Remoxy Review Shows How Opana ER Experience Changed US FDA Thinking On New Opioid Formulations
Pain Therapeutics CEO Barbier says comparing Remoxy to Endo's withdrawn Opana ER 'borders on slanderous' and asserts that after three complete response letters, FDA is once again moving goalposts for approval.
You may also be interested in...
Intellipharmaceutics’ Oxycodone ER Returns To US FDA Panel Looking For Abuse-Deterrence Claim
Although abuse by intravenous route is expected to be deterred compared to immediate-release oxycodone, neither nasal nor oral abuse deterrence was demonstrated in two new human abuse potential studies, agency concludes; product has a new formulation and a new name, Aximris XR, since a 2017 AdComm.
Pain Therapeutics Appeals Remoxy CRL In Likely Last Ditch Effort To Save Abuse-Deterrent Opioid
Meeting with US FDA in January will aim to reverse fourth rejection in 10 years; firm still criticizing agency even as it works to reconcile their positions.
Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue
Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.