King Pharmaceuticals, Inc. (KG) and Acura Pharmaceuticals, Inc. (ACUR) recently met with the U.S. Food and Drug Administration (FDA) to discuss the agency’s response to the New Drug Application (NDA) for Acurox (oxycodone HCl and niacin).

The companies and the agency agreed that the NDA should be reviewed by an FDA advisory committee. The agency has not asked the companies to conduct additional clinical trials.

Acurox is an orally administered immediate release tablet containing oxycodone HCl as an active analgesic ingredient, niacin as an active ingredient in subtherapeutic amounts, and a unique combination of other ingredients. King and Acura are looking to gain approval of Acurox for the relief of moderate-to-severe pain. Acurox is also designed to discourage some common methods of misuse and abuse.

In its complete response letter, which was issued in July 2009, the FDA had raised issues regarding the potential abuse deterrent benefits of the drug. Therefore, we were not surprised to hear that the candidate’s potential opioid abuse deterrent effects will be reviewed by the advisory panel. While the FDA has yet to establish a date for the advisory panel meeting, we do not expect the same to take place until later this year.

Besides Acurox, King faced a regulatory setback with another opioid candidate, Remoxy, which failed to receive approval late in December 2008. King expects to resubmit its NDA for Remoxy in mid-2010. King has an agreement with Pain Therapeutics (PTIE) for the development and commercialization of Remoxy, which has been developed using Durect Corp.’s (DRRX) ORADUR technology.

We were initially expecting both Remoxy and Acurox to start contributing to the top-line from 2010. However, given the regulatory setbacks, we do not expect the products to hit the market before 2011. According to the company, the combined market opportunity for Remoxy and Acurox could exceed $700 million.

We currently have an Underperform rating on King. While the company got good news recently with the approval of Embeda, we remain concerned about the declining prescription trends for key products and the possibility of Skelaxin facing generics later this year.

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