Orally inhaled migraine drug dihydroergotamine (Levadex) is safer, fast-acting, says Map Pharma

Levadex, a novel orally inhaled formulation of dihydroergotamine (DHE) to treat migraine headaches by Map Pharmaceuticals, Inc has been found highly safe and effective in late phase human studies.

Map announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of inhaled dihydroergotamine Levadex met all four primary endpoints.

Map was anticipating a second pivotal efficacy study for inhaled dihydroergotamine Levadex in the first quarter of 2010.

However, the U.S. Food and Drug Administration (FDA) has informed Map that a second pivotal efficacy study is not required for its inhaled dihydroergotamine Levadex new drug application (NDA) submission for the acute treatment of migraine.

“We believe that Levadex has the potential to provide rapid and sustained relief of migraine symptoms to many of the approximately 30 million migraine sufferers in the U.S., including many who are not helped by currently available migraine therapies and we are committed to rapidly moving this program forward, ” stated Timothy S. Nelson, president and chief executive officer of Map Pharmaceuticals.

The remaining clinical studies include the ongoing 12 month open-label safety extension of the FREEDOM-301 study, a pharmacokinetic (PK) study and a pharmacodynamic (PD) study. The Company anticipates that patients in these studies will complete treatment in 2010.

The goal of the long-term safety extension is to evaluate overall safety, including pulmonary and cardiovascular safety, of Levadex in 300 patients for six months and 150 patients, including asthmatics, for 12 months. The study is being conducted under a Special Protocol Assessment with the FDA.

As of October 2009, more than 400 patients had completed at least six months of treatment in the inhaled dihydroergotamine Levadex trials and over 7,800 headaches had been treated, with no drug-related serious adverse events reported.

The PK study will compare the safety, PK and metabolic profiles of Levadex with IV dihydroergotamine (DHE) in smokers. The PD study will evaluate pulmonary artery pressure in healthy volunteers.

Patients administer Levadex themselves using the company’s proprietary Tempo inhaler.

Data from this Phase 3 trial show the potential for Levadex to be effective in treating acute migraine as well as a broad spectrum of migraine subpopulations that are often difficult to treat with current therapies, including triptans.

For example in this trial, patients with allodynia, menstrual migraine, migraine with nausea and vomiting, severe migraine and those treating late in their migraine cycle responded well to Levadex.

Levadex is designed to be differentiated from existing migraine treatments.

Levadex is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines.

Levadex has the potential to provide both fast onset of action, sustained pain relief and other migraine symptom relief in an easy-to-use and non-invasive at-home therapy, Map said in a press release.

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

What is migraine?

Common symptoms of migraine include recurrent headaches, nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).

Most migraines last between four and 24 hours, but some last as long as three days, according to the National Headache Foundation.

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 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 direct and indirect costs of migraine in the United States estimated at over $20 billion annually.

Map Pharmaceuticals generates new pipeline opportunities by 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.