FDA GRANTS ORPHAN-DRUG DESIGNATION TO CGX-1160

Cognetix announced that the FDA has granted an orphan-drug designation to its lead compound, CGX-1160, for the intrathecal treatment of neuropathic pain associated with spinal cord injury. CGX 1160 has completed a Phase Ib clinical trial for the treatment of chronic, intractable pain at Brigham and Women's Hospital in Boston.

Products designated as orphan drugs are those that are being developed to treat diseases affecting fewer than 200,000 people in the U.S. The Orphan Drug Act guarantees seven years of market exclusivity to the first sponsor that obtains market approval for an orphan-designated product. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a waiver from the FDA user fee for review of an application for the indication designated.