FDA Panel Votes Against Approval of Oxycodone ER Capsules for Pain Management

The FDA has recommended against the approval of oxycodone extended-release capsules (REMOXY ER, Pain Therapeutics) for the management of pain severe enough to require long-term, around-the-clock opioid treatment. The recommendation was made during a recent joint meeting of the agency's

Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and the Drug Safety and Risk Management Advisory Committee (DSARM).

According to Pain Therapeutics, the FDA Advisory Committee voted 14-3 against recommending the drug, and instead scheduled a Prescription Drug User Fee Act target action date (August, 7, 2018) for completion of its review of the New Drug Application for REMOXY ER.

REMOXY ER is an abuse-deterrent, oral formulation of the widely prescribed opioid medication oxycodone. The drug is intended to be used daily when there is not an adequate alternative treatment.

According the FDA, the number of prescriptions in outpatient retail pharmacy settings dispensed for oxycodone ER products decreased 31% between 2013 and 2017, from approximately 4.9 million to 3.4 million prescriptions, respectively. Prescriptions for single-ingredient oxycodone ER, and extended-release/long-acting opioid analgesic products, also decreased during the 2013-2017 period, 7% and 19%, respectively.

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