SOLENO THERAPEUTICS, INC. Capnia, Inc. announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Orphan Drug Designation for its nasal, non-inhaled carbon dioxide (nasal CO2) technology for the treatment of trigeminal neuralgia (TN). TN is a clinical condition characterized by debilitating pain in regions of the face innervated by one or more divisions of the trigeminal nerve. The pain is typically described as intense, sharp and stabbing, and is often described as one of the most painful conditions known to humans.
It may develop without apparent cause or be a result of another diagnosed disorder, including multiple sclerosis and herpes zoster. The company's therapeutic technology uses nasal, non-inhaled CO2, delivered at a low-flow rate into the nasal cavity to alleviate symptoms of allergies as well as pain disorders related to the trigeminal nerve. The company developed Serenz for the treatment of allergy symptoms, and has completed multiple clinical trials for the treatment of pain (such as migraine) using this technology.
The use of company's nasal CO2 product for the treatment of TN is supported by preclinical and clinical data demonstrating that CO2 may inhibit sensory nerve activation, subsequent release of neuropeptides and alleviate trigeminally mediated pain. Collectively, these data suggest that nasal CO2 may provide relief of symptoms associated with TN. In the U.S., under the Orphan Drug Act, the FDA's Office of Orphan Products Development grants orphan drug status to a drug intended to treat a rare disease or condition, which is generally a disease that affects fewer than 200,000 individuals in the country.
Upon approval, the designation would provide the company's nasal CO2 therapeutic with certain benefits, including seven years of U.S. market exclusivity in the specified indication if the company complies with certain FDA requirements. Additional incentives for the company would include tax credits related to qualified clinical trial expenses and a possible exemption from FDA application fees.
