Now Who Needs a Painkiller? King and Pain Therapeutics Face a Remoxy Setback
This article was originally published in The Pink Sheet Daily
Executive Summary
A filing is now expected in mid-2010, although the delay looks to be a bigger hit to Pain Therapeutics than King, S&P analyst says.
You may also be interested in...
Never Surrender: Pain Therapeutics Eyes 2016 Remoxy Filing
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.
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.
Pfizer’s Remoxy Clears Manufacturing Hurdle, Still Needs BE, Abuse-Potential Studies
Extended-release oxycodone product has potential for broader abuse-deterrent claims than OxyContin; Pfizer expects to resubmit Remoxy to FDA by mid-2015.