Pfizer Relpax is seventh triptan
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Pfizer's migraine therapy Relpax (eletriptan) clears FDA Dec. 26, becoming the seventh approved triptan. Approval was delayed while Pfizer conducted FDA-requested cardiovascular safety trials addressing safety of higher doses. FDA approved 20 mg and 40 mg single doses, but not 80 mg. The larger dose had higher response rates in five of six efficacy studies, but with more adverse events. Labeling allows for a maximum of two daily doses not to exceed 80 mg. Pfizer will launch Relpax during the first quarte