FDA Advisory Committee Recommends Against Approving Abuse-Deterrent Pain Med
The FDA voted against recommendign oxycodone extended-release capsules (REMOXY ER, Pain Therapeutics) for approval for the management of pain severe enough to require long-term, around-the-clock opioid treatment, during a joint meeting of the agency’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), and the Drug Safety and Risk Management Advisory Committee (DSARM).
The FDA has recommended against 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, during recent a 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, FDA officials 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.
According to Pain Therapeutics, 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.
Overall, an FDA review found that oxycodone ER product use has gradually decreased in recent years. Among abuse-deterrent opioid analgesics, reformulated OxyContin accounted for the highest proportion of total prescriptions that were dispensed in 2017, the agency noted in a briefing for the joint AADPAC-DSARM meeting.
In a press release, Pain Therapeutics said studies about REMOXY ER were extensive, and clinical efficacy was established in a phase 3 study. More than 2,400 individuals who participated in the study were exposed to the drug in 30 clinical studies, and 9,000 data points were generated from 11 laboratory studies. REMOXY ER’s abuse deterrence is supported by data from laboratory, pharmacokinetic, and human abuse potential studies.
REMOXY ER is comprised of a thick, sticky, high viscosity, hydrophobic, gel formulation that individuals with substance use disorder cannot cut, grate, or divide into smaller particle sizes. The formulation resists syringe-ability, injection, and rapid extraction in ingestible solvents, according to the Pain Therapeutics press release.
The company is requesting marketing approval for REMOXY ER as an analgesic medication with properties that can be expected to deter individuals from injecting, snorting, and inhaling or smoking it.
Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for REMOXY ER [news release]. Austin, TX: June 26, 2018; Pain Therapeutics. https://globenewswire.com/news-release/2018/06/26/1530002/0/en/Pain-Therapeutics-Announces-Results-of-FDA-Advisory-Committee-Meeting-for-REMOXY-ER.html. Accessed June 27, 2018.
FDA. FDA Briefing Document: Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. 2018:42-51. FDA website.