Millions of acute migraine sufferers around the world now have a new treatment option, which one Kansas City doctor says “may be the next great thing.”
“Migraine is the third-most prevalent disease in the world – foremost among common neurological illnesses,” says Dr. John C. Hagan III, editor of Missouri Medicine, a peer-reviewed journal in publication since 1904. “One out of every four households in the United States has someone with migraine; there are over 42 million Americans and more than a billion migraine headache sufferers world-wide.”
Hagan says he and Dr. Steven C. Kosa helped develop and study a new beta blocker nasal spray, which has shown great promise in the treatment of acute migraine symptoms. In fact, their groundbreaking new study shows 62.5% of patients who used the spray showed improvement.
“This is the first reported case series of a nasally delivered beta blocker (timolol 0.5%) for treatment of acute migraine,” the study claims.
“In a retrospective chart review, 16 patients were found who had received intranasal timolol for sub-optimally treated acute migraines. Of these, 10 (62.5%) reported to their provider that the medication was helpful. Encouragingly, the treatment was beneficial even for patients previously [resistant] to other medications.”
Further, the study showed only one patient experienced any side effects, in this case mild nasal congestion, indicating the medication was generally well tolerated.
Based on these findings, Hagan and Kosa suggest more robust research is needed, which would hopefully lead to FDA approval, increased production of the spray and even lower cost.
He’s worked tirelessly for over 10 years to get to this point. Were it not for his perseverance and a little luck, it’s likely millions of acute migraine sufferers would still be left with treatments that many say simply don’t work.
Beta blockers, invented in the 1960s, were originally used to treat cardiovascular disease, and are among the safest, most widely used medications in the world. Oral beta blocker medications have been FDA approved for this treatment, and for the treatment of migraines for decades.
However, while the oral beta blockers have been effective in treating chronic migraines (more than 15 per month), this has not been the case for acute, severe-with-sudden-onset symptoms, leaving millions with little or no effective treatment options.
That all began to change about 10 years ago when a conversation between two friends on the golf course kicked off a decade-long journey to find an answer for acute migraine sufferers.
In 2013, while playing golf with him, Hagan mentioned to his friend Dr. Carl V. Migliazzo, a glaucoma specialist, that his two daughters had developed acute migraines and weren’t finding any effective treatments. When Migliazzo suggested he try beta blockers for his daughters, Hagan was quick to remind him they weren’t effective for acute migraines. But Migliazzo convinced Hagan to try it when he described what he’d observed while using beta blocker eye drops to treat glaucoma patients.
Much like the cardiovascular patients who found the oral beta blockers helped treat their chronic migraines, Migliazzo said many of his glaucoma patients began to report the beta blocker eye drops also helped with their acute migraine symptoms.
The question then was, what made beta blocker eye drops effective for acute migraines when oral beta blockers had failed?
The answer, said Hagan and Migliazzo in a 2014 research paper, is the pills take far too long to be absorbed in the blood at a “therapeutic level” to effectively reduce or alleviate acute symptoms.
The drops, however, were found to absorb at a much faster rate.
This, the doctors say, is because the drops quickly run out of the eye through the tear ducts, where they are then absorbed through the nose almost as quickly as if administered by IV.
“We report seven cases of successful treatment of acute migraine symptoms using beta blocker eye drops,” the paper states. “Oral beta blocker medication is not effective for acute migraine treatment.
“This is likely due to a relatively slow rate of achieving therapeutic plasma levels when taken orally. Topical beta blocker eye drops achieve therapeutic plasma levels within minutes … which may explain their apparent effectiveness in treating acute migraine symptoms.”
Since the eye drops were so quickly absorbed through the nose, the doctors theorized that a beta blocker nasal spray would be even more effective.
But this, Hagan says, is the most frustrating part.
Hagan had hoped the news was big enough to spur others in the field of neurology or big pharma to take up the mantle of expanding on his and his colleagues’ research. Grants and larger scale studies are necessary to verify these results and hopefully push toward FDA approval. Much to his chagrin, after 10 years of trying to convince Big Pharma companies to develop the spray into an FDA-approved product, he found them remarkably uninterested.
The most common reasons for their disinterest, he says, were they didn’t think the product would make enough money, or it would compete with more-expensive options they already have on the market.
Frustrated but not deterred, Hagan approached a mid-size pharma company headquartered in Kansas City with which he had worked in the past, O’Brien Compounding Pharmacy.
Thankfully for the millions of acute migraine sufferers around the world, Hagan and Kosa were able to convince O’Brien to produce the nasal spray 0.5% timolol compound to treat acute migraine symptoms for patients with a valid prescription, which can be purchased online here.
As of January, the price of a 15 ml bottle, which is enough to treat multiple migraines, was roughly $77, while a 30 ml bottle was $112, making it an affordable option as well.
Still, Hagan holds out hope Big Pharma will have a change of heart.
“It should not be this difficult to get acute migraine sufferers all over the world a new-use, inexpensive, safe-when-properly-used and very effective treatment for one of the world’s most common diseases.”