Zacks_Analysts' Blog : Positive Data on Acurox Study - Analyst Blog

King Pharmaceuticals, Inc. (KG) and Acura Pharmaceuticals, Inc. (ACUR) recently presented positive top-line data on opioid candidate Acurox from a study that was conducted to assess the relative abuse potential of the drug.

Results from Study AP-ADF-114 (A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users) showed that Acurox was significantly disliked compared to oxycodone HCl tablets alone when excess doses are swallowed. All five co-primary endpoints of the study were achieved.

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 (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology.

Acurox has yet to gain approval from the US Food and Drug Administration (FDA) for the relief of moderate to severe pain. In June 2009, King and Acura received a "complete response letter" from the FDA regarding the New Drug Application (NDA) for Acurox. 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 NDA to an FDA advisory committee which will review the evidence to support the potential abuse deterrent effects of Acurox compared to other currently marketed short-acting oxycodone opioid products. A date for the advisory committee meeting has yet to be announced.

King and Acura intend to submit data from Study 114 as well to the advisory committee. A favorable recommendation 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.