Acurox Under Fire At FDA Panel

A joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Committee began at 8:00 a.m. EST on Thursday to discuss the fate of Acurox. The drug is a combination of oxycodone (the generic name of Purdue Pharma's OxyContin) and niacin, and will be jointly marketed by

Acura Pharmaceuticals (ACUR) and

King Pharmaceuticals (KG). Acurox is intended to treat moderate-to-severe pain, but is meant to be abuse-deterrent, meaning it can't be easily crushed or dissolved in liquid.

(See

The Tricky Business of Perfecting Pain Meds .)

The companies submitted the New Drug Application in March 2009, but hit a snag when they received a Complete Response Letter last July. The FDA has qualms about calling the pill "abuse-deterrent," because the affects of the niacin can be overcome by eating a high-fat meal or taking aspirin. Even though the niacin isn't completely abuse-deterrent when it's swallowed, the drug causes uncomfortable flushing when taken beyond the recommended dose. Acurox also has ingredients that cause burning in the nasal cavity should users try to crush and snort the pill. It also turns to a gel-like substance when users try to dilute it in liquid to inject it.

Beyond the concern that the niacin doesn't really prevent the abuse of the painkiller, the FDA is worried about how the side effects of the niacin will affect patients who are actually using the drug properly. Studies showed that the uncomfortable flushing -- which included itching, redness, tingling, skin warmth, and burning -- was shown to affect patients properly using the drug.

In briefing documents released Tuesday, the advisory panel questioned "what constitutes an adequate degree of 'abuse-deterrence' to warrant description in the product's label." This is a huge distinction because Acurox has no place in the market if it's not considered abuse-deterrent. The market is already dominated by Purdue's OxyContin -- a drug that physicians have depended on for years despite the potential for abuse. Acurox will also likely be priced higher because of the niacin component -- another drawback in the eyes of doctors.

Earlier this year, the FDA approved a new version of Purdue Pharma's OxyContin that is "designed to help discourage abuse." Unlike Acurox, OxyContin is extended-release, while Acurox is an instant-release painkiller.

If Acurox passes the panels' muster and makes it to market after the FDA decision, the drug will just be one of many in the very lucrative pain-management market -- the market was worth $18.3 billion in 2009 and is expected to grow to $22.6 billion by 2016. Not only will Acurox be competing with OxyContin, but King's other "abuse-deterrent" drugs like Remoxy -- which King is also trying to get FDA approval for.

Source : http://www.minyanville.com/businessmarkets/articles/acura-pharmaceuticals-complete-response-letter-fda/4/22/2010/id/27925

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