Nautilus Neurosciences announced results from its International Migraine Pain Assessment Clinical Trial (IMPACT) with Cambia (buffered diclofenac potassium powder for oral solution) for acute migraine treatment. The IMPACT study showed clinically significant improvements following treatment with Cambia in all four FDA-mandated co-primary endpoints for migraine — pain, nausea, photophobia and phonophobia. IMPACT was a multicenter, double-blind, double-dummy, randomized, placebo-controlled, single-attack trial comparing Cambia and placebo in 807 participants 18 to 65 years of age. All four co-primary endpoints were significantly different from the placebo treatment group in favor of Cambia.
Cambia was approved by the FDA in June 2009. It is expected to be available to the U.S. market sometime in May 2010.
For more information call (908) 393-7800 or visit www.nautilusneurosciences.com.