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news.The FDA has granted 'orphan drug' designation to Cognetix's lead compound CGX-1160 for the intrathecal treatment of neuropathic pain associated with spinal cord injury.
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Products designated as orphan drugs are those that are being developed to treat diseases affecting fewer than 200,000 people in the US. 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.
Cognetix lead compound, CGX-1160 is based on a novel peptide synthesized from marine cone snails. Safety margins observed in the phase Ib clinical trial at Brigham and Womens Hospital in Boston are consistent with the company’s extensive preclinical data demonstrating that CGX-1160 is a broad spectrum non-opioid analgesic with a wide safety margin.