Featured Research

from universities, journals, and other organizations

Novel, Orally Inhaled Migraine Therapy Is Effective, Study Shows

Date:
August 14, 2009
Source:
Thomas Jefferson University
Summary:
A new study shows an investigational, orally-inhaled therapy is effective in treating migraines. The multi-center, phase three FREEDOM-301 trial for the orally-inhaled migraine therapy, LEVADEX, shows study participants had significant relief from symptoms such as pain, nausea and light and sound sensitivity when compared to placebo treatment.

A new study conducted at the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania shows an investigational, orally-inhaled therapy is effective in treating migraines. The multi-center, phase three FREEDOM-301 trial for the orally-inhaled migraine therapy, LEVADEX™, shows study participants had significant relief from symptoms such as pain, nausea and light and sound sensitivity when compared to placebo treatment.

According to trial results, this therapy provided pain relief in 30 minutes and sustained relief for 48 hours after dosing in patients with moderate or severe migraine attacks. The drug was generally very well tolerated and there were no drug-related, serious adverse events reported.

According to the American Headache Society (AHS), migraine is a common, debilitating neurological disorder that affects approximately 30 million people in the United States. The AHS also states that most migraines last between four and 24 hours, but some may last as long as three days. Common associated symptoms of migraine include nausea, vomiting, photophobia (sensitivity to light) and phonophobia (sensitivity to sound).

"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," said Stephen Silberstein, M.D., F.A.C.P, a clinical study investigator, director of the Jefferson Headache Center, and professor in the Department of Neurology at Jefferson Medical College of Thomas Jefferson University.

About the FREEDOM-301 Study

FREEDOM-301 is a multi-center, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the safety and efficacy of LEVADEX as a potential treatment for acute migraine. Primary efficacy measures include pain relief, and being free from phonophobia, photophobia and nausea at two hours after dosing. Patients enrolled in the trial were evaluated for the treatment of a single moderate or severe migraine attack and then were given the option to continue in an open label, long-term safety study. This safety study is targeting 300 patients for six months and 150 patients for 12 months, and over 500 patients are continuing in this arm of the trial. FREEDOM-301, the first Phase 3 study of LEVADEX therapy, was conducted pursuant to a Special Protocol Assessment with the U.S. Food and Drug Administration. The FREEDOM-301 trial is sponsored by MAP Pharmaceuticals, Inc.

About LEVADEX™

LEVADEX orally inhaled migraine therapy is a novel migraine therapy in Phase 3 development. Patients administer LEVADEX themselves using MAP Pharmaceuticals' proprietary TEMPO® inhaler. LEVADEX has been designed to be differentiated from existing migraine treatments. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings for many years to effectively and safely treat migraines. Based on clinical results, MAP Pharmaceuticals believes that 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.

Based on research to date, including the FREEDOM-301 trial, MAP Pharmaceuticals believes the unique pharmacokinetic profile of LEVADEX has the potential to effectively treat migraines, while minimizing the side effects commonly seen with DHE and other currently available medicines.

About the Jefferson Headache Center

The Jefferson Headache Center is one of a very few academic headache centers in the country. The Center, founded in 1982, specializes in the treatment of patients with all types of headache pain. In addition to treating patients, the Jefferson Headache Center is a teaching facility that gives trainees the highest quality of preparation so that they can make contributions to patient care and advance the level of knowledge of headache medicine. The Fellowship program prepares Fellows for a career in clinical headache practice or academic headache medicine and/or research. The Jefferson Headache Center is also deeply involved in research. The Clinical Research team is made up of the Clinical Research Manager, several Research Coordinators, and a Clinical Trials Assistant. For more information, visit http://www.jefferson.edu/headache.

Editor's Note: LEVADEX and TEMPO are trademarks of MAP Pharmaceuticals, Inc. Dr. Silberstein serves on the Advisory Board for MAP Pharmaceuticals.


Story Source:

The above story is based on materials provided by Thomas Jefferson University. Note: Materials may be edited for content and length.


Cite This Page:

Thomas Jefferson University. "Novel, Orally Inhaled Migraine Therapy Is Effective, Study Shows." ScienceDaily. ScienceDaily, 14 August 2009. <www.sciencedaily.com/releases/2009/08/090811143546.htm>.
Thomas Jefferson University. (2009, August 14). Novel, Orally Inhaled Migraine Therapy Is Effective, Study Shows. ScienceDaily. Retrieved October 21, 2014 from www.sciencedaily.com/releases/2009/08/090811143546.htm
Thomas Jefferson University. "Novel, Orally Inhaled Migraine Therapy Is Effective, Study Shows." ScienceDaily. www.sciencedaily.com/releases/2009/08/090811143546.htm (accessed October 21, 2014).

Share This



More Mind & Brain News

Tuesday, October 21, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

First-Of-Its-Kind Treatment Gives Man Ability To Walk Again

Newsy (Oct. 21, 2014) — A medical team has for the first time given a man the ability to walk again after transplanting cells from his brain onto his severed spinal cord. Video provided by Newsy
Powered by NewsLook.com
Your Birth Season Might Determine Your Temperament

Your Birth Season Might Determine Your Temperament

Newsy (Oct. 20, 2014) — A new study says the season you're born in can determine your temperament — and one season has a surprising outcome. Video provided by Newsy
Powered by NewsLook.com
Movies Might Desensitize Violence For Parents, Not Just Kids

Movies Might Desensitize Violence For Parents, Not Just Kids

Newsy (Oct. 20, 2014) — A study suggests that parents become desensitized to violent movies as well as children, which leads them to allow their kids to view violent films. Video provided by Newsy
Powered by NewsLook.com
Court Ruling Means Kids' Online Activity Could Be On Parents

Court Ruling Means Kids' Online Activity Could Be On Parents

Newsy (Oct. 17, 2014) — In a ruling attorneys for both sides agreed was a first of its kind, a Georgia appeals court said parents can be held liable for what kids put online. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins