved 19 June 2013.
  96. ^ "European Marketing Authorization for Latuda". takeda.com. Archived from the original on 26 December 2017. Retrieved 25 November 2015.
  97. ^ "Lurasidone: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 1 October 2020. Retrieved 12 May 2020.
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