FDA Approves NDA For Zogenix’ Sumavel DosePro

Zogenix has got approval from the US FDA for its New Drug Application (NDA) on Sumavel DosePro (sumatriptan injection) needle-free delivery system. It is to treat acute migraine, with or without aura, and cluster headache.

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, said the company.

Roger Cady, director of the Headache Care Center in Springfield, said: In my 28 years treating migraine patients, a consistent challenge has been delivering fast relief in a patient acceptable form. Sumavel DosePro will be a welcome treatment option because it combines key benefits – the rapid efficacy of subcutaneous sumatriptan and a simple to use needle-free delivery system.

The FDA approval of Sumavel DosePro is based on efficacy and safety data from original filings for needle-based sumatriptan injection (IMITREX). This is in addition to clinical studies conducted by Zogenix on bioequivalence, usability and safety specific to the Sumavel DosePro combination drug/needle-free delivery system.

Stephen Farr, president, chief operating officer, and director of Zogenix, said: We are pleased to receive approval from the FDA for Sumavel DosePro, our first commercial product. We believe our DosePro technology represents a ground-breaking advancement in the self-administration of subcutaneous medications without a needle.

Zogenix plans to launch Sumavel DosePro with its own sales force and a co-promotion partner, and will make the product commercially available soon.