Acura Pharmaceuticals Inc. and King Pharmaceuticals Inc. said Monday the potential abuse-resistant painkiller Acurox met key goals in a pivotal study.
The companies said the drug candidate met all five key goals of abuse-resistance, compared with equivalent doses of oxycodone HCI.
Acurox contains oxycodone, a morphine derivative that is the active ingredient in the drug OxyContin. The drug includes features developed by Acura that will prevent abuse, the companies say. The FDA declined to approve the drug in June 2009, saying it had concerns about the abuse deterrent benefits.
The FDA and the company have agreed that data and studies supporting the drug would be presented to an FDA advisory committee, though the timing of that meeting has not been confirmed. The company was not required to conduct an additional study, but said it conducted the most recent study to provide additional supporting evidence.
Acura's Aversion Technology is intended to discourage people from getting high by overdosing on Acurox, or by crushing the pills and snorting them, or dissolving and injecting them. If the drug is exposed to water or alcohol, Acura says, the oxycodone gets trapped in a gel mixture, which makes it difficult to get into a needle. If snorted, it creates a burning, irritating sensation in the nose, and because the drug also contains niacin, excess doses cause symptoms such as warmth or flushing, itching, sweating, chills, headache and discomfort.
Shares of Acura, based in Palatine, Ill., rose 9 cents to $5 in after-hours trading, after rising 10 cents, or 2.1 percent, to close at $4.91 during the regular trading session.
Shares of King Pharmaceuticals, based in Bristol, Tenn., fell 7 cents to close at $12.11.