CUPERTINO, Calif., Dec. 11 DURECT Corporation(Nasdaq: DRRX) today reported that Pain Therapeutics, Inc. (Nasdaq: PTIE) hasreceived a Complete Response Letter from the U.S. Food and Drug Administration(FDA) for its New Drug Application (NDA) for REMOXY(R), an abuse-resistantcontrolled-release form of oxycodone. Based on its review, the FDA hasdetermined 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 datawill be required to support the approval of REMOXY. The FDA has not requestedor recommended additional clinical efficacy studies prior to approval. PainTherapeutics, King Pharmaceuticals, Inc. and their outside technical advisorsare evaluating the FDA Complete Response Letter, will discuss the Letter withthe FDA, and will provide an update when appropriate. Pain Therapeutics andKing Pharmaceuticals remain diligently committed to their strategic allianceto develop and commercialize REMOXY and other abuse-resistant painmedications.
REMOXY is being developed by Pain Therapeutics under license from DURECT,and Pain Therapeutics has, in turn, sublicensed the commercialization rightsfor this drug candidate to King Pharmaceuticals. REMOXY, based on DURECT'sORADUR(TM) technology, is an investigational drug that is a unique,abuse-resistant, controlled release formulation of oxycodone formoderate-to-severe chronic pain.
About ORADUR(TM) Technology
ORADUR is a proprietary technology designed to transform short-acting oralcapsule dosage forms into sustained release oral products, with the addedbenefit of being less prone to abuse (e.g. by crushing or water extraction)than other controlled release dosage forms on the market today.
In December 2002, DURECT licensed to Pain Therapeutics, Inc. the right todevelop and commercialize on a worldwide basis REMOXY and other oral sustainedrelease drug candidates using the ORADUR technology which incorporate fourspecified opioid compounds. Under the license agreement, DURECT is reimbursedfor formulation and other work performed under its agreement with PainTherapeutics, and will receive additional payments if certain development andregulatory milestones are achieved with respect to the licensed drugcandidates. In addition, if commercialized, DURECT will receive royalties forREMOXY and the other licensed drug candidates of between 6.0% to 11.5% of netsales of the drug candidate depending on sales volume as well as a mark-up onDURECT's supply of key excipients used in the manufacture of the licensed drugcandidates. Pain Therapeutics sublicensed the commercialization rights ofREMOXY and other licensed drug candidates to King Pharmaceuticals in November2005.
About DURECT Corporation
DURECT is an emerging specialty pharmaceutical company developinginnovative drugs for pain and other chronic diseases, with late-stagedevelopment programs including REMOXY(R), POSIDUR(TM), ELADUR(TM), andTRANSDUR(TM)-Sufentanil. DURECT's proprietary oral, transdermal andinjectable depot delivery technologies enable new indications and superiorclinical/commercial attributes such as abuse deterrence, improved convenience,compliance, efficacy and safety for small molecule and biologic drugs. Formore information, please visit http://www.durect.com.
NOTE: POSIDUR(TM), SABER(TM), ORADUR(TM), TRANSDUR(TM), and ELADUR(TM) aretrademarks of DURECT Corporation. Other referenced trademarks belong to theirrespective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drugcandidates under development and have not been approved for commercializationby the US Food and Drug Administration or other health authorities.
DURECT Forward-Looking Statement
The statements in this press release regarding REMOXY its potentialattributes and statements related to plans by Pain Therapeutics and KingPharmaceuticals to discuss the Complete Response Letter with the FDA andprovide an update when appropriate are forward-looking statements involvingrisks and uncertainties that can cause actual results to differ materiallyfrom those in such forward-looking statements. Potential risks anduncertainties include, but are not limited to, the potential that FDA may notgrant regulatory approval of REMOXY, difficulties or delays in thedevelopment, testing, regulatory approval, production and commercialization ofREMOXY, and unexpected adverse side-effects or inadequate therapeutic efficacyof REMOXY that could slow or prevent product approval or market acceptance(including the risk that current and past results of clinical trials are notnecessarily indicative of future results of clinical trials). Furtherinformation regarding these and other risks is included in DURECT's Form 10-Qdated November 4, 2008 under the heading "Risk Factors."
SOURCE DURECT Corporation