Durect (DRRX)

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Durect receives FDA Oprhan Drug Designation

ELADUR(TM) Development Update: DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia
49 minutes ago - Pr Newswire

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As of 9:49 AM ET 6/30/08
DURECT Corporation (Nasdaq: DRRX) announced today that the US Food and Drug Administration (FDA) has granted to DURECT orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia (PHN). Bupivacaine is the active pharmaceutical ingredient in ELADUR(TM), DURECT's investigational transdermal drug patch. If ELADUR is the first bupivacaine product approved for PHN, under the 1983 Orphan Drug Act ELADUR will receive seven years of market exclusivity following the approval of the product by the FDA.

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"The receipt of orphan drug status enhances the product opportunity for ELADUR, including providing a more favorable development pathway," stated James E. Brown, DVM, President and CEO of DURECT. "We are continuing to develop ELADUR as a potentially best in class transdermal product for those suffering from PHN."

ELADUR is an investigational transdermal drug patch intended to deliver bupivacaine for up to 3 days from a single application, as compared to a wearing time limited to 12 hours with currently available anesthetic patches (e.g., Lidoderm(R), an FDA-approved lidocaine patch for post-herpetic neuralgia pain management). Bupivacaine, the active agent in ELADUR, is a potent, FDA-approved long-acting local anesthetic used in regional anesthesia for local tissue infiltration, nerve block, and epidural and intrathecal anesthesia. DURECT currently retains full commercial rights to this product candidate.

DURECT has previously announced positive results for ELADUR from a 60 patient Phase IIa clinical trial of patients suffering from post-herpetic neuralgia. In this study, ELADUR showed improved pain control versus placebo during the 3-day continuous treatment period. In addition, ELADUR appeared to be well tolerated overall, and patients treated with ELADUR and placebo exhibited similar safety profiles. A poster describing this study was presented at the 27th Annual Scientific Meeting of the American Pain Society on May 8, 2008 and is accessible on our website (http://www.durect.com/wt/durect/page_name/Publications).