Phase III clinical trials for Levadex, a new Migraine abortive medication are progressing well. Levadex, from MAP Pharmaceuticals, has been referred to as MAP004 previously.
In a Phase III clinical trial at the Jefferson Headache Center in Philadelphia, participants who received Levadex experienced greater relief from pain, nausea, sensitivity sound, and sensitivity to light than participants who received the placebo.
During the trial, for patients with moderate to severe Migraines, pain relief was achieved within 30 minutes, with sustained relief for 48 hours.
Dr. Stephen Silberstein, director of the Jefferson Headache Center stated,
"The major advantage of Levadex is that it has the efficacy of intravenous DHE (dihydroergotamine) with a side-effect profile similar to placebo and better than oral triptans."
At first glance, Levadex may not seem like anything new, but research to this point indicates that it may very well be a "new and improved" version of an old friend, DHE (dihydroergotamine). Currently available forms of DHE are DHE-45 subcutaneous injections, Migranal Nasal Spray, and DHE IV infusions used in clinics and hospitals.
Levadex delivers DHE in a method different than any other Migraine medication, via a hand-held, unique oral inhaler called Tempo. Temp looks somewhat like an asthma inhaler, but works differently. Rather than the patient having to time pumping the inhaler at the right time with their breathing, Tempo is breath synchronized. It is inserted in the mouth, then automatically synchronizes itself with the patient's breathing and dispenses the medication at the right moment.
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Resources:
HealthDay News. "New Migraine Drug Shows Promise." HealthScout. August 14, 2009.
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© Teri Robert, 2009Last updated August 24, 2009
