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Acura Pharma and FDA Discuss Anti-Abuse Pain Pill

Mon, 12/09/2013 - 3:08pm

WASHINGTON (AP) — Shares of Acura Pharmaceuticals Inc. rose Monday after the company said it met with federal regulators to discuss a new version of the painkiller hydrocodone that uses the company's abuse-resistant technology.

Acura said the meeting with the Food and Drug Administration focused on a mid-stage study of a mixture of hydrocodone and acetaminophen that is designed to be harder to abuse. Hydrocodone is the narcotic ingredient in drug tablets like Vicodin, which abusers often crush and snort to achieve a euphoric high.

Acura said the FDA agreed to review the study and determine whether it could be used to support a new drug application. The FDA uses such applications to review the safety and effectiveness of experimental drugs.

Company executives said they would provide an updated timeline on development of the proposed drug after they receive a formal response from the FDA.

Palatine, Ill.-based Acura makes drugs that are formulated to discourage abuse. The company sells a decongestant called Nexafed and its abuse-deterring technology is used in Pfizer Inc.'s painkiller Oxecta.

Oxecta is an immediate-release drug that contains oxycodone, the active ingredient in OxyContin. It uses Acura's Aversion technology to discourage abuse: if the drug is exposed to water or alcohol, the oxycodone becomes trapped in a gel mixture, making it difficult to get into a needle. If inhaled, it creates a burning, irritating sensation in the nose.

Nexafed contains pseudoephedrine, an ingredient in crystal meth. Acura says the drug contains inactive ingredients that turn into a thick gel if anyone tries to extract the pseudoephedrine. That means the chemical won't crystallize and can't be made into crystal meth.

Shares of Acura Pharmaceuticals rose 2 cents, or 1.42 percent, to $1.71 in trading Monday.

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