Now Who Needs a Painkiller? King and Pain Therapeutics Face a Remoxy Setback
This article was originally published in The Pink Sheet Daily
Executive SummaryA 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...
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.
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.
Extended-release oxycodone product has potential for broader abuse-deterrent claims than OxyContin; Pfizer expects to resubmit Remoxy to FDA by mid-2015.