Pain Therapeutics Receives Complete Response Letter From FDA For REMOXY(R)

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Pain Therapeutics Receives Complete Response Letter From FDA For

REMOXY®

http://www.medicalnewstoday.com/articles/132740.php

DURECT Corporation (Nasdaq: DRRX) reported that Pain Therapeutics,

Inc. (Nasdaq: PTIE) has received a Complete Response Letter from the

U.S. Food and Drug Administration (FDA) for its New Drug Application

(NDA) for REMOXY®, an abuse-resistant controlled-release form of

oxycodone. Based on its review, the FDA has determined that the NDA

is not approved in its present form.

According to King Pharmaceuticals, Inc. (NYSE: KG), Pain

Therapeutics' commercial partner for REMOXY, the FDA believes

additional non-clinical data will be required to support the approval

of REMOXY. The FDA has not requested or recommended additional

clinical efficacy studies prior to approval. Pain Therapeutics, King

Pharmaceuticals, Inc. and their outside technical advisors are

evaluating the FDA Complete Response Letter, will discuss the Letter

with the FDA, and will provide an update when appropriate. Pain

Therapeutics and King Pharmaceuticals remain diligently committed to

their strategic alliance to develop and commercialize REMOXY and

other abuse-resistant pain medications.

REMOXY is being developed by Pain Therapeutics under license from

DURECT, and Pain Therapeutics has, in turn, sublicensed the

commercialization rights for this drug candidate to King

Pharmaceuticals. REMOXY, based on DURECT's ORADUR technology, is

an investigational drug that is a unique, abuse-resistant, controlled

release formulation of oxycodone for moderate-to-severe chronic pain.