Desitin Files For European Regulatory Approval For Sumavel DosePro

Zogenix and Desitin Pharmaceuticals (Desitin) have reported that Desitin has filed for European regulatory approval of Sumavel DosePro (sumatriptan injection) needle-free delivery system.

Reportedly, the announcement follows successful completion of a European pivotal bioequivalence trial, comparing needle-free Sumavel DosePro to a traditional needle-based autoinjector, Imigran-Inject, the European brand of Imitrex STATdose System.

Sumavel DosePro was recently approved by the FDA to treat acute migraine, with or without aura, and cluster headache, and will be launched by Zogenix in the US in January 2010.

Sumavel DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients. In clinical trials, the drug was shown to be absorbed rapidly, resulting in peak plasma concentrations within approximately 12 minutes. Overall safety profiles were comparable for Sumavel DosePro and Imitrex STATdose System.

Martin Zentgraf, general manager at Desitin, said: “This filing demonstrates Desitin’s ability to move this product candidate through development and into the European regulatory approval process. Subject to regulatory approval, we look forward to launching it with our CNS-focused sales representatives and partner companies in the major European countries, bringing this important product candidate to the market for the benefit of patients.”

Roger Hawley, director and CEO of Zogenix, said: “Sumavel DosePro is a unique new product which we believe has broad global appeal. With FDA approval and commercial manufacturing in place, Desitin’s achievement of this milestone in Europe with Sumavel DosePro will attract the attention of other companies who may be interested in our technology for delivery of their drugs in other therapeutic areas, including biologics.”