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|Sumavel™ DosePro™ (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache|
First Product Featuring Novel DosePro Needle-Free Delivery System
SAN DIEGO, Calif., (July 16, 2009): Zogenix, Inc. (“Zogenix”), a privately held pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system 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.
“In my 28 years treating migraine patients, a consistent challenge has been delivering fast relief in a patient acceptable form,” said Roger K. Cady, M.D., director of the Headache Care Center in Springfield, Mo. “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.”
Triptans, the most commonly prescribed class of drugs for the treatment of migraine, are a $3.3 billion market in the U.S (Source: Wolters Kluwer Health, Source® Pharmaceutical Audit Suite (PHAST). Based on AWP for U.S. retail prescriptions of drugs in the triptan market, May 2008 —April 2009.) According to the National Headache Foundation, acute migraines affect nearly 30 million Americans. Tablets are a treatment option for some migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed particularly for those who experience migraine episodes associated with sudden onset, waking, nausea or vomiting.
The FDA approval of Sumavel DosePro is based on extensive efficacy and safety data from original filings for needle-based sumatriptan injection (IMITREX®), in addition to clinical studies conducted by Zogenix on bioequivalence, usability and safety specific to the Sumavel DosePro combination drug/needle-free delivery system.
“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 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 migraine or cluster headache should be reconsidered before administration of a second dose.
Important Safety Information
Sumavel DosePro should not be used within 24 hours of other ergotamine-containing or ergot-type medications or other 5-HT1 agonists and is not generally recommended for use with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors SNRIs or MAO inhibitors. Sumavel DosePro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most common adverse events observed in controlled clinical trials with sumatriptan injection were injection site reactions, atypical sensations (such as feelings of tingling, warm/hot sensations), dizziness and flushing. Most side effects lasted for only a short time. In clinical trials comparing the safety and tolerability of Sumavel DosePro to sumatriptan injection, most injection site reactions resolved spontaneously, with no apparent difference between Sumavel DosePro and sumatriptan needle injection.
For full prescribing information, click here.
About DosePro technology
Zogenix™, Sumavel™ and DosePro™ are trademarks of Zogenix, Inc.