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Patent Awarded for Migraine Drug Inhalation Method

Migraine (Sasha Wolff/Flickr)MAP Pharmaceuticals Inc. in Mountain View, California says it received a U.S. patent for its formulation and method of administering the drug dihydroergotamine (DHE) used to treat migraine headaches. Patent 8,119,639 from the U.S. Patent and Trademark Office was awarded to four inventors including Thomas Armer, MAP Pharmaceuticals’s chief scientific officer.

DHE is a type of medication called ergot alkaloids that treats migraines by tightening blood vessels in the brain and stopping the release of natural substances in the brain that cause swelling. The drug is currently administered to treat migraines in progress either by injection or nasal spray.

The patent covers MAP Pharmaceuticals’s formulation of DHE designed for use in an inhaler, also developed by the company. The formulation, says the company, is devised to bind to receptors causing the migraine conditions within two hours, but be delivered in precise concentrations below the levels that can cause side effects.

The drug, called Levadex by the company, is currently under review by the FDA. A phase 3 clinical trial of the drug showed greater pain and nausea relief, as well as less sensitivity to sound and light, compared to a placebo. The trial also showed no serious drug-related adverse events, with the most common side-effect complaints being a drug after-taste and nausea.

MAP Pharmaceuticals says its inhaler is hand-held, designed to deliver precise metered doses of DHE, and automatically synchronizes with the breathing patterns of the user. It includes a dose counter, but uses no batteries or external power sources.

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Photo: Sasha Wolff/Flickr

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