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Acura must provide FDA more info on pain drug

Regulator questions abuse-resistant ability of Aversion
FDA headquarters White Oak

The FDA has demanded that Acura Pharmaceuticals submit more evidence on the abuse-deterrent abilities of its investigational pain drug.

The request from the US regulator means that Acura may have to conduct an additional clinical study to demonstrate that its medicine – Aversion hydrocodone with acetaminophen – has a reduced risk of being abused by snorting.

“The FDA continues to question the relevance of abuse of hydrocodone with acetaminophen products by the intranasal route of administration and suggested additional information may help better inform their decision,” said Acura in a statement.

Acura is a company that specialises in developing medicines that deter or resists abuse and misuse. Its Aversion technology causes the drug to become a gel when it's dissolved, meaning it cannot be abused via injection – a feature the FDA accepts.

However, drugs with the Aversion technology are also meant to contain compounds that irritate the nasal passages, reducing the risk of abuse via snorting.

It's this method of deterrence the FDA has queried and Acura said it its now reviewing clinical data from its AP-ADF-301 study involving Aversion hydrocodone with acetaminophen to determine if plans to proceed with another trial.

To complicate the matter the FDA has already approved Acura's oxycodone HCl immediate-release tablets, which contain the Aversion technology.

Encouraging pain drugs that deter the risk of abuse has become an important issue for the FDA in recent years with Dr Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products at the FDA, describing the abuse of prescription drugs as a “public health crisis” in the US.

Other companies working on such similar products include Purdue, which last month received FDA approval for opioid-based pain treatment Targiniq ER, a combination of oxycodone hydrochloride and naloxone hydrochloride.

Article by
Thomas Meek

18th August 2014

From: Sales, Regulatory

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