CUPERTINO, Calif., June 24, 2011 /PRNewswire/ — DURECT
Corporation (Nasdaq:
DRRX) today reported that Pfizer Inc. (NYSE:
PFE) has received a Complete Response Letter from the U.S. Food
and Drug Administration (FDA) for its New Drug Application (NDA)
for REMOXY®, a controlled-release form of oxycodone designed to
discourage common methods of tampering. Pfizer stated that it
is working to evaluate the issues described in the Complete
Response Letter and plans to have further discussions with FDA
around them.
(Logo: http://photos.prnewswire.com/prnh/20020717/DRRXLOGO)
“Pfizer has an experienced team of scientists dedicated to
resolving the remaining issues,” stated James E. Brown, D.V.M.,
President and CEO of DURECT Corporation. “The misuse and
abuse of pain medications is a widespread problem in this country
and we will continue to support Pfizer in their efforts to address
this important public health and safety issue.”
REMOXY, based on DURECT’s ORADUR® technology, is an
investigational drug that is a unique, controlled release
formulation of oxycodone for moderate-to-severe chronic pain
designed to reduce potential risks of unintended use.
Approximately 50 million Americans suffer from persistent
pain each year, according to the American Pain Foundation.
About ORADUR® Technology
ORADUR is a proprietary technology designed to transform
short-acting oral capsule dosage forms into sustained release oral
products, with the added benefit of resisting common methods of
prescription drug misuse and abuse compared to other controlled
release dosage forms on the market today.
Corporate Relationships
In December 2002, DURECT licensed to Pain Therapeutic
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