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Tuesday, February 9th, 2010

Press Release: Medication for postherpetic neuralgia pain

Internet-News_NC

DURECT Receives Orphan Drug Designation for Bupivacaine for Post-Herpetic Neuralgia

CUPERTINO, Calif., June 30 /PRNewswire-FirstCall/ — Durect Corporation 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.

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).

SOURCE: Durect Corporation

Image: Newscom

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