Aradigm said that the Danish Medicines Agency of Denmark has approved Zogenix and Desitin Pharmaceuticals' marketing authorisation application (MAA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system.
Zogenix and Desitin Pharma claim that Sumavel DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan.
Sumavel DosePro may offer a treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injections and helps in acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.
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 European Union decentralised procedure.
Aradigm president and CEO Igor Gonda said they are very pleased that this exciting product is now entering the commercialisation stage in Europe.
"It is also very gratifying that Zogenix, which has further developed Sumavel DosePro using the technology and product originally in development at Aradigm, launched the product in the US last January and the product is being used by migraine sufferers," Gonda said.