New antipsychotic drugs! Alks3831 (olanzapine / samidorphan) is under review in the United States for the treatment of schizophrenia and bipolar I disorder

January 29, 2020 / BIOON / -- Alkermes is a fully integrated Irish biopharmaceutical company dedicated to the development of innovative drugs for the treatment of central nervous system (CNS) diseases and tumors Recently, the company announced that the U.S Food and Drug Administration (FDA) has accepted the new drug application (NDA) of alks3831 (olanzapine / samidorphan), a new oral atypical antipsychotic drug, once a day, for the treatment of schizophrenia and bipolar I disorder The aim of the drug is to provide the efficacy of olanzapine and reduce the weight gain caused by olanzapine FDA has designated the target date of PDUFA as November 15, 2020 Alks3831 has four fixed dose combinations, which are made up of 10 mg of samidorphan and different doses of olanzapine (5 mg, 10 mg, 15 mg, 20 mg) Alkd3831 is a double layered tablet made of a novel molecular entity, samidorphan (a new selective μ - opioid receptor antagonist) and olanzapine, a listed antipsychotic drug Weight gain and clinical related metabolic problems are common side effects of atypical antipsychotic drugs Olanzapine is an effective antipsychotic drug, but its clinical use is limited by its high incidence of weight gain Alkd3831 is designed to provide olanzapine's powerful antipsychotic effect, while reducing the side effects on body weight and metabolism, so as to improve the safety of treatment ALKD3831 Data from the clinical development project of enlighten (including two key phase III studies, enlighten-1 and enlighten-2) in schizophrenics were included in the NDA, and data from the pharmacokinetic (PK) bridging study of alks3831 and Zyprexa (olanzapine) were compared to support the treatment of schizophrenic indications as well as adjuvant therapy as a single drug or as lithium or valproate Methods to treat bipolar I related manic depression or mixed attack, maintain treatment bipolar I disorder Samidorphan molecular structure formula (picture source: ebiochemicals Com) brighten-1 is a 4-week randomized, double-blind phase III study conducted in schizophrenics undergoing acute exacerbation The antipsychotic efficacy, safety and tolerance of alks3831 compared with placebo were compared The results showed that the primary end point of the study was achieved: compared with the placebo group, the positive and negative symptom scale (PANSS) scores in the alks3831 treatment group showed a statistically significant reduction from the baseline A olanzapine treatment group was also included in the study, but not to compare the efficacy or safety between alks3831 and olanzapine The study data showed a similar improvement in PANSS scores compared to baseline in the olanzapine group Enlighten-2 is a six-month, double-blind, phase III study conducted in stable schizophrenics to assess the effects of alks3831 and placebo on body weight The results showed that the study reached a common primary end point, indicating that compared with olanzapine treatment group, the average weight gain percentage of alks3831 treatment group from baseline at the 6th month of treatment was lower, and the proportion of patients with weight gain ≥ 10% at the 6th month of treatment was lower Craig Hopkinson, MD, chief medical officer and senior vice president of drug development and medical affairs of Alkermes, said: "FDA's acceptance of new drug applications for alks3831 marks a major milestone in our goal of providing new treatment options to patients with schizophrenia and bipolar disorder We believe that alks3831 has the potential to provide a meaningful new product for these patients with severe and complex mental diseases, and we look forward to working closely with FDA throughout the NDA review process