FDA Requests Additional Info On Acura's Aversion Hydrocodone Treatment

Acura Pharmaceuticals announced in a press release that it had met with the Food and Drug Administration (FDA) to discuss its Aversion hydrocodone with acetaminophen tablet. The meeting came after the FDA’s May 2014 letter to Acura regarding the agency’s reservations about the product’s abuse deterrent features. The FDA has accepted Acura’s Aversion technology that guards against injection but questions whether the product will avert intranasal abuse. Acura stated that the FDA is deliberating further but that the agency suggested an additional nasal abuse liability study may help inform its decision.

Aversion Technology

Acura’s Aversion technology is a patent protected formulation of oxycodone, which the FDA approved in 2011. The Schedule II narcotic treats moderate to severe pain. The drug was developed with King Pharmaceuticals and licensed to Pfizer in 2010.

In April 2014, Acura announced that it had terminated Pfizer’s license for a payout of $2 million.

The technology works by including non-active ingredients that transform the drug in an abusive situation. If a user dissolves the tablet to inject it, the agent becomes a gel, unable to be injected. If the user crushes the tablet to snort it, the inactive ingredients create an irritant in the nose.

FDA Action

The FDA has indicated that the injection abuse features are acceptable but the nasal abuse formulation is unclear. The FDA suggested that an additional study of nasal abuse may answer some of the agency’s questions about abuse-deterrence as well as offer more data regarding the user’s “liking” of the drug. The FDA states that neither issue was statistically significant in an earlier study, Study 301. The FDA is especially interested in the "drug liking" aspect of abuse deterrence, also known as known as Emax.

Study 301

Study 301, titled, “Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users,” was a phase II assessment of intranasal abuse. Patients with a history of snorting opioids participated and researchers evaluated their Aversion Emax scores compared to a placebo and control drugs. The FDA has indicated that the results were not distinguished enough for the agency to move forward.

If Acura seeks another trial to prove to the FDA that Aversion is abuse-deterrent, it may seek further guidance from the FDA or the European Medicines Agency (EMA) for trial design. The company may also seek assistance from a contract research organization (CRO) or develop a partnership with another company.