Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Deliv...(ety specific to the Sumavel DosePro comb...)

"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," said Stephen Farr, Ph.D., president, chief operating officer and director of Zogenix. "We fully expect this FDA approval to catalyze DosePro licensing discussions in several other therapeutic areas."

"During market research sessions with health care providers and migraine patients, 'cool' was one of the most common responses to Sumavel DosePro - that's a very unusual description in this industry," said Roger Hawley, chief executive officer and director of Zogenix. "We believe our novel DosePro delivery system could transform the future of subcutaneous drug delivery of pharmaceuticals. This first approval was made possible by years of dedication and shared entrepreneurial spirit of our Zogenix team, our business partners and our investors."

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

About Sumavel DosePro

Sumavel DosePro (sumatriptan injection) needle-free delivery system is indicated for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache episodes.

Sumavel DosePro should only be used where a clear diagnosis of migraine or cluster headache has been established. Sumavel DosePro is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine and should not be administered intravenously. For a given attack, if a patient does not respond to the first dose of Sumavel DosePro, the diagnosis of mi
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