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FDA Accepts Application for Extended-Release Oxycodone (Remoxy)

Approval decision set for September

The FDA has announced that the new drug application for Remoxy (Durect Corporation/Pain Therapeutics), an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review. September 25, 2016, is the target action date under the Prescription Drug User Fee Act (PDUFA).

Remoxy, an investigational drug, is a long-acting oral formulation of oxycodone intended to manage pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is designed to discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse. In particular, the thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting, or smoking.

A human abuse-potential study was conducted with Remoxy to assess its attractiveness among recreational opioid abusers. The study’s primary objective measured the abuse potential of chewed and intact Remoxy 40 mg compared with immediate-release (IR) oxycodone 40 mg.

The randomized, double-blind, placebo- and active-controlled study used a four-way crossover design in healthy, nondependent recreational opioid users. A naloxone challenge phase ensured that subjects were not opioid dependent, and a drug discrimination phase ensured that the subjects could discriminate between the subjective effects of IR oxycodone 20 mg, IR oxycodone 40 mg, and placebo. The subjects then received a single dose of study treatments, with a minimum five-day washout between crossovers. The subjects were instructed to chew the Remoxy capsules vigorously for up to five minutes.

Forty-six evaluable subjects completed the study. Pharmacodynamic measurements of the primary endpoints, Drug Liking and Drug High, included the use of a standard 0-to-100-point Visual Analogue Scale (VAS) during the initial two hours post-dose. Remoxy, both chewed and taken intact, met the study’s coprimary endpoints with statistical significance.

Opioid drugs, such as oxycodone, are an important treatment option for patients with severe chronic pain. However, oxycodone abuse and diversion remain serious, persistent problems. Nearly 19,000 people died from opioid overdose in the U.S. in 2014, according to the National Institute on Drug Abuse. Abuse-deterrent formulations are designed to make it difficult, longer, or aversive to tamper with long-acting opioid formulations, recognizing that no drug can be made entirely abuse-proof.

Sources: Durect Corporation; April 12, 2016; Journal of Pain; April 2016; and Pain Therapeutics; March 29, 2016.

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