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

Opioid Clinical Efficacy Standards Need Rethinking, FDA Panel Says

Executive Summary

Outcomes measures should go beyond self-reported pain scores to include effects on function and quality of life, advisory committee members said during review of Teva's long-acting opioid Vantrela.

You may also be interested in...



Opioid Policy At US FDA: Gottlieb Seeks More Activist Role To Combat Abuse

‘Dramatic action’ needed to curb opioid epidemic, commissioner-nominee says, including potentially a cross-center approach to evaluating drugs and devices for pain, and new nomenclature for formulations currently labeled as abuse deterrent.

Opioid Approval Standards Not Up For Debate, FDA Tells Advisory Cmte.

As Egalet's Arymo ER heads to panel, agency tries to head off discussion about whether it should be approving new opioid products and whether longer clinical efficacy trials should be demanded.

Egalet's Arymo ER Opioid Has Questionable Oral Abuse-Deterrent Effect

Drug liking score in human oral abuse study shows small but statistically significant difference, and clinical relevance is unclear, FDA says in advisory committee briefing documents.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057711

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