Zogenix and Desitin Pharmaceuticals' Sumavel DosePro (sumatriptan injection) Needle-Free Delivery System marketing authorization application (MAA) has received Danish Medicines Agency of Denmark approval.
Zogenix and Desitin said Sumavel DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan and is designed for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.
Sumavel DosePro may offer a treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection.
Zogenix CEO and director Roger Hawley said the MAA approval of Sumavel DosePro in Denmark creates a point of entry into the EU market and they look forward to the upcoming EU commercial launch by their partner Desitin.
Desitin plans to launch Sumavel DosePro in Denmark in early 2011 and is responsible for pursuing additional MAA approvals and broader commercialisation on a country-by-country basis under the EU decentralized procedure.
Reportedly, in March 2008, Zogenix and Desitin have entered into a license agreement granting exclusive rights in the European Union to Desitin to develop and commercialise Sumavel DosePro.