FDA Approves Abuse-Deterring Opioid, Hysingla ER

The FDA announced its approval of Hysingla ER (hydrocodone bitartrate), an extended release analgesic meant for long-term treatment of severe pain. Purdue Pharma will release the drug with language outlining its abuse-deterrent properties, which is consistent with the FDA’s 2013 guidance.

The CDC reports that instances of prescription drug overdose-related deaths have tripled since 1990, and prescription drug abuse outstrips both cocaine and heroin abuse combined. Opioids head the CDC’s list of popular abused drugs.

These concerns have prompted many companies to pursue abuse-deterrent versions of painkillers. The FDA released a guidance last year which outlined how these properties might be assessed and proven during clinical trials.

The ways in which Hysingla deters abuse are both physical and chemical. The pill was deliberately manufactured in ways that discouraged its break down and use as an injectable.

David Haddox, Purdue Pharma’s chief of health policy told The New York Times (NYT) that the pills were extra dense, which discouraged the crushing necessary for snorting, and the pills turn into a “gelatinous, gooey mass that doesn’t pull into a syringe easily” when the drug is mixed with fluids.

There are some who criticize the FDA’s move and wish Hysingla had been subjected to additional scrutiny.

NYT spoke to Andrew Kolodny, CMO at Phoenix House, a group of non-profit addiction treatment centers. According to Kolodny, the new drug “packs an enormous amount of hydrocodone,” and addicts he knew would be capable of breaking down the pill for oral use.

Jane Woodcock, director of the FDA’s Center for Drug Evaluation and Research, admitted that the science of abuse-deterrents was not exact, but while it was “still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.”

The labeling of Hysingla reflects that the drug is not without risk. It is only recommended for patients for whom other alternatives have been exhausted. Patients should be educated on its proper use, and the FDA is requiring further post-market studies to follow up on the long-term efficacy of the abuse-deterrent properties.

According to a PRNewswire report, public pressure and interest in developing these products with abuse-deterrent properties is likely to produce a spike in growth in this area of research and development. Technology Catalysts International predicts that the desire for new abuse-deterring formulations will drastically affect the painkiller market.

PRNewswire reports that the current U.S. market for abuse-deterrent painkillers is currently $4 billion and is expected to grow.