New migraine treatment to be available in US this month
May 4th, 2010 by Jennifer Walker-Journey
A medication approved by the Food and Drug Administration (FDA) to treat migraine headaches is scheduled to become available in the United States this month. Cambia (diclofenac potassium for oral solution) was found to reduce migraine pain within 30 minutes, according to a study published in Cephalalgia, the international journal of headache.
Data from the International Migraine Pain Assessment Clinical Trial (IMPACT) showed clinically significant improvement following treatment with Cambia in all four FDA-mandated co-primary endpoints for migraine – pain, nausea, potophobia and ponophobia.
“Our study demonstrates that diclofenac potassium for oral solution relieved the pain and reduced the other key migraine symptoms, quickly, effectively and safely,” said lead investigator Richard B. Lipton, M.D., professor and vice chairman of Neurology and professor of Epidemiology and Population Health at Albert Einstein College of Medicine in New York. “This unique formulation provides high rates of absorption, most likely accounting for the rapid onset of action,” added Lipton, who also directs the Montefiore Headache Center.
Cambia, made by Nautilus Neurosciences, is the only prescription non-steroidal anti-inflammatory drug (NSAID) available for the acute treatment of migraine with or without aura. It carries the same health risks as other NSAIDS, including a rare but life-threatening hypersensitivity disorder known as Stevens Johnson Syndrome (SJS) and is most serious form, toxic epidermal necrolysis (TEN). SJS and TEN can be fatal. Patients who experience a rash while using Cambia should discontinue the medication immediately.