Never Surrender: Pain Therapeutics Eyes 2016 Remoxy Filing
This article was originally published in The Pink Sheet Daily
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...
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.
The latest drug development news and highlights from our FDA Performance Tracker.
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.