King Pharmaceuticals, Inc. (KG) and Acura Pharmaceuticals, Inc. (ACUR) recently announced that the FDA has established a date for an advisory committee meeting which will discuss the new drug application for Acurox. The committee will also discuss the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone.
The meeting, scheduled to take place on April 22, will be a joint meeting of the Anesthetic and Life Support Drugs and the Drug Safety and Risk Management Advisory Committees.
Acurox is an orally administered tablet containing oxycodone HCl as an active analgesic ingredient, niacin as an active ingredient in subtherapeutic amounts, and a unique combination of other ingredients.
The drug has been developed under King’s agreement with Acura Pharmaceuticals for the licensing, development, and commercialization of immediate release pain medicines utilizing Acura’s Aversion (abuse-deterrent) technology.
In June 2009, King and Acura received a complete response letter from the FDA regarding the New Drug Application for Acurox for the relief of moderate to severe pain. The FDA raised issues regarding the potential abuse deterrent benefits of Acurox.
Although the agency did not ask for additional clinical studies to be conducted, King and Acura were asked to submit the New Drug Application to an FDA advisory committee. A favorable recommendation from the advisory committee would be a major boost for King.
We currently have a Neutral recommendation on King. While declining prescription trends of key products and regulatory delays in receiving approval for new products remain a matter of concern, we view the recent launch of Embeda as a major milestone for the company. Embeda represents significant growth potential and could help the company achieve a leading position in the abuse-deterrent opioid market.
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