Tags: Health Topics | Chronic Pain | opioid | fda

FDA Declines to Approve Pain Therapeutics' Abuse-Deterrent Opioid Drug

FDA Declines to Approve Pain Therapeutics' Abuse-Deterrent Opioid Drug
(Dreamstime)

Monday, 06 August 2018 07:48 AM

Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk.

"This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction," said Chief Executive Officer Remi Barbier said in a statement.

The FDA's "complete response letter" marks the latest setback to the U.S. drug developer and the treatment, Remoxy ER, which has failed to get marketing approval on the past three attempts.

The drug developer also said it had initiated a strategic reorganization to align its resources to focus on its treatments and diagnostic products for Alzheimer's disease.

The drug is a capsule formulation of the commonly-used opioid oxycodone

The regulator's decision comes amid increased public and regulatory scrutiny in the United States over the use of opioid drugs, the abuse of which has reached epidemic proportions in the country.

"I believe Remoxy received an ideological judgement call that is vague in nature but conclusive in its damaging effects," Barbier said.

© 2021 Thomson/Reuters. All rights reserved.


Health-News
Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk.
opioid, fda
188
2018-48-06
Monday, 06 August 2018 07:48 AM
Newsmax Media, Inc.
 
Newsmax TV Live

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved