CUPERTINO, Calif., June 10 DURECT Corporation(Nasdaq: DRRX) announced today that a New Drug Application (NDA) forRemoxy(TM) (ORADUR(TM)-based oxycodone) has been submitted to the U.S. Foodand Drug Administration (FDA). Remoxy, an investigational drug, is a longacting oral formulation of oxycodone intended to treat moderate to severepain. Based on DURECT's ORADUR technology, Remoxy is designed to resistcommon methods of prescription drug misuse and abuse.
"We are pleased that the first NDA has been filed for a drug candidateusing one of DURECT's platform technologies," stated James E. Brown, DVM,President and CEO of DURECT. "The abuse of pain medications is a widespreadproblem in this country and addressing that issue is clearly in the publicinterest. We designed our ORADUR technology to enable the abuse resistantproperties of drug candidates such as Remoxy which has the potential to be thefirst oxycodone on the market that deters common methods of abuse."
Remoxy is being developed by Pain Therapeutics under license from DURECT,and Pain Therapeutics has, in turn, sublicensed the commercialization rightsto the drug candidate to King Pharmaceuticals. King and Pain Therapeuticshave stated that they believe the NDA for Remoxy benefits from years ofrigorous and independent scientific and clinical testing, and the NDA includesanimal and human data from extractability, pharmacokinetic, toxicology andclinical studies.
About the NDA for Remoxy (as announced by King and Pain Therapeutics)
Pain Therapeutics submitted the NDA in accordance with the FDA'sElectronic Common Technical Document specifications. Pursuant to PrescriptionDrug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whetherto accept the NDA for filing within 90 days. At that time Pain Therapeuticswill also learn if the NDA filing was granted priority review. A PriorityReview designation is given to drugs that offer real advances in treatment, orprovide a treatment where no adequate therapy exists. A Priority Review meansthat the time it takes FDA to review a NDA is reduced from 12 months toapproximately 6 months.
About the Development Program for Remoxy (as announced by King and PainTherapeutics)
The development program for Remoxy consisted of several clinical studies,including one pivotal Phase III study conducted under a Special ProtocolAssessment (SPA), which evaluated the safety and efficacy of Remoxy in over400 patients with osteoarthritis. With a SPA, the study design, endpoints andstatistical analyses needed to support approval were agreed upon by the FDAprior to initiating the study and are considered binding. Pain Therapeuticsand King have stated that they believe that the SPA for Remoxy remains infull-force without modification. The following summarizes the pivotal PhaseIII results:
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration's website for moreinformation:http://www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm
About Chronic Pain
Approximately 50 million Americans suffer with chronic pain, a distincttype of pain, often with no cure. It can affect an individual throughout hisor her life, lasting several weeks, months, or even years at a time. Theonset of chronic pain may be nociceptive (caused by ongoing tissue injury),neuropathic (caused by damage to the brain, spinal cord, or peripheralnerves), or disease specific (such as osteoarthritis or cancer).
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, D