New Drug Approvals

The information below is derived from a clinical study database for Latuda consisting of over 2096 patients with schizophrenia exposed to one or more doses with a total experience of 624 patient-years. Of these patients, 1004 participated in short-term placebo-controlled schizophrenia studies with doses of 20 mg, 40 mg, 80 mg or 120 mg once daily. A total of 533 Latuda-treated patients had at least 24 weeks and 238 Latuda-treated patients had at least 52 weeks of exposure.

Latuda has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with Latuda did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of Latuda misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).

Its chemical name is (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 hydrochloride. Its molecular formula is C28H36N4O2S-HCI and its molecular weight is 529.14. Lurasidone hydrochloride is a white to off-white powder.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients.

Drug Name: LATUDA (Brand Name Drug) Active Ingredient: LURASIDONE HYDROCHLORIDE FDA Application No.: (NDA) 200603 Company: Sunovion Pharma, Inc. These highlights do not Include all the Information needed to use Latuda safely and effectively. See full prescribing Information (FPI) for Latuda.

Latuda is not a substrate of CYP1A1, CYP1A2, CYP2A6, CYP4A11, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP2E1 enzymes. This suggests that an interaction of Latuda with drugs that are inhibitors or inducers of these enzymes is unlikely.

The efficacy of Latuda for the treatment of schizophrenia was established in four short-term (6-week), placebo-controlled studies in adult patients (mean age of 38.8 years, range 18-72) who met DSM-IV criteria for schizophrenia. One study included an active-control arm (olanzapine) to assess assay sensitivity. Positive and Negative Syndrome Scale (PANSS), is a multi-item inventory of general psychopathology used to evaluate the effects of drug treatment in schizophrenia.