Inhaled migraine drug Levadex effective in hard-to-treat headaches: MAP

Levadex, an inhaled, fast-acting formulation of dihydroergotamine, from MAP Pharmaceuticals has been found effective in hard-to-treat migraine headaches.

Levadex is found to be effective in treating acute migraine as well as a broad spectrum of migraine, including migraine subpopulations that are often resistant to current therapies such as triptans

Levadex can also address migraine with moderate and severe pain, migraine with nausea and vomiting and migraine with and without aura, suggests data from phase 3 clinical studies which MAP is planning to present at the 14th Congress of the International Headache Society.

“Based on these Phase 3 data, Levadex has the potential to provide rapid and sustained pain relief, along with a favorable tolerability profile,” stated Stewart Tepper, MD, Director of Research for the Center for Headache and Pain, Cleveland Clinic, in a press release.

Levadex is a new orally inhaled formulation of dihydroergotamine (DHE). DHE is a known drug currently being used intravenously in clinical settings to treat migraines. Levadex has the potential to provide both fast onset of action and sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy, says MAP.

Levadex is designed to incorporate the multiple beneficial mechanisms of action. Through this, Levadex  allows DHE to block initiation of migraine, limit pain, reduce inflammation and stop a migraine at any point in the migraine cycle.

Levadex’ unique pharmacokinetic profile helps minimize the side effects commonly seen with DHE while effectively treating migraine.

There were no drug-related serious adverse events reported in the trial. Levadex was well tolerated, with the most common adverse event reported being medication aftertaste at six percent.

The next most common adverse event was nausea at five percent, compared with two percent for placebo. Symptoms or sensitivities typically associated with commonly used triptan migraine treatments, such as chest discomfort (one percent) or chest pain (0 percent), were rare and comparable to placebo. There were no decreases in lung function, as measured by spirometry, between the active and placebo groups.

Limitations of oral triptans, the class of prescription drugs widely used for migraines, include slow onset of significant pain relief between 45 and 90 minutes, substantial variability in patient response and side effects such as heightened blood pressure.

MAP said it plans to launch another Phase 3 trial of Levadex in the first quarter of next year.

What is Migraine?
Migraine is a common, debilitating neurological disorder that affects approximately 30 million people in the United States, according to the National Headache Foundation. Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound). According to the National Headache Foundation, most migraines last between four and 24 hours, but some last as long as three days.

On average, migraine sufferers experience 1.5 migraine attacks monthly, although 25 percent of them experience one or more attacks weekly, according to published studies. Migraine patients often report that currently approved drugs do not fully meet their needs due to slow onset of action, short duration of effect, inconsistent response and unacceptable side effect profiles. The economic burden of migraine remains substantial despite existing treatments, with the direct and indirect costs of migraine in the United States estimated at over $20 billion annually.

MAP Pharmaceuticals specializes in applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk by capitalizing on their known safety, efficacy and commercialization history.