October 12, 2016
By Alex Keown, BioSpace.com Breaking News Staff
DUBLIN, Ireland – Your head feels like it’s trapped in an ever tightening vice. You feel nauseous and the lone lightbulb in the room seems as bright and intense as the noon-day sun. It’s an excruciating migraine.
Migraines impact about 12 percent of the population in the United States, including children. The pain and other symptoms associated with migraines can cause sufferers to completely stop what they are doing and prevent them from working or functioning in a normal capacity for more than a day. Of migraine sufferers, about 4 million suffer from chronic daily migraines, meaning they are dealing with 15 migraines each month.
Ireland-based Allergan is one company leading the way in developing treatments for migraines. The company’s blockbuster Botox has a long history of being used as an approved treatment for chronic migraine headaches. In fact, some patients who receive Botox as a treatment for migraines are often in a state of near-permanent migraines, C. David Nicholson, Allergan’s brand head of research and development, told BioSpace in an exclusive interview.
“Botox treatment has changed the lives of patients with migraines and Allergan is into migraines due to Botox,” Nicholson said in a telephone interview.
Now, based on the success of Botox in treating chronic migraine pain, Allergan is deepening its commitment to migraine therapies. Nicholson said Allergan has been looking to build out its “migraine franchise” and had the opportunity to acquire a proven treatment—a small oral molecule calcitonin gene-related peptide (CGRP) receptor antagonist program from Merck . Last year Allergan struck a $250 million deal with Merck for the oral treatment as a front-line treatment for the prevention of migraine headaches.
“CGRPs have been proven to work in migraines… it’s a totally validated target,” Nicholson said. This is a migraine frontline therapy. We need more therapies. It’s just under treated… Having multiple therapies on the market will be good for the patient and will expand the total market.”
CGRP is an inflammatory and pain alleviator, Nicholson said, but how it actually works in preventing migraines is still up for debate.
“There’s been a raging debate whether it works in the brain, or peripherally, modulating pain fibers projecting to the brain. The present belief is they don’t need to get into the brain to be effective. This is still an incompletely understood area of science,” Nicholson said.
Allergan currently has two CGRP compounds in clinical trials. A Phase III trial is examining the compound for the acute treatment of migraine, to prevent the migraine attack, Nicholson said. Another compound is in a Phase II trial for migraine prophylaxis, for patients who experience frequent attacks and need a daily treatment. The fact that both of these therapies are small molecule oral treatments are likely to make them a preferable treatment over injectables and intravenous treatments. Botox is administered as an injection by a neurologist once every few months for migraine treatment. Nichols said the company did not have a timeline for when it may submit the CGRP small molecule to regulatory agencies. He said the company was focused on completing the development and to “reproduce the efficacy and safety.”
“We believe there is a need for it. We are happy to be the leading company with oral CGRP antagonists,” Nicholson said. “This will be the best case for patients who can continue to live their life without having to (always) go to the doctor.”
Nicholson said the oral CGRP treatments will complement the use of Botox for chronic migraine pain, particularly since the CGRP treatments are being developed as front-line treatments and Botox is used when many other treatments have proven ineffective.
Although cost has not yet been determined, Nicholson said the use of CGRP small molecules will likely be less expensive than CGRP antagonists.
In addition to the CGRP therapy, Allergan has also developed an inhaled treatment, which the company hopes to submit for regulatory approval within the next year, Nicholson said. If approved, it could compete with Avanir Pharmaceuticals ’ Onzetra migraine medication, a nasal inhalant approved by the FDA in January. Onzetra (sumatriptan nasal powder) is a fast-acting dry powder formulation of sumatriptan, one of the most commonly prescribed migraine medication.
