FDA Panel Votes Against Acurox - Analyst Blog

The US Food and Drug Administration’s (FDA) advisory panel recently withheld the approval for opioid candidate, Acurox, used in treating moderate to severe pain.

 

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 candidate has been developed as per King Pharmaceuticals, Inc.’s (KG) agreement with Acura Pharmaceuticals, Inc. (ACUR) for the licensing, development, and commercialization of immediate release (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology.

 

The advisory panel’s opposition to the approval does not come as a surprise. Earlier in June 2009, King and Acura had received a complete response letter from the FDA regarding the New Drug Application (NDA) for Acurox. At that time, the FDA had raised issues regarding the potential abuse deterrent benefits of Acurox.

 

Although the agency did not ask for additional clinical studies, King and Acura were asked to submit the NDA to an FDA advisory committee which would review the evidence supporting the potential abuse deterrent effects of Acurox compared to other currently marketed short-acting oxycodone opioid products.

 

The committees were asked to discuss the results of studies evaluating the addition of niacin for the purpose of reducing the misuse of oxycodone. According to the companies, the addition of Niacin produces disliking effects when Acurox is taken in excess doses.

 

However, the committees said that there was not enough evidence to support Acurox’ approval. While the FDA is not required to follow the panel’s recommendation, it usually does so. Acura and King intend to work with the FDA to determine the next steps for gaining approval for Acurox.

 

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 King achieve a leading position in the abuse-deterrent opioid market.