May 2, 2017
By Alex Keown, BioSpace.com Breaking News Staff
Despite the success of Botox as an effective treatment for chronic migraine cases, Allergan is focused on developing additional treatments, including preventatives, for the crippling pain associated with the fierce headaches.
In an exclusive interview with BioSpace, David Nicholson, Allergan’s head of R&D, said the company remains committed to developing treatments for migraine headaches, which impact about 12 percent of the U.S. population. About four million of those suffer from chronic migraines, meaning they are dealing with 15 migraines each month.
“When I talk with physicians and neurologists working in headache clinics, Botox administration changes peoples’ lives,” Nicholson said.
When used in treating migraines, Botox has been shown to produce a 50 percent reduction in migraine days in 50 percent of patients, he said, calling that statistic a “really, significant benefit for individuals who haven’t received relief from other sources of therapy.”
While Botox is often regarded as a treatment for cosmetic practices, Nicholson said a larger proportion of Botox sales comes from therapeutic uses, with migraine treatment being among the largest.
Not only is the company continuing to focus on pain treatments with its blockbuster neurotoxin Botox, it is also developing chronic migraine therapies using calcitonin gene-related peptides (CGRP) antagonists. Nicholson said Allergan continues to move forward with Phase II and Phase III clinical trials for two experimental CGRPs, which alleviate pain and inflammation. It’s thought the CGRP drugs can cross the blood-brain barrier and will be an effective treatment for migraines. A Phase III trial is examining ubrogepant, a CGRP antagonist, for the acute treatment of migraine. As a preventative, Allergan has a Phase II trial of another CGRP antagonist, atogepant. Nicholson said recruitment for the trials is happening at a pace more rapid than the company expected, “which shows enthusiasm among medical professionals for CGRP treatment.”
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.
If the trials go as planned, Nicholson said Allergan should have the first data results from the ubrogepant study in the first half of next year. If the drugs pass through their hurdles, they are expected to be the first CGRP receptor antagonists to market for migraine treatment.
Work is also continuing on Allergan’s inhaled migraine treatment, Semprana, Nicholson said. Allergan has completed the clinical work for Semprana, but Nicholson said they are sorting out some manufacturing issues. Although he did not describe the problems, Nicholson said the hope is they will be resolved later this year and the company will then be able to provide more information on possible regulatory approval.
At the end of April, Allergan made multiple presentations at the American Academy of Neurology meeting in Boston, several of which focused on chronic migraine disease and related therapies.
Not only is the company interested in developing therapeutics for migraines, Lisa Kim, associate director of Allergan, said the company is also committed to understanding what patients go through when dealing with the pain. The company has unveiled the “Frame of Mind” campaign, inviting migraine sufferers to submit artwork that reflects what they’re going through when they have migraines. The artwork will be displayed at the American Headache Society later this year.
“We want to have a display. We want to have people who are affected by migraines project what they’re going through,” Kim said.
In addition to migraine treatment, Nicholson said Allergan also remains focused on developing therapies for Alzheimer’s symptoms. Rather than attempt to develop a drug that will be a preventative for Alzheimer’s, Nicholson said the company has become a leader in treating the symptoms of Alzheimer’s. Allergan has two approved drugs for Alzheimer’s, Namenda and Namzaric, which treat problems like memory loss. The drugs though do not stave off the advancement of the disease.
“I would love it if somebody was able to come up with a therapy to prevent the progression of Alzheimer’s. So far, unfortunately, everything is failing in slowing the progression. We’re left with the small number of symptomatic treatments, of which Allergan is a leader,” Nicholson said.
In addition to its two approved treatments, Allergan has a cholinesterase inhibitor that will be in Phase II development later this year.
Despite all of the failures of potential Alzheimer’s treatments, such as Eli Lilly ’s anti-amyloid drug solanezumab, Nicholson said it’s the potential of finding an effective treatment is something that keeps researchers plugging away at the elusive brass ring.
“It’s why we work in the pharmaceutical industry. It’s why we get up in the morning,” he said.
