Zogenix and Desitin Pharmaceuticals have received the Federal Institute for Drugs and Medical Devices of Germany (BrArM), and the Medicines and Healthcare products Regulatory Agency of the UK (MHRA) approval for the Marketing Authorization Application (MAA) for Sumavel DosePro needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.
Sumavel DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan as a potential treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection.
Sumavel DosePro (sumatriptan injection) is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.
Desitin general manager Martin Zentgraf said that with MAA approvals in Denmark, and now Germany and the UK, preparations are underway for the European Union product launch in early 2011 through their CNS-focused sales representatives and partner companies.
"We are currently awaiting additional EU marketing authorizations under our strategy to commercialize Sumavel DosePro throughout the territory," Zentgraf said.
Zogenix CEO and director Roger Hawley said that Sumavel DosePro has been granted marketing authorization in Germany and the UK, two of the largest pharmaceutical markets in Europe, five weeks after receiving its initial European Union approval in Denmark.