If approved, REMOXY ER will be classified as a schedule II drug and would be subject to strict prescribing and dispensing rules.
In a joint meeting with the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA), Pain Therapeutics reported that the committee voted 14 to 3 against the approval of oxycodone extended-release capsules (REMOXY ER) for the management of pain severe enough to require daily, long-term opioid treatment for which alternative treatment options are insufficient.
The investigational drug is in registration with the FDA as a new type of abuse-deterrent, twice-daily capsule gel formulation of oral oxycodone. REMOXY ER was specifically developed to deter oxycodone abuse, providing 12 hours of pain relief.
With the thick, sticky, high viscosity, hydrophobic, gel formulation, abusers cannot cut, grate or divide REMOXY ER into smaller discrete particle sizes. The gel formulation resists syringe-ability, injection and rapid extraction in ingestible solvents, and resists dose-dumping when challenged by alcohol and common physical and chemical manipulations. When exposed to heat, REMOXY ER releases an irritant to the eyes and lungs.
Clinical efficacy was established in a phase 3 study, conducted under a special protocol assessment, where more than 2400 subjects were exposed to REMOXY ER in 30 clinical studies. Researchers generated 9000 unique data points from 11 lab studies.
The assessment of the drug’s abuse deterrence is supported by data from FDA category 1 (lab), category 2 (pharmacokinetic) and category 3 (human abuse potential) studies.
“REMOXY ER intends to address the public health epidemic related to prescription opioids by advancing the science of abuse deterrence, providing an additional treatment option for physicians and patients, and increasing the range of available abuse deterrent technologies,” Pain Therapeutics wrote in a statement.
The prescription drug user fee act (PDUFA) date is set for Aug. 7, 2018, and if approved, REMOXY ER will be classified as a schedule II drug and would be subject to strict prescribing and dispensing rules.