Capnia, Inc., a diversified healthcare company, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to the company’s 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.
“Receiving orphan designation from the FDA is a key step in the advancement of our nasal CO2 technology, and speaks to the need for new treatment options for the debilitating pain caused by TN, where limited alternatives currently exist,” said Anish Bhatnagar, M.D., chief executive officer of Capnia.
“We continue to execute on our strategy of bringing novel therapies based on our nasal CO2 technology to patients as quickly as possible.”
Capnia's therapeutic technology uses nasal, non-inhaled carbon dioxide, delivered at a low-flow rate into the nasal cavity to target local trigeminal nerve endings. Multiple clinical trials for the treatment of allergies as well as pain conditions (such as migraine) have been completed using this technology. The use of nasal CO2 for the treatment of TN is supported by 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 US, 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. The designation provides Capnia's nasal CO2 therapeutic with certain benefits, including seven years of US market exclusivity in the specified indication if Capnia complies with certain FDA requirements. Additional incentives for Capnia include tax credits related to qualified clinical trial expenses and a exemption from FDA application fees.