US FDA accepts Remoxy NDA with PDUFA goal date of June 23, 2011

Cupertino, CaliforniaSaturday, January 29, 2011, 14:00 Hrs  [IST]

Durect Corporation reported that the US Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for Remoxy by King Pharmaceuticals, Inc. and the PDUFA goal date is June 23, 2011.

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.

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.

In December 2002, Durect licensed to Pain Therapeutics, Inc. the right to develop and commercialize on a worldwide basis Remoxy and other oral sustained release drug candidates using the Oradur technology which incorporate four specified opioid compounds. Under the license agreement, Durect is reimbursed for formulation and other work performed under its agreement, and will receive additional payments if certain development and regulatory milestones are achieved with respect to the licensed drug candidates.

In addition, if commercialized, Durect will receive royalties for Remoxy and the other licensed drug candidates of between 6.0% to 11.5% of net sales of the drug candidate depending on sales volume as well as a mark-up on Durect's supply of key excipients used in the manufacture of the licensed drug candidates. Pain Therapeutics sublicensed the commercialization rights of Remoxy and other licensed drug candidates to King Pharmaceuticals in November 2005. In October 2010, Pfizer Inc. announced that it had entered into a definitive merger agreement to acquire King. Should that transaction be completed, Pfizer would assume the development and commercialization rights and obligations to Remoxy and to the other licensed Oradur-based opioids.

Durect is a specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including Remoxy, Posidur, Eladur, and Transdur-Sufentanil. DURECT's proprietary oral, transdermal and injectable depot delivery technologies may enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs.