- Pfizer has decided to not move forward with a deal with Pain Therapeutics to develop and commercialize an extended-release formulation of oxycodone. Pain Therapeutics' stock was down 50% on the news.
- Pfizer made the decision after an internal review in which it looked at FDA requests in a complete response letter (CRL) related to the development of this extended-release pain product.
- The response from the management of Pain Therapeutics has been positive and optimistic. They will regain full rights and continue development of the drug, Remoxy, which is in phase III.
Pfizer's top-line review looked at the data from five clinical trial completed to address the FDA's CRL, which was sent in June 2011. Development in the pain space is challenging when oxycodone is involved, because of the well-publicized hurdles related to addiction and abuse.
For its part, Pain Therapeutics intends to continue development on the drug and has announced that it is open to discussions with other potential pharmaceutical partners.