The Food and Drug Administration (FDA) has approved Cambia™, a diclofenac-based nonsteroidal anti-inflammatory drug (NSAID) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults. Cambia is not indicated for the prophylactic therapy of migraine, and the safety and effectiveness of Cambia have not been established for cluster headache, typically present in an older and predominantly male population.

Cambia is formulated using a patented buffering technology designed to offer fast and effective relief of migraine pain. In randomized clinical trials, Cambia was shown to be effective not only in migraine pain, but also in treating photophobia, phonophobia, and nausea commonly associated with migraine attacks. Cambia provided statistically significant onset of relief of migraine pain within 15 to 30 minutes. Cambia is administered as a 50-mg packet designed to be mixed with 1 to 2 ounces of water.

Cambia labeling includes warnings that NSAIDS may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, and that risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk since NSAIDs increase the risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal event. Cambia is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft.

Migraine headaches affect an estimated 30 million individuals in the United States and disproportionately affect women 3 to 1. According to a recent peer-reviewed publication authored by leading migraine researchers, more than 70% of patients indicated that they were less than completely satisfied with their current treatment. Over 85% complained that pain relief took too long and 25% decided to stop seeking treatment altogether. Cambia is manufactured by Kowa Pharmaceuticals America Inc.

1. Food and Drug Administration (FDA) [website]. Highlights of Prescribing Information. Updated May 2009. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022165lbl.pdf. Accessed June 29, 2009.

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This entry was posted on Monday, June 29th, 2009 at 12:00 pm.