ALKSALKS

Psychiatry40 cited findings · profile updated 2026-08-26

About ALKS

ALKS (ALKS) is a company focused on psychiatry. Their drug, ALK3831-A303, was studied in a Phase 3 trial. The trial, ALK3831-A303, had an initial planned total randomized subjects of 400, which was later increased to a target sample size of 270 subjects per arm. The study ultimately randomized 561 subjects, with 280 subjects randomized to ALKS 3831 and 281 subjects randomized to olanzapine. The safety population for ALKS 3831 development included 2004 N, and the safety population for samidorphan development included 724 N. The PDUFA Goal Date for Lybalvi was November 15, 2020, with an Action Date and Review Completion Date of November 13, 2020.

Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.

Key figures — cited

Advisory Committee vote: adequate evidence samidorphan mitigates olanzapine-associated weight gain	16 Yes votes	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.35
Advisory Committee vote: labeling sufficient to mitigate risks related to opioid antagonist action of samidorphan	11 Yes votes	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.35
Advisory Committee vote: Applicant adequately characterized safety profile of ALKS 3831	13 Yes votes	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.35
PDUFA Goal Date	November 15, 2020	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.42
Action Date	November 13, 2020	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.42
Review Completion Date	November 13, 2020	Alkermes plc — Lybalvi FDA Review (NDA213378, ORIG 1, 2021), p.42

Key projects

ALK3831-A303 (psychiatry)
The trial ALK3831-A303 had a planned total randomized subjects (initial) of 400 subjects.

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