Pfizer and Pain Therapeutics' pain killer rejected by FDA Print E-mail
By Olivia D'Orazio -   
Friday, 24 June 2011 16:48
Pfizer (NYSE:PFE) and Pain Therapeutics (NASDAQ:PTIE) announced Friday their investigational Remoxy pain killer failed to receive approval from the U.S. FDA, sending shares of both companies down.

The two drug developers, who received a complete response letter outlining Remoxy's reasons for failure, saw their stocks slip 1.74% and a whopping 39.83%, to trade at $20.29 and $5.56, respectively.

The companies said they will continue conversations with the FDA to address the issues.

Remoxy is an extended-release opiod, or opium, pain killer, designed to treat moderate to severe chronic pain. Originally developed by Pain Therapeutics, the drug was developed to discourage misuse and abuse of the opium drug through the use of a technology called Oradur, developed by  DURECT Corp (NASDAQ:DRRX), whose stock also sunk 35.6% to $1.99 per share as of Friday afternoon.

"Pfizer is working to understand and address the issues in the FDA Complete Response Letter,” said Pfizer president and general manager of primary care, Olivier Brandicourt.

"We share the concern about misuse and abuse of opioid medicines and are committed to being part of the solution to address this important public health and safety issue."
In 2005, Pain Therapeutics entered into a $400 million agreement with Tennessee-based King Therapeutics to develop and commercialize Remoxy. In 2008, the companies filed for approval with the FDA for the first time, but were unsuccessful, as the agency requested more data.

King then resubmitted it to the FDA in December 2010, following an "abuse liability study", which met all primary goals. In February this year, Pfizer acquired King in a $3.6 billion deal, including the rights to Remoxy.

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