The drug industry might finally have an answer for migraines

often it begins with aura.

zigzagging lines come to light, the light becomes every day searingly bright, and vision begins to slip. These are signs that a debilitating migraine is coming.

“It’s as if possessed,” said Lorie Novak, who has suffered from chronic migraines since childhood. “I almost feel separated from my body, as if it were just this painful shell around me that’s not me.”

The article continues after the announcement

Novak, now about 60 years, is one of the approximately 35 million Americans who suffer from migraines. There are few effective treatments, and no new drugs have been developed since the early 1990s

But that could soon change. A handful of drug companies are pushing new injectable therapies for migraines, chasing a market highly successful Wall Street analysts say could reach $ 8 billion a year in sales worldwide.

New drugs target a protein called CGRP body, which plays a role in the dilation of blood vessels in the brain. Scientists have not stuck to what extent the protein affects migraines, but they are sure of two things :. CGRP levels rockets when they attack headaches and normalize when they go

And therefore four drugmakers – Amgen, Eli Lilly, Teva Pharmaceuticals, and Alder Biopharmaceuticals – have formed antibodies that can bind to molecules of CGRP and block its activity. The goal: to alleviate the scourge of chronic migraines, stopping in their tracks CGRP

.

So far, it seems to be working. In the middle stage clinical trials, each of the four treatments has alleviated symptoms about half of study participants, reducing the number of days that are affected by migraine roughly half. It is by no means a cure for migraines, but it should be enough to merit the approval of the Food and Drug Administration whether companies can replicate these results in larger trials, according to Eric Schmidt, securities analyst at Cowen and Co. .

Each treatment is now in final stages of development, targeting about 38 percent of migraine sufferers who, like Novak, have at least four days per month with headache. The first therapy could reach the market in 2018, and, if all goes well, the four could be available by the end of the decade.

So far, the four drugs have performed similarly in clinical trials, and analysts expect that the contestants have to compete on price to gain market share.

“No doubt there will be hyper,” said William Ratner, senior director of global marketing for Lilly headache. But the fate of companies are intertwined, he said, and “class only win if care in America headache improvement.”

In order to prevent migraines before they start

There is much room for improvement. Existing therapies are affected by inconsistent efficacy and troublesome side effects, and patients are often left to rely on a treatment for epilepsy reused. That drug, Topamax, has been nicknamed nicknamed “Sleepomax” by doctors and patients because it is also a heavy sedative.

“I’m very enthusiastic, because I believe that everyone in the field is to have another treatment option for people with migraines,” said Dr. Elizabeth Loder, a professor of neurology at the Medical School and Harvard chief of the division of headache in the department of neurology at the hospital Brigham and Women.

CGRP orientation is not a new idea in particular. Researchers collected in the smell of the protein more than 30 years ago, and pharmaceutical companies spent years trying to develop pills that could block its activity. Merck obtained the way into late-stage trials with anti-CGRP pill, spending more than $ 1 billion in 2011 only to find that the drug has toxic effects on the liver and therefore no future.

The “exquisite sensitivity” of an antibody, however, scientists believe they can block CGRP without causing dangerous side effects, said CEO Randy Schatzman Alder.

Because antibodies remain active in the body for weeks, pharmaceutical companies see their new products as preventive therapies, injected monthly or quarterly to hold off headaches. (Merck failed tablet, however, is understood as a field treatment after the pain began.)

“Therefore, in a sense, is a paradigm shift,” Schatzman said.

However, there are still obstacles to clear. Only half of patients appear to respond to CGRP antibodies, and companies have no way to predict who they are early. A genetic test would be “the Holy Grail of personalized medicine,” said Rob Lenz, head of global development at Amgen for neuroscience, but no one has done so far.

and long-term safety remains a big question mark. To date, none of the companies reported serious side effects in clinical trials, but have only presented data from studies of 12 weeks at about 1,500 patients in total. It will take years to determine exactly what new therapies make the body over time, Loder said.

“I felt my life was being stolen from me ‘

Any advance, even an incremental, would be a big step for the field, said Emily Bates, who studies the genetic causes of headaches at the University of Colorado and is not affiliated with any of the companies working in treatment migraine.

Bates had problems with chronic migraines in high school and college. Like many patients who do not respond to any of the preventive therapies available.

“Pain is more than anything I’ve ever experienced, and I have found in the legs broken before,” he said. “I felt my life was being stolen from me.”

Overall, Americans lose about 113 million working days per year because of migraine. That lost productivity costs society about $ 13 billion each year, according to the Research Foundation of migraine.

However, scientific progress has been slow, in part because migraine was long considered a psychosomatic condition is not worthy of serious research funding, Bates said.

is a “subjective symptom that affects predominantly women,” Loder, the Harvard neurologist said. “That is a perfect combination of things that make people feel able to dismiss it.”

Novak, professor of photography at the Tisch School of the Arts at New York University, spent years trying to hide their migraines because of the stigma associated with the disease. But she decided to change all that in 2009 with a project called migraine Register . She takes a picture of herself every day has a migraine. Some years, that’s more than 120 images.

The idea, in part, was to humanize chronic migraines. But the project also forced Novak to take into account the number of victims of the disease, something she had tried to ignore for years.

“That to me was as a concrete proof of how it really affects my life,” Novak said, “the amount of time I miss.”

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