Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Remoxy Review Leaves US FDA Wondering: Where Is The Real-World Data On ADFs?

Executive Summary

FDA’s Sharon Hertz opened up an advisory committee review of PTI’s proposed abuse-deterrent formulation of Remoxy by remarking on the absence of data about the real-world impact of approved ADFs. That doesn’t have much to do with Remoxy – which appears headed to yet another rejection – but it is an important message for other sponsors of opioid therapies to heed.

You may also be interested in...



Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations

Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.

Not Another Opana: US FDA Panel Rejects PTI’s Remoxy On Intravenous Abuse Concerns

Studies showing oxycodone could be extracted for intravenous use troubled advisory committee members, who worried it would result in the same types of adverse public health effects that led to market withdrawal of Endo’s Opana ER; panelists also were concerned about the ability to partially defeat Remoxy’s extended-release properties by chewing the product.

FDA Rebukes Egalet's Reliance On OxyContin Postmarketing Data

Arymo ER sponsor's consultants said Purdue's postmarketing data on its reformulated oxycodone establish a link between abuse-deterrent properties and reduced real-world abuse, but FDA says it disagreed with the conclusion in the context of an OxyContin labeling supplement.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS123390

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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