New treatment launched for migraines in U.S.

A neurology-focused specialty pharmaceutical company has launched diclofenac potassium for oral solution (Cambia, Nautilus Neurosciences Inc.) for the acute treatment of migraine with or without aura in the United States. FDA approved the prescription medication in June 2009.

The solution is the only migraine medication available in the United States that comes in a powder for oral solution, James Fares, chairman and CEO of Bridgewater, N.J.-based Nautilus Neurosciences, told Formulary.

More than 36 million Americans suffer from migraines -75% of whom are women. According to a survey published in the Journal of the American Board of Family Medicine, many migraine sufferers still hope to find a better treatment for their migraines, with more than one-quarter dissatisfied with their treatment, and fewer than one-fifth describe themselves as “very satisfied” with their treatment.

A water-soluble, buffered diclofenac potassium powder 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.

“Cambia offers unparalleled speed of onset for the tens of millions of migraine sufferers in the United States,” Fares said.

FDA approved the drug based on 2 phase 3 placebo-controlled trials showing that it was superior to placebo in all 4 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 diclofenac group 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 2 clinical trials, the safety of a single dose of diclofenac was evaluated in 634 migraineurs treated with the medication for a single migraine attack. No subjects withdrew because of 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 diclofenac (>1% incidence) were gastrointestinal disorders (12%), general disorders and administration site conditions (1.5%), nervous system disorders (4.1%), and psychiatric disorders (2.6%).

The technology behind the medication (Dynamic Buffering Technology) is exclusive to this drug and patent protected into the next decade, Fares said. Diclofenac is also the only prescription nonsteroidal anti-inflammatory drug to receive FDA approval for the acute treatment of migraine in adults.