Painkiller Remoxy (Oxycodone) May Still See An NDA Refiling By Mid-2015 (PTIE) – Seeking…

Summary

  • Pfizer announced it was returning the Remoxy rights to the initial filers of the NDA, Pain Therapeutics, the shares of which sank 53% on the news.
  • However, a search on ClinicalTrials.gov reveals that Pfizer has completed all the necessary Phase I bioequivalence trials required to address the FDA‘s last Complete Response Letter.
  • That may be enough to attract a new partner for the (more…)

Pfizer Inc. Continues Development Program for Remoxy® (oxycodone … – Business Wire…

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that, having achieved technical milestones related to manufacturing, it will continue the development program for Remoxy® (oxycodone) Extended-Release Capsules CII. Following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received (more…)

Pain Therapeutics – Another Oxycodone Remix – Seeking Alpha

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Collaborations and reinvention are common in the development (more…)