May 28, 2009 — An orally inhaled formulation of dihydroergotamine (Levadex, formerly referred to as MAP0004, MAP Pharmaceuticals), an intravenous migraine therapy, is moving closer to becoming the first available inhaled therapy for migraine relief following release of encouraging phase 3 data.
The new data showed that patients taking Levadex had significantly more pain relief, reduced sensitivity to light and sound, and less nausea compared with those receiving placebo.
The research showed that the drug demonstrated a unique rapid onset of action — within a half hour — and that the response is sustained for several hours, said Sheena Aurora, MD, director of the Swedish Headache Center at the University of Washington School of Medicine, in Seattle, who was a clinical study investigator for the study.
"What was astounding was that we were able to show 48 hours of sustained pain relief," said Dr. Aurora. "No other migraine therapy has shown 48 hours of sustained pain relief compared with placebo," she told Medscape Psychiatry.
Current prescription migraine therapies, including oral triptan drugs, "are not very effective in terms of having a quick response and a sustained response," she said.
Potential as First-Line Therapy?
The randomized, double-blind study included 792 patients aged 18 to 65 years who were evaluated for the treatment of a single moderate or severe migraine.
The study showed that Levadex therapy achieved statistically significant onset of pain relief at 30 minutes and that the therapy achieved statistically significant sustained pain relief from 2 to 24 hours as well as 2 to 48 hours.
In the Levadex group, 58.7% experienced pain relief compared with 34.5% of patients taking placebo.
Also in the active-agent group, 52.9% became phonophobia (sound-sensitivity) free, and 46.6% photophobia (light-sensitivity) free compared with 33.8% and 27.2%, respectively, for patients in the control group.
As for nausea, 67.1% of the patients in the Levadex group did not experience this symptom compared with 58.7% in the placebo group.
The drug was generally well tolerated, with no reports of serious adverse events.
The drug is designed to target various neurotransmitters, blocking initiation of migraine, limiting pain, and reducing inflammation. "If it worked so well in the moderate to severe attacks, we think it can probably work at basically any phase of a migraine," said Dr. Aurora.
As with any vasoconstrictor, Levadex should not be taken by patients who have coronary artery disease, are at risk for stroke, or have blood vessel problems, said Dr. Aurora.
This drug has the potential to become a first-line therapy because, unlike its intravenous counterpart, it is practical and easy to use and does not require a trip to the doctor or clinic, said Dr. Aurora. "The inhaled preparation gives you the same benefit of the [intravenous] drug, but you can take it at home."
She said she does not know when the drug will be marketed.
The study was conducted under a special protocol assessment agreement with the US Food and Drug Administration.
According to background information provided by the company, migraine sufferers experience an average of 1.5 migraine attacks monthly, although 25 percent of sufferers experience 1 or more attacks weekly. The direct and indirect costs of migraine in the United States are an estimated $20 billion annually.
Dr. Aurora Is a study Investigator with Freedom-301.
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Cite this: New Inhaled Migraine Therapy Shows Promise In Phase 3 Trial - Medscape - May 28, 2009.