FDA Approves Pfizer/Acura's Oxecta

Pfizer Inc. (PFE - Analyst Report) and partner Acura Pharmaceuticals Inc. (ACUR) recently received US Food and Drug Administration (FDA) approval for their pain treatment, Oxecta (oxycodone). Oxecta (formerly known as Acurox) gained approval for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

Oxecta became a part of Pfizer’s portfolio following its acquisition of King Pharma earlier this year. Oxecta has been developed under an agreement for the licensing, development, and commercialization of immediate release (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology.

The abuse-deterrent technology has been designed to discourage opioid abuse and misuse through common ways of tampering. Oxecta’s approval triggers a $20 million milestone payment to Acura from Pfizer.

Remoxy Action Date Round the Corner

Pfizer has another important FDA action date coming up with the agency expected to deliver a decision on pain candidate Remoxy this week. Remoxy, which is partnered with Pain Therapeutics, Inc. (PTIE - Snapshot Report), has been developed using Durect Corporation’s (DRRX - Snapshot Report) ORADUR technology, for moderate to severe pain that requires continuous, around-the-clock opioid treatment for an extended period of time.

Remoxy also became a part of Pfizer’s portfolio following its acquisition of King Pharma. Remoxy, which failed to gain first-round approval is currently under FDA review. While we believe that Remoxy will eventually receive approval given the need for abuse-deterrent products in the pain management market, Pfizer could face another delay in gaining approval for the candidate. Pfizer had previously announced that it is working on addressing a specific issue in the manufacturing section of the application for Remoxy. The company is also evaluating the impact of the FDA’s announcement regarding a class-wide Risk Evaluation and Mitigation Strategies (REMS) proposal for extended-release opioids.

Neutral on Pfizer

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). 2011 should be a catalyst-filled year for the company, which is expecting to present phase III data on several candidates. However, Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor in November.

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