CRL for Pfizer/Pain's Remoxy

The US Food and Drug Administration recently dealt a blow to Pfizer (PFE - Analyst Report) and Pain Therapeutics, Inc. (PTIE - Snapshot Report) by issuing a second complete response letter (CRL) for their opioid candidate, Remoxy.

Remoxy became a part of Pfizer’s pipeline following its acquisition of King Pharmaceuticals earlier this year. Remoxy 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.

The CRL is a major setback for Pain Therapeutics and Durect Corp. While Pain Therapeutics’ shares dropped more than 40% on the news, Durect’s shares were down 31%.

Second CRL for Remoxy

Remoxy’s regulatory path has not been smooth with the candidate receiving a second CRL from the FDA. King Pharma had initially submitted the Remoxy new drug application (NDA) in June 2008. However, in late Dec 2008, the FDA issued a CRL for Remoxy asking for additional information. As part of the resubmission plan, and in order to strengthen the NDA, King Pharma had conducted a likeability study and a pharmacokinetic trial in volunteers. The NDA was re-submitted in Dec 2010.

While Pfizer and Pain Therapeutics did not provide any details regarding the issues raised in the second CRL, we note that on its first quarter conference call, Pfizer had said that there could be a delay in the timing of the approval or launch of Remoxy. At that time, the company had said that it is working on addressing a specific issue in the manufacturing section of the application for Remoxy. The company also said that it is evaluating the impact of the FDA’s announcement regarding a class-wide Risk Evaluation and Mitigation Strategies (REMS) proposal for extended-release opioids.

Currently, we have low visibility on the FDA’s requirements for granting approval to Remoxy. Pfizer intends to meet with the agency to discuss the issues raised in the CRL.

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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