New antipsychotic drugs! ALKS3831 (Otspin/samidorphan) has been re-accepted by the FDA: Treatment of Schizophrenia/Biphasy Type I Disorder

December 30, 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.
recently, the company announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the company's refilement of the ALTDS3831 (olanzapine/samidorphan) new drug application (NDA), a new, daily atypical antipsychotic drug for the treatment of adult schizophrenia and adult biphasia 1 disorder.
the FDA has designated the target date for the new Prescription Drug User Charge Act (PDUFA) as June 1, 2021.
the FDA classified the resubmitted report as a full secondary response to a full response letter (CRL) issued in November 2020.
At that time, following a remote review of the company's production records for APKS3831 at the company's Plant in Wimington, Ohio, as required by Section 704 (a) (4) of the Federal Food, Drug and Cosmetic Act ("FDCA"), the FDA issued a CRL indicating certain issues related to the tablet packaging process, which were specific to certain development batches of APKS3831.
alkermes resubmits the NDA, the FDA issued a new record request under FDCA Section 704 (a) (4) to supplement the company's previous information.
CRL and subsequent record requests did not identify or raise any questions about clinical or non-clinical data in the NDA, nor did the FDA require Alkermes to complete any new clinical trials to support NDA approval.
alkermes will continue to work closely with the FDA to complete the review of the APKS3831 NDA and is committed to providing APKS3831 to patients as soon as possible.
ALKD3831 is a double-layer tablet made from a novel new molecular entity, samidorphan (a new selective μ-opioid-opioid-agent antagonist), and a marketed antipsychotic drug, olanzapine.
and clinically related metabolic problems are common side effects of atypical antischizophrenic 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 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).
, the FDA Advisory Committee on Psychopants and the Advisory Committee on Drug Safety and Risk Management met to discuss APKS3831.
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' proposed drug labeling bans the use of APKS3831 in patients who are dependent on or long-term opioid users, the company has also proposed a comprehensive education program that includes disseminating information to potential prescribers and pharmacists.
ALKD3831 NDA includes data from ENLIGHTEN clinical development projects in patients with schizophrenia (including 2 key Phase III studies ENLIGHTEN-1.com, ENLIGHTEN-2) and comparison of ALK Data from the S3831 and the listed drug Zyprexa Pharmacodynamics (PK) bridge studies 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 ad-aid 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 origin: FDA Accepts Alkermes' Resubmision of New Drug application for ALKS 3831