Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Alkermes' Depression Drug Likely Needs Another Trial After Crushing US Advisory Cmte. Vote

Executive Summary

Nearly every panelist cited lack of substantial evidence of efficacy in voting against approval of ALKS 5461, a fixed-dose combination of buprenorphine and samidorphan.

You may also be interested in...



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

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.

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.

Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption

The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124186

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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