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news.Durect has announced that the FDA has granted the company orphan drug designation for bupivacaine for relief of persistent pain associated with post-herpetic neuralgia.
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Bupivacaine is the active pharmaceutical ingredient in Eladur, the company’s investigational transdermal drug patch. If Eladur becomes the first bupivacaine product approved for post-herpetic neuralgia (PHN), under the 1983 Orphan Drug Act, Eladur will receive seven years of market exclusivity following the approval of the product by the FDA, the company said.
Eladur is an investigational transdermal drug patch intended to deliver bupivacaine for up to three days from a single application, as compared to a wearing time limited to 12 hours with currently available anesthetic patches.
James Brown, president and CEO of Durect, said: “The receipt of orphan drug status enhances the product opportunity for Eladur, including providing a more favorable development pathway. We are continuing to develop Eladur as a potentially best in class transdermal product for those suffering from PHN.”