FDA Grants Orphan Drug Designation to Cognetix' Investigational CGX-1160 for the Treatment of Chronic Intractable Pain.SALT LAKE CITY -- Cognetix Inc., a biotechnology company focused on the development of drugs for chronic intractable pain, today announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted an Orphan Drug designation to Cognetix lead compound CGX-1160 for the intrathecal intrathecal /in·tra·the·cal/ (-the´k'l) within a sheath; through the theca of the spinal cord into the subarachnoid space. Intrathecal treatment of neuropathic pain associated with spinal cord injury Spinal Cord Injury Definition Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control. Description Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States. . CGX CGX Consolidated Graphics Inc. CGX Meigs Field, Chicago, Illinois (Airport Code) 1160 has completed a Phase 1b clinical trial for the treatment of chronic, intractable pain at Brigham and Womens Hospital in Boston. About FDA Orphan Drug Designation Products designated as orphan drugs are those that are being developed to treat diseases affecting fewer than 200,000 people in the United States. 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' Clinical Development Program Cognetix lead compound, CGX-1160 is based on a novel peptide synthesized from marine cone snails. Safety margins observed in the Phase 1b clinical trial at Brigham and Womens are consistent with the Company's extensive pre-clinical data demonstrating that CGX-1160 is a broad spectrum non-opioid analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs with a wide safety margin. As such, CGX-1160 could provide physicians and patients with the "next generation" of conopeptide-based analgesics that have been designed to address safety considerations, such as narrow therapeutic index, inherent in first-generation conopeptides for pain management. About Cognetix Cognetix has demonstrated that conopeptides represent a large and diverse pharmacopoeia pharmacopoeia or pharmocopeia (fär'məkəpē`ə), authoritative publication designating the properties, action, use, dosage, and standards of strength and purity of drugs. of bioactive molecules with subtype selective activity at many molecular targets of interest in CNS See Continuous net settlement. CNS See continuous net settlement (CNS). pharmaceutical drug development. Cognetix synthesizes peptides from cone snails and leverages these potent compounds to create a variety of therapeutics including non-narcotic pain medications and other CNS therapeutics. The Company's drug discovery program is powered by a platform consisting of the world's most extensive conopeptide data base. The Company's patent portfolio on conopeptide sequences, uses, synthesis and methods consists of 80 issued or allowed U.S. and international patents and an additional 80 patents pending. |
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