May 10 Pain Therapeutics Inc said
Pfizer Inc, its marketing partner for painkiller Remoxy,
was yet to decide on continuing to seek regulatory approval for
Shares of Pain Therapeutics fell 20 percent in light trading
before the bell. Shares of Durect Corp, which provided
the technology used in Remoxy, fell about 13 percent.
Pfizer said it appeared there was a "regulatory pathway
forward" for the drug, which it discussed with the U.S. Food and
Drug Administration in a meeting on March 28.
However, Pfizer executive Alan Litwack said in a letter to
Pain Therapeutics Chief Executive Remi Barbier that "no final
decision has been made at this time" on whether to take Remoxy
to commercial development. ()
The abuse-resistant painkiller has been rejected twice by
the FDA due to concerns about its chemical make-up and
Pfizer said its response to the FDA's latest rejection
letter in June 2011 would not be submitted to the regulator
The company's shares were down slightly before the bells.
Shares of Pain Therapeutics and Durect Corp rose
more than 40 percent last week after Pfizer said it was in talks
with the FDA to find a way forward for Remoxy.
Durect's technology was used to design Remoxy as a gel
capsule so that it couldn't be abused by crushing it for
snorting or dissolving it for injecting.