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' Vivitrol For Opioid Dependence Could Be Dealt Wild Card At Advisory Committee

This article was originally published in The Pink Sheet Daily

Executive Summary

Expert panels have recently shown they may think differently from FDA on the subject of opioids..

You may also be interested in...



FDA Opioid REMS Proposal Leaves Advisory Panel Wanting More - i.e. Mandatory Training

Prior training programs have been much smaller in scope, OND Director John Jenkins points out.

Opioid Addiction Indication Could Offer Fix For Alkermes' Troubled Vivitrol

Alkermes' four-year-old Vivitrol has been struggling to get its head above water as a therapy for alcoholism. But fast-track status for a new opioid addiction indication and a slew of supportive studies at the American Psychiatric Association meeting offer the $900-a-month injectable a shot at recovery

Quandary Remains In Creating Abuse-Resistant Opioid Painkillers

FDA's advisory committees honed in on the inherent paradox in the regulation of abuse-resistant opioid painkillers - that it is impossible to fully prove an abuse-deterrent effect without approving a product and seeing how it works on the market - at the April 22 review of King/Acura's Acurox

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS071131

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