The Food and Drug Administration (FDA)’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted against (14-3) the approval of Remoxy ER (oxycodone extended-release capsules; Pain Therapeutics) for the management of severe pain that requires daily, around-the-clock, long-term opioid treatment and for which alternative options are inadequate.
Remoxy ER contains oxycodone, a full opioid agonist, and utilizes the Company’s ORADUR technology which is designed to deter abuse via non-oral routes. In 2016, Pain Therapeutics received a Complete Response Letter (CRL) from the FDA stating that the New Drug Application (NDA) for Remoxy ER could not be approved in its present form and that the Company needed to conduct additional studies to substantiate the claims regarding three routes of abuse (i.e., injection, inhalation and snorting). This additional study data was included in the Committees’ most recent review.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date for August 7, 2018. The Agency is not bound by the Committees’ recommendation but takes them into consideration when conducting its review.
For more information visit PainTrials.com.