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-Sparing Regimens Face High Hurdles After US FDA Advisory Cmte.

Executive Summary

Panelists felt the phrase "opioid sparing" was too broad, and contended that it is difficult to develop a non-opioid alternative without an opioid as an active comparator. 

You may also be interested in...



Time To Spare? US FDA “Opioid-Sparing” Guidance May Take Longer Than Expected

In August, it sounded like FDA was almost ready to issue guidance on “opioid-sparing” claims for acute pain treatments. After a November advisory committee meeting, that doesn’t seem to be the case.

Unintended Consequences Of Broad Opioid-Sparing Claims Worries US Panel

FDA advisory committee members raise concerns about inappropriate marketing and prescribing practices. 

US FDA Likely Cannot Force Sponsors To Fund Opioid Prescribing Guideline Trials

Once the National Academies of Sciences, Engineering and Medicine find conditions needing more evidence to support prescribing guidelines, the agency may have find a way to gather the data.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS124266

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