Nautilus Neurosciences, Inc., a neurology-focused specialty pharmaceutical company headquartered in New Jersey, announced that Cambia (diclofenac potassium for oral solution) is now available in the United States for the acute treatment of migraine with or without aura. Cambia was approved by the US Food and Drug Administration in June 2009.
“The approval and subsequent commercialization of Cambia as a unique formulation of diclofenac offers an important treatment option for the millions of people who suffer from migraines,” said Alan M. Rapoport, M.D., clinical professor of neurology at the David Geffen School of Medicine at UCLA and founder and director-emeritus of the New England Center for Headache in Stamford, Connecticut. “With a simple, quick administration that can be used at any time during a migraine attack, Cambia offers rapid onset of pain relief with an established safety profile.”
Migraine affects more than 36 million people in the United States, 75 per cent of them women. According to a survey published in the Journal of the American Board of Family Medicine, many migraineurs still hope to find a better treatment for their migraines, with more than a quarter dissatisfied with their treatment and fewer than a fifth of migraineurs describing themselves as “very satisfied” with their treatment.
A novel, water-soluble, buffered diclofenac potassium powder, Cambia is the only prescription Non-steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine. Engineered using Dynamic Buffering Technology (DBT), a patented absorption-enhancing technology developed by APR Applied Pharma Research S.A., Cambia is specifically designed for fast, effective relief from the symptoms of migraine. Cambia enters the bloodstream quickly and readily achieves peak plasma concentrations, providing rapid onset of pain relief via oral therapy without increasing the patient’s total exposure to diclofenac.
“The US availability of Cambia represents an important milestone for Nautilus and an important new product for the millions of Americans who suffer from migraines,” said James Fares, chairman and CEO, Nautilus Neurosciences. “The launch of Cambia further establishes our corporate commitment to bringing unique products to those in need and being a true partner with the migraine community. The unique formulation of Cambia provides a new treatment option that can reduce key migraine symptoms quickly, effectively and safely.”
The FDA approval of Cambia was based on two Phase 3 placebo-controlled trials showing that Cambia was superior to placebo in all four FDA-mandated co-primary end points for migraine — pain, nausea, photophobia and phonophobia. Both studies also showed that reduction in pain intensity was significantly greater in the Cambia up than in the placebo group as early as 15 minutes following treatment, and headache response rates were superior to placebo for up to 24 hours.
With the combined results of the two clinical trials, the safety of a single dose of Cambia was evaluated in a total of 634 migraineurs treated with Cambia for a single migraine attack. No subjects withdrew due to adverse events, and the overall incidence of adverse events was comparable to placebo. There were no serious adverse events or deaths. The most common adverse events reported following treatment with Cambia (>1 per cent incidence) were gastrointestinal disorders (12 per cent), general disorders and administration site conditions (1.5 per cent), nervous system disorders (4.1 per cent) and psychiatric disorders (2.6 per cent).
Nautilus Neurosciences is a neurology-focused specialty pharmaceutical company committed to providing the health care community with relevant products and services that directly benefit those affected by neurologic disorders.