New antipsychotic drugs! ALKS3831 (O nitrogenpin/samidorphan) is about to be approved in the United States: Treatment of schizophrenia/biphalia type I disorder.

October 10, 2020 // -- 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 announced positive results from a joint meeting of the U.S. Food and Drug Administration's Advisory Committee on Psychotic Drugs and the Advisory Committee on Drug Safety and Risk Management.
committee met to discuss the antipsychotic drug APKS3831 (olanzapine/samidorphan), a new, daily atypical antipsychotic drug in study for the treatment of adult schizophrenia and adult bisozophrenia.
committee voted that Samidorphan had meaningfully reduced the weight gain caused by olanzapine (16 votes in favour, 1 against) and that the safety characteristics of ALKS3831 were fully described (13 votes in favour, 3 against, 1 abstention).
, the committee voted jointly that drug labeling was sufficient to mitigate the risks associated with the effects of samidorphan opioid antagonists (11 votes in favor and 6 against).
Alkermes recommended that drug labels prohibit the use of APKS3831 in patients who are dependent on or long-term opioid users, and the company has proposed a comprehensive education program that includes disseminating information to potential prescribers and pharmacists.
recommendations of the Joint Advisory Committee, although non-binding, will be taken into account by the FDA in its review of the APKS3831 New Drug Application (NDA).
, the FDA has designated APKS3831 NDA's Prescription Drug User Charges Act (PDUFA) target date for action as November 15, 2020.
's samidorphan molecular structure (Photo: ebiochemicals.com) ALKD3831 is a double-layer tablet made from a novel new molecular entity, samidorphan (a new selective μ-opioid subject antagonist) and a marketed antipsychotic drug, olanzapine.
and clinically related metabolic problems are common side effects of atypical anti-schizophrenic drugs.
is an effective antipsychotic drug, but clinical use is limited by its high-risk weight gain.
design of ALKD3831 seeks to improve the safety of treatment by reducing the side effects on weight and metabolism while providing strong antipsychotic efficacy.
APKS3831 is a new oral atypical antipsychotic drug, developed once a day to treat schizophrenia and biplex type I disorders.
the drug is designed to provide the efficacy of olanzapine while reducing the weight gain caused by onoicine.
, ALKS3831 is currently under review by the FDA with a target date of November 15, 2020.
ALKS3831 has 4 fixed dose combinations, consisting of 10 mg doses of samidorphan and different doses of oestration (5 mg, 10 mg, 15 mg, 20 mg).
Alkermes Chief Medical Officer and Executive Vice President of Research and Development, Dr. Craig Hopkinson, M.D., said, "The good outcome of today's joint advisory committee meeting represents an important milestone for patients, clinicians, and families who may benefit from the new drug treatment for schizophrenia and bipolar disorder.
personal testimony shared at today's public hearing reinforces the need to consider treatments for the overall physical and mental health of patients.
APKS3831 development is part of our ongoing commitment to developing new treatments for adults with severe mental illness.
today's results mark an important step forward for this project and we look forward to working with the FDA as it completes its review of APKS3831's new drug applications.
" ALKD3831 NDA includes data from ENLIGHTEN clinical development projects in patients with schizophrenia (including 2 key Phase III studies ENLIGHTEN-1, ENLIGHTEN-2), comparison of ALKS3831 and listed drug Zy Prexa pharmacodynamics (PK) bridges the study's data to support the treatment of schizophrenia adaptation, as well as the treatment of bipolar disorder or mixed seizures associated with bipolar disorder as a single drug or as an auxiliary therapy for lithium or sodium valproate.
ENLIGHTEN-1 is a 4-week randomized, double-blind Phase III study conducted in patients with schizophrenia who are experiencing acute exacerbation, comparing the antipsychotic efficacy, safety and tolerance of APKS3831 relative to placebo.
results showed that the study reached its primary endpoint: the positive and negative symptom scale (PANSS) scores of the ALKS3831 treatment group showed a significant statistically significant decrease compared to the placebo group.
the study also included a group of otoxyntherapy groups, but not to compare the efficacy or safety between APKS3831 and oxypine.
study data showed a similar improvement in the pansS score relative to baseline changes in the on-nitrogen treatment group compared to the placebo group.
ENLIGHTEN-2 was a six-month book, double-blind Phase III study that assessed the weight effects of APKS3831 and placebo in patients with stable schizophrenia.
results showed that the study reached a common primary endpoint, showing that the ALKS3831 treatment group had a lower percentage of weight gain from the baseline at the 6th month of treatment and a lower percentage of patients who gained ≥10% in the 6th month of treatment≥
() Original source: FDA Advisory Committee Votes in Support of ALKS 3831 for The Treatment of Schizophrenia and Bipolar I Disorder.