Promising new migraine drug could reach market by spring

Dr. Mark Lenaerts explains the science behind a promising new migraine under review by the FDA.

All these years I’ve been cursing migraine, wondering why my brain wants to torture me, and I’ve never known what was really to blame.

Turns out, the neurotransmitter CGRP is the enemy. This is not a new discovery. Researchers in the early 1980's first discovered that the protein molecule CGRP (calcitonin gene-related peptide) was present in high concentrations in people experiencing migraine attacks and at higher-than-normal concentrations all the time in people who suffer from chronic migraine, said Dr. Marc Lenaerts, a neurologist and professor with UC Davis Health System.

CGRP causes the inflammation in the membrane around the brain that results in the pain of migraine.

Attempts were made to develop a therapy targeting CGRP, but the FDA gave the resulting medication thumbs down because it was toxic to the liver. And with that, research hit a wall, Lenaerts said.

For decades the discovery lay fallow, until recent advances in manufacturing antibodies to go after specific molecules made it feasible to revisit development of a therapy involving the problematic protein.

For about the past two years, ever since a friend posted a Scientific American story about a new migraine drug in the pipeline on my Facebook wall, I’ve been following progress on it. As someone who has gone to great lenghths and expense in fighting migraine with only very limited success, this is a development of great interest.

Last week the news broke that the FDA accepted the application of pharmaceutical giants Amgen and Novartis for its drug, Aimovig, a CGRP inhibitor. The drug could hit the market by next spring, and Dr. Lenaerts, a popular Sacramento headache specialist, is optimistic about its potential for migraine sufferers.

Due to the advances in manufacturing antibodies, researchers have been able to develop a molecule that reduces CGRP levels without the liver toxicity of the earlier drug, he said.

Other pharmaceutical houses besides Amgen and Novartis are hot on the trail of a CGRP blocking therapy, including Teva and Eli Lilly.

In trials for Aimovig, “most people improve to some degree, and a few improve tremendously,” Lenaerts said.

For someone like me who has been battling intense, debilitating and increasingly frequent migraines for about 14 years, those words are like music to my ears.

Besides writing about the progress of this new therapy, which I’m sure most migraineurs (and those who love them) will read with interest, I dearly hope to shed a little light on what it means to live with migraine. I don’t like to complain about it (okay that’s a lie. I love to complain, I’ve just been socialized to keep it to a minimum) but like anyone, I wish to be understood.

As with many afflictions, it can be hard to understand unless you’ve experienced it. Just as I don’t know what it means to lose a child or battle cancer, others don’t know what it’s like to spend a certain number of days out of nearly every month curled in a ball in bed in horrible pain, only getting up to vomit.

Sacramento native Joan Didion possibly summed up living with migraine best in her 1968 essay, ‘In Bed.’

“That no one dies of migraine seems, to someone deep into an attack, an ambiguous blessing,” she wrote.

She came to terms with hers, regarding it “as more friend than lodger.” She found value in migraine’s ‘imposed yoga’ that forced her to focus on the pain to the exclusion of all else.

“…when the pain recedes, ten or twelve hours later, everything goes with it, all the hidden resentments, all the vain anxieties. The migraine has acted as a circuit breaker, and the fuses have emerged intact. There is a pleasant convalescent euphoria. I open the windows and feel the air, eat gratefully, sleep well. I notice the particular nature of a flower in a glass on the stair landing. I count my blessings.”

While I agree that there is nothing so wonderful as when the pain finally ebbs, and I can leave my darkened room and walk outside into the air and light and return to the world of the living – so far I have not reached sufficient enlightenment to see migraine as anything but a horrible curse I resent having to bear.

But getting back to the Aimovig. New drugs make me nervous. Despite FDA approval, no one really knows what long term, down the road effects could be. Lenaerts noted that occasionally, as in the case of Vioxx, a pain medication prescribed for osteoarthritis that was recalled due to increased risk of heart attack and stroke, the FDA gets it wrong.

But I’m at the point where I’m desperate enough to be the guinea pig. Someone has to be. 

© 2017 KXTV-TV


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