Do migraines make your life miserable? If so, you're not alone.
The National Headache Foundation (yes, there is such an organization) says that around 30 million Americans suffer from migraines. Researchers found that $11 billion is spent annually on medical expenses related to migraines.
There's hope for some good news, though. Several companies are hard at work developing drugs that could make your migraines milder. Here are three with development under way for new migraine treatments.
1. Allergan (NYSE: AGN )
Allergan is best known as the maker of Botox. While the drug gained prominence for smoothing out wrinkles, another benefit was found along the way. The U.S. Food and Drug Administration approved use of Botox as a treatment for migraines in 2010, but the drug can be prescribed only for patients with the most acute severe headaches.
Botox isn't Allergan's only effort in helping migraine sufferers, though. The company acquired Levadex when it bought Map Pharmaceuticals earlier this year. However, the FDA gave a thumbs-down to Levadex in April due to manufacturing issues. Allergan expects to submit data needed by the FDA by the end of this year and hopes to obtain approval for the drug in the second quarter of 2014.
Levadex is an orally inhaled formulation of dihydroergotamine, or DHE. While DHE is already available as a nasal spray and in intravenous form, Allergan thinks that Levadex will act faster, last longer, and have fewer side effects than many currently available products.
2. Eli Lilly (NYSE: LLY )
Large drugmaker Eli Lilly licensed its experimental migraine drug LY2951742 to tiny partner Arteaus Therapeutics in 2011. The two companies are working together to develop the drug, which is now in a mid-stage clinical trial.
Lilly and Arteaus don't only want to decrease the pain from migraines with LY2951742. They hope to also prevent migraines from occurring. LY2951742 is an antibody that neutralizes a brain protein known as calcitonin gene-related peptide, or CGRP. CGRP dilates blood vessels and causes inflammation in the brain, which can lead to migraine headaches.
The latest information available estimates the the mid-stage clinical study for LY2951742 will wrap up in October. Assuming all goes well, the drug would then progress into a phase 3 study. If that study is also successful, the earliest time frame for availability to patients would likely be 2015.
3. Merck (NYSE: MRK )
Although Merck canceled a late-stage study for a migraine drug in 2011 and another one a couple of years earlier, the company still has another treatment in its pipeline. Merck's MK-1602 is in phase 2 development.
MK-1602, like Lilly's LY2951742, focuses on the CGRP protein. However, Merck's drug is an oral CGRP receptor antagonist rather than an antibody. CGRP antagonists work by blocking the receptors of the protein. This group of drugs doesn't appear to work quite as well as other migraine drugs already on the market, including Merck's own Maxalt, but the CGRP antagonists don't seem to have some of the serious side effects of these earlier drugs.
Not much information has been forthcoming as of yet on the MK-1602 testing. A phase 2b study wrapped up in late 2012, but the results have not been released.
And then some
Others are also at work on migraine treatments. Venture-capitalist-backed Alder Biopharmaceuticals has clinical studies under way for its CGRP-targeting antibody ALD403. Bristol-Myers Squibb (NYSE: BMY ) counts a CGRP antagonist, BMS-927711, in its pipeline. However, Bloomberg reported earlier this year that Bristol might sell the drug. No official announcement has been made by Bristol about the matter, though.
Even though millions of Americans suffer from migraines, don't look for any of the larger companies mentioned to experience huge gains from successes with their development programs for migraine treatments. Financial services firm Cowen and Company estimates that the migraine drug market will actually decline from $1.6 billion in 2012 to only around $630 million in 2017, largely because of new generic entrants.
Investors might not be happy, but migraine sufferers could gain at least a little relief. If one or more of the newer drugs in development prove to be successful, better treatments could be on the way in the future. And even if not, patients will at least get a little financial relief with more lower-cost generic drugs on the market.
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