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FDA issues complete response letter for King, Acura's pain drug candidate Acurox
Thursday, July 02 2009 | Comments
What's This?
The Food and Drug Administration sent a complete response letter to King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc. pertaining to the companies' New Drug Application for Acurox (oxycodone hydrochloride/niacin), which is being reviewed for the relief of moderate to severe pain.The opioid analgesic employs Acura's abuse-deterrent technology, and the companies said the agency raised issues relating to the potential abuse-deterrent benefits of the drug, although they did not specify details. Acura previously indicated that when dissolved in water or other common solvents, the tablets form a gelatinous mass, making it more difficult for the oxycodone to be chemically extracted and creating a physical impediment to drawing the dissolved drug into a syringe.
King and Acura said at this stage of their review, they believe a response to the FDA's complete response letter can be made without conducting additional studies.
As previously reported, Acura entered into a license, development and commercialization agreement with King to produce a potentially wide range of opioid analgesic products using Acura's Aversion abuse-deterrent technology platform. Under the agreement, King gained an exclusive license to Acurox in the United States, Canada and Mexico.
In addition to collaborating on Acurox, the companies are developing three additional opioid analgesic product candidates utilizing Acura's Aversion technology.
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