Sumatriptan Oral Spray is NovaDel’s proprietary oral spray formulation of sumatriptan being developed for the potential treatment of migraine headaches. Sumatriptan is the active ingredient in GlaxoSmithKline’s Imitrex®, the leading prescription therapy for migraines in the U.S., which is available as a tablet and in injectable and intranasal formulations.  

NovaDel announced positive data from a pilot pharmacokinetic study on Sumatriptan Oral Spray in September 2006.  The study was a four-arm, crossover pharmacokinetic study comparing 50 mg Imitrex tablets to 20 mg and 30 mg of the oral spray in 10 healthy male volunteers under fasting conditions.  The pharmacokinetic parameters of the 20 mg oral spray after a meal were also evaluated.  The study demonstrated a statistically significantly faster rate of absorption than Imitrex tablets and up to a 50% increase in relative bioavailability of drug.  Importantly, the rate of drug absorption is believed to be predictive of the degree and speed of migraine relief.  Although Imitrex nasal spray was not included in this clinical study, time to the first peak plasma concentration of sumatriptan was approximately 70% faster with the 20 mg oral spray than what has been reported in the literature for the same dose of the Imitrex nasal spray.  In addition, the mean concentration level achieved during this critical first phase of absorption was approximately 30% greater for the oral spray than what was observed in published studies of the nasal spray.

Current Status
NovaDel plans to continue its clinical development efforts for sumatriptan oral spray and to build its portfolio toward a New Drug Application (NDA) for this compound with the FDA in 2008.

If successfully developed, a lingual spray formulation of sumatriptan could prove to be of great utility to migraine sufferers, as nausea and vomiting are common symptoms, potential faster absorption could translate into faster onset of action, and the delivery method could have distinct convenience advantages over other formulations, particularly the injectable version of the therapy.

The Migraine Market
According to the American Medical Association, an estimated 26 million people in the U.S. suffer from migraines.  An estimated 150 million workdays, which translates into 1,200 million work hours, are reported lost due to the onset of migraines.  Migraines cost employers an estimated $13 billion annually.  Sales of Imitrex are estimated to be approximately $1.0 billion, representing roughly half of the migraine market.  The U.S. patent exclusivity for Imitrex expires in February 2009.

Imitrex®, Zofran® and Requip® are registered trademarks of GlaxoSmithKline. Ambien® is a registered trademark of Sanofi-Aventis. Zanaflex® is a registered trademark of Acordia Therapeutics Inc. ZolpiMist™ and NitroMist™ are trademarks of NovaDel Pharma, Inc. Zensana™ is a pending trademark of Hana Biosciences.