Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Alkermes’ Antipsychotic Combo Faces US FDA Questions On Metabolic Effects, Opioid-Related Safety

Executive Summary

ALKS 3831, which combines olanzapine with the mu opioid receptor antagonist samidorphan, was associated with less weight gain compared to olanzapine alone but showed no benefit on metabolic parameters; in advisory committee briefing documents, agency raises theoretical safety concerns about drug’s opioid antagonistic effects in real-world settings.

You may also be interested in...



Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Keeping Track: Submissions From Alkermes, Samsung Bioepis; BTDs for Orphazyme and Kiniksa

The latest submission and expedited review program news and highlights from our US FDA Performance Tracker.

Keeping Track: FDA Approves First Generic Advair, But Alkermes And Sunovion Land CRLs

The latest drug development news and highlights from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID014775

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel