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

Never Surrender: Pain Therapeutics Eyes 2016 Remoxy Filing

This article was originally published in The Pink Sheet Daily

Executive Summary

Pain Therapeutics said it will file the opioid with FDA in the first quarter of 2016, based on clinical trial data conducted by its former partner Pfizer.

You may also be interested in...



Pain Therapeutics Confident It Has US Approval Pathway Set For Remoxy ER

Biotech says it can complete two FDA-mandated studies by year-end and re-file the NDA rejected three times previously by the US agency. Pain Therapeutics also says it will not attempt to commercialize the abuse-deterrent opioid product without a partner.

Keeping Track: FDA On A Complete Response Spree?

The latest drug development news and highlights from our FDA Performance Tracker.

Remoxy Development Not ‘Unmitigated Disaster,’ CEO Reassures; Hunt Begins For New Partner

Pfizer terminates agreement with Pain Therapeutics after reviewing top-line results of five studies done to address FDA complete response letter; Pain says data supports refiling of NDA for its abuse-deterrent long-acting oxycodone formulation by mid-2015.

Related Content

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

PS078470

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