New antipsychotic drugs! Alks3831 (olanzapine / samidorphan) applied for listing in the United States to treat schizophrenia and bipolar I disorder

November 20, 2019 / 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 The company has a diversified business product portfolio and a large number of clinical candidates for the treatment of a variety of diseases, including schizophrenia, depression, addiction, multiple sclerosis and cancer Recently, the company announced that it has submitted the new drug application (NDA) of alks3831 (olanzapine / samidorphan) to the U.S Food and Drug Administration (FDA), a new oral atypical antipsychotic drug, once a day, for the treatment of schizophrenia and bipolar I disorder 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 The data of energy clinical development project in schizophrenics were included in alkd3831 NDA The project includes two key phase III studies (enlighten-1, enlighten-2), as well as supporting studies to assess the pharmacokinetic and metabolic characteristics and long-term safety of alks3831, and to compare the pharmacokinetic (PK) bridging studies of alks3831 and Zyprexa (olanzapine) 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: "antipsychotics are an important part of the treatment model of schizophrenia and bipolar disorder, but the demand for new treatment methods has not been met The submission of alks3831 NDA reflects Alkermes' commitment to developing new therapies for severe and widespread central nervous system diseases, as well as our long-term commitment to mental health disorders We are pleased to submit this application for the approval of alks3831, and we look forward to working with FDA to bring this potential new drug to patients and medical professionals " Original source: Alkermes submissions new drug application to U.S Food and Drug Administration for alks 3831 for treatment of schizophrenia and bipolar I disorder