Formheasann FDA na SA Caplyta (lumateperone): cóireáil ar eipeasóid dhúlagair de chineál I nó de chineál II a bhaineann le neamhord dépholach!

Intra-Cellular Therapies (ICT) is a biopharmaceutical company focused on developing innovative therapies to treat central nervous system (CNS) diseases. Recently, the company announced that the US Food and Drug Administration (FDA) has approved Caplyta (lumateperone) for a new indication: as a monotherapy and as an adjuvant therapy with lithium or valproate for the treatment of adult patients Treat depressive episodes associated with bipolar type I or type II disorder (bipolar depression).

Is fiú a lua gurb é Caplyta an t-aon druga atá ceadaithe ag FDA na SA mar mhonaiteiripe agus mar theiripe aidiúvach litiam nó valproate chun cóireáil a dhéanamh ar eipeasóid dhúlagráin a bhaineann le neamhord de chineál I do dhaoine fásta nó de chineál II. Léiríonn sonraí cliniciúla go bhfuil feidhmíocht mhaith comhsheasmhach ag Caplyta i dtéarmaí meáchan coirp, paraiméadair cardiometabolic, agus comharthaí extrapyramidal (dyskinesias).

Caplyta was approved by the US FDA in December 2019 for the treatment of adult patients with schizophrenia. In terms of medication, the recommended dose of Caplyta is 42 mg, once a day, taken with food, no dose titration is required. It should be noted that Caplyta's drug label contains a black box warning that: patients with dementia-related psychosis use antipsychotic drugs to increase the risk of death; Caplyta is not approved for the treatment of patients with dementia-related psychosis.

Tá formheas an táisc nua bunaithe ar thorthaí dearfacha dhá chéim 3 staidéar ar dhúlagar bithpolar-rialaithe phlaicéabó. Rinne na staidéir seo measúnú ar éifeachtaí Caplyta mar mhonaiteiripe (Staidéar 404), mar theiripe aidiúvach litiam nó valproate (Staidéar 402) ar eipeasóid dúlagair i ndaoine fásta le neamhord bipolar I nó bipolar II. Sna staidéir seo, socraíodh éifeachtúlacht Caplyta 42mg trí fheabhas staitistiúil a thaispeáint ar scór iomlán Scála Rátála Dúlagair Montgomery-Asperger (MADRS) i gcomparáid leis an mbunlíne ag an 6ú seachtain de chóireáil. Léirigh Caplyta 42mg freisin feabhas suntasach go staitistiúil ar phríomhphointí tánaisteacha a bhaineann leis an tuiscint chliniciúil iomlán ar neamhord bipolar i ngach staidéar.

In addition, Caplyta showed good tolerability and safety, consistent with the results of previous clinical studies on schizophrenia. The most common adverse reactions (incidence ≥5% and at least twice that of placebo) are drowsiness/sedation, dizziness, nausea, and dry mouth. The Caplyta group and the placebo group had similar changes in body weight, fasting blood glucose, total cholesterol, triglycerides, and low-density lipoprotein cholesterol to the baseline.

Bipolar I and Bipolar II disorders are serious, highly prevalent mental chronic diseases that affect approximately 11 million adults in the United States. They are characterized by recurrent mania or hypomania, which is called bipolar disorder. Depressive major depressive episode. Bipolar I and Bipolar II each account for half of the total number of patients with bipolar disorder. Bipolar depression is the most common clinical manifestation of bipolar disorder. These depressive episodes tend to last longer, relapse more frequently, and have a worse prognosis than manic/hypomanic episodes. Bipolar depression is still a severely inadequate medical need, and only a few FDA-approved therapies are available. These therapies are usually related to tolerability issues.

Is é comhábhar gníomhach cógaisíochta Caplyta ná lumateperone, arb é druga móilín beag den chéad scoth é a fhéadfaidh serotonin, dopamine agus glutamáit a mhodhnú go roghnach agus go comhuaineach, na trí neurotransmitters a bhfuil baint acu le meabhairghalar tromchúiseach. Conair cháilíochtúil. Tá sé léirithe ag staidéir chógasdhinimiciúla go bhfuil ard-chleamhnas ceangailteach ag lumateperone, mar fhrithghníomhaí cumasach, ar ghabhdóirí serotonin 5-HT2A, mar fhrithghníomhaí, go bhfuil cleamhnas measartha ceangailteach aige ar ghabhdóirí postsynaptic D2, agus mar chineál coscairí athghabhála iompróir Serotonin (SERT). cleamhnas measartha do ghabhdóirí D1 (d'fhéadfadh sé seo cur le gníomhachtú indíreach gabhdóirí AMPA agus NMDA). Ceaptar go bhfuil ról tábhachtach ag na gabhdóirí seo i scitsifréine, neamhord bipolar, dúlagar, agus galair néarshíciatracha eile. Tá sé léirithe ag staidéir in vitro, i gcomparáid le gabhdóirí D2, go bhfuil cleamhnas ag lumateperone do ghabhdóirí 5-HT2A thart ar 60 uair níos airde.

In the United States, the FDA granted lumateperone fast track status for the treatment of schizophrenia in November 2017. In addition to schizophrenia, ICT companies are also developing lumateperone to treat bipolar depression, depression, and other neuropsychiatric and neurological diseases.

Tá an tionscal an-dóchasach faoi ionchais Caplyta &. Tá EvaluatePharma, eagraíocht taighde margaidh cógaisíochta, ag tuar go sroichfidh díolacháin Caplyta' in 2026 2 billiún dollar SAM, leath de ag teacht ó scitsifréine, agus an leath eile ag teacht ó dhúlagar dépholach.