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Company Seeks Approval of Extended-Release Hydrocodone With Abuse-Deterrent Properties

Trial data presented at pain society meeting

Purdue Pharma has filed a new drug application (NDA) with the FDA seeking authorization to market a once-daily, single-entity hydrocodone bitartrate tablet. The investigational pain medication was formulated to incorporate abuse-deterrent properties designed to make the drug more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting, and intravenous injection).

Data from clinical trials assessing the medication’s safety, efficacy, and abuse liability were presented April 30 at the 33rd Annual Scientific Meeting of the American Pain Society (APS) in Tampa, Florida.

A long-term study evaluated the safety of abuse-deterrant hydrocodone and the persistence of its analgesic effect in 922 opioid-naive and opioid-experienced subjects with moderate-to-severe chronic non-malignant and non-neuropathic pain. During maintenance treatment, persistent analgesia and improved function were achieved with stable doses of abuse-deterrent hydrocodone. The use of short-acting opioids was stable at a reduced level from baseline during the 52-week treatment period.

The intranasal abuse-deterrent properties of hydrocodone were evaluated in 31 healthy, non-dependent subjects with a history of recreational opioid drug use. The subjects received four intranasal treatments (coarse hydrocodone particles, fine hydrocodone particles, hydrocodone powder, and placebo) in a randomized, double-blind, crossover trial. A primary endpoint of the study was drug liking, measured up to 36 hours after dosing using a visual analogue scale (VAS). The results showed that tampered hydrocodone (coarse and fine particles) had a significantly lower intranasal abuse potential than had hydrocodone powder.

Compared with hydrocodone powder, 68% of subjects had a reduction of at least 30% in the maximum drug-liking score after using coarse hydrocodone, and 64% of subjects had a reduction of at least 50%. When fine hydrocodone was compared with hydrocodone powder, 72% of subjects had a reduction of at least 30% in the maximum drug-liking score, and 64% of subjects had a reduction of at least 50%.

In another study, the oral abuse-deterrent properties of hydrocodone were evaluated in 35 healthy, non-dependent recreational opioid drug users. The subjects received hydrocodone intact, hydrocodone chewed, hydrocodone milled, hydrocodone solution, and placebo in a randomized, double-blind, crossover trial. A primary endpoint of the study was drug liking, measured up to 36 hours after dosing using a VAS. The results showed that hydrocodone intact and hydrocodone chewed had significantly lower drug-liking scores than had hydrocodone solution.

Compared with hydrocodone solution, 83% of subjects had a reduction of at least 30% in the maximum drug-liking score after using intact hydrocodone, and 74% of subjects had a reduction of at least 50%. When chewed hydrocodone was compared with hydrocodone solution, 69% of subjects had a reduction of at least 30% in the maximum drug-liking score, and 60% of subjects had a reduction of at least 50%. When milled hydrocodone was compared with hydrocodone solution, 17% of subjects had a reduction of at least 30% in the maximum drug- liking score, and 9% percent of subjects had a reduction of at least 50%.

Hydrocodone products are the most commonly prescribed opioid analgesics in the U.S. They are also the most widely abused (nonmedical use), according to the Substance Abuse and Mental Health Services Administration. Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies.

Source: PipelineReview.com; April 30, 2014.

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