Severe Chronic Pain - Remoxy(TM) (ORADUR-based Oxycodone) Receives Special Proto

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Severe Chronic Pain - Remoxy (ORADUR-based Oxycodone) Receives

Special Protocol Assessment And Commences Pivotal Phase III

http://www.medicalnewstoday.com/medicalnews.php?newsid=37991

Durect Corporation (Nasdaq: DRRX) reported today that Remoxy, an

abuse-resistant pain medicine under development based on DURECT's

patented ORADUR technology incorporating the opioid oxycodone has

successfully completed a Special Protocol Assessment with the U.S.

Food and Drug Administration (FDA) and that a pivotal Phase III trial

is being commenced on Remoxy in 400 patients with severe chronic

pain. The events were announced on February 16 by King

Pharmaceuticals, Inc. (NYSE: KG), the company which will be

commercializing Remoxy, if approved, and Pain Therapeutics, Inc.

(Nasdaq: PTIE), Durect 's licensee of the rights to Remoxy and other

ORADUR-based products incorporating oxycodone and three other opioid

compounds.

" We are very pleased with development progress of Remoxy and the

clarification of the pathway to regulatory approval afforded by the

Special Protocol Assessment, " said Jim Brown, D.V.M., President & CEO

of Durect.

" If approved, we expect these products to generate significant value

for our shareholders since Durect will receive royalties based on net

sales of Remoxy and other licensed ORADUR products of between 6.0% to

11.5% (depending on sales volume) and a manufacturing mark-up on key

product excipients, in addition to payments upon achievement of

development milestones and reimbursement of our development costs. "

Dr. Brown continued, " We are also delighted with the continued

advancement of our ORADUR technology platform, and are excited about

its potential as a platform for numerous other innovative products

given its unique combination of sustained-release and abuse-resistant

properties. We look forward to developing additional innovative

sustained release oral gel-cap products that utilize opioids not

subject to our alliance with Pain Therapeutics and King and other

active agents prone to abuse. "

Special Protocol Assessment

A Special Protocol Assessment (SPA) from the FDA specifies the Phase

III trial objective, design, clinical endpoints and analyses needed

to support regulatory approval. These features are considered

binding, i.e., the FDA will not later alter its perspective unless

public health concerns unrecognized at the time of protocol

assessment under this process are evident. For more information

please visit the FDA website:

http://www.fda.gov/CbER/gdlns/protocol.pdf.

Phase III Trial Details (as announced by Pain Therapeutics and King

Pharmaceuticals)

Under the terms of the SPA for Remoxy, one pivotal Phase III trial is

required to file a New Drug Application. The randomized, double-

blinded, placebo-controlled, multi-center pivotal trial will enroll

400 patients with moderate-to-severe osteoarthritic pain in multiple

U.S. clinical sites. Following a titration period, patients will be

randomized to either Remoxy (10-80 mg daily) or placebo for 12 weeks.

The primary endpoint is reduction in pain scores over three months

compared to baseline. Patient accrual is expected to begin shortly

and continue through year end 2006.

About ORADUR

ORADUR sustained released oral gel-cap technology provides the unique

characteristics of Remoxy and the referenced follow-on products.

Products based on the ORADUR technology can take the form of an easy

to swallow gelatin capsule that uses a high-viscosity base component,

SABER, to provide sustained release of active ingredients for a

period of from 12 to 24 hours of drug delivery. Oral dosage forms

based on the ORADUR gel-cap may also have the added benefit of being

less prone to abuse than other controlled release dosage forms on the

market today. ORADUR-based products can be manufactured by a simple

process using conventional methods making them readily scalable.

These properties have the potential to make ORADUR-based products an

attractive option for pharmaceutical companies that seek to develop

tamper and abuse resistant oral products.

About Remoxy

Remoxy is an oral, long-acting oxycodone capsule under development by

Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. that

incorporates several abuse-deterrent properties and offers the

convenience of twice-a-day dosing. Remoxy is formulated with Durect

Corporation's ORADUR technology under a development and license

agreement between Durect and Pain Therapeutics. Under the terms of

the license agreement between Pain Therapeutics and Durect, Pain

Therapeutics has exclusive worldwide rights to develop and to

commercialize Remoxy and other ORADUR-based products using three

other opioid drugs. Durect is reimbursed for formulation and other

work performed under its agreement with Pain Therapeutics, and will

receive milestone payments based on the achievement of certain

technical, clinical or regulatory milestones, in addition to

receiving royalties on end product sales. Pain Therapeutics has

sublicensed the commercialization rights of Remoxy to King

Pharmaceuticals. Oxycodone is the active drug ingredient in Remoxy

and in the branded product OxyContin®. OxyContin®, the leading

brand name opioid used in the treatment of moderate-to-severe pain,

has U.S. sales of nearly $2 billion for the 12-months ending August

2005, according to IMS Health data. Drug abusers can easily extract

oxycodone from OxyContin® tablets in order to induce a quick and

powerful euphoric high. Oxycodone abusers risk respiratory

depression, which can be fatal, and opioid addiction.

About Durect Corporation

Durect Corporation is an emerging specialty pharmaceutical company

focused on the development of pharmaceutical systems based on its

proprietary drug delivery platform technologies. The company is

developing pharmaceutical systems to deliver the right drug to the

right place in the right amount at the right time to treat chronic

and episodic diseases and conditions.