Scrip 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

FDA Moves On Endo’s Opana ER Unlikely To Sweep Up Other Opioids

Executive Summary

Shift toward intravenous abuse with the reformulated long-acting opioid, coupled with reports of a serious bleeding disorder and HIV transmission, spurred US FDA advisory committee to recommend regulatory action, which could include new labeling, strict risk management measures or market withdrawal.

You may also be interested in...



PTI’s Remoxy: Negative FDA Panel Review May Be The End Of Abuse-Deterrent Opioid's Road

Concerns that the extended-release oxycodone product poses the same potential for intravenous abuse as Endo’s withdrawn Opana ER drive FDA advisory committee recommendation against approval, laying the groundwork for a fourth complete response letter; FDA’s comparison of Remoxy to Opana during the meeting ‘borders on slanderous,’ PTI CEO Barbier tells Scrip, predicting sponsors will be dissuaded by the shifting regulatory goalposts for abuse-deterrent formulations.

Finance Watch Public Company Edition: Akcea, Kala Launch IPOs While FOPOs Keep Busy Pace

Kala follows July's first biopharma IPO from Ionis spinout Akcea into the stock market. Amicus, Arena and othera go high with major offerings, while Inovio and Regulus go low. Also, Galena, Neothetics provide updates on their hunts for "strategic alternatives."

Nektar Turns Up The Heat On Partnering Talks For NKTR-181

The company reported positive Phase III efficacy data on the first-in-class mu-opioid agonist molecule designed to provide pain relief without the euphoria that leads to addiction with standard opioids.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC098410

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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