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Alkermes Announces Posting of Briefing Documents for FDA Advisory Committee Meeting on ALKS 3831
DUBLIN, Oct. 7, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website
About this update from Alkermes Plc
[{"type":"text","content":"DUBLIN, Oct. 7, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Oct. 9, 2020 joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee to review the company's New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder.\nThe joint advisory committee meeting, which is being held virtually, is scheduled to begin at 10:00 a.m. ET on Friday, Oct. 9, 2020. Both Alkermes and the FDA have prepared pre-recorded presentations, which will be viewed by the joint advisory committee prior to the meeting and will not be replayed during the meeting. The briefing materials, including the pre-recorded presentation slides and transcripts, are now posted to the FDA website and can be accessed here: https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-agenda-and-meeting-materials-october-9-2020-joint-meeting-psychopharmacologic-drugs.\nThe FDA has also established a docket for public comment on this meeting. The docket number is FDA-2020-N-1767 and can be accessed here: https://beta.regulations.gov/document/FDA-2020-N-1767-0001/comment.\nThe Prescription Drug User Fee Act (PDUFA) target action date for the ALKS 3831 NDA is Nov. 15, 2020.\nAbout ALKS 3831ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder. ALKS 3831 is composed of samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, olanzapine, in a single bilayer tablet.\nAbout Schizophrenia Schizophrenia is a serious brain disorder marked by positive symptoms (hallucinations and delusions, disorganized speech and thoughts, and agitated or repeated movements) and negative symptoms (depression, blunted emotions and social withdrawal).1 An estimated 2.4 million American adults have schizophrenia,2 with men and women affected equally.\nAbout Bipolar I DisorderBipolar disorder is a brain disorder that ...