Promising New Migraine Medication Up For FDA Approval

There are 8.5 million people in Britain who suffer from migraines and nearly five times as many in the United States. Obviously this is a major concern for the medical community as migraines are not just a nuisance but can be quite debilitating for those who experience them. 

Fortunately, for the roughly 50 million people worldwide who suffer from migraine, a new medication might provide much-needed relief. 

A new drug from pharmaceutical giant Allergan is currently awaiting approval from the United States Food and Drug Administration, with licenses pending in Europe and Asia as well.  This drug is known as ubrogepant, and it has been tested by a team at the Montefiore Headache Center, in New York. 

In the trial, 1,700 patients were given a placebo or one of two doses of the drug:  some were given a 25 mg dose and others were given a 50 mg dose. Twenty percent of the patients in the low-dose cohort reported pain alleviation within two hours.  Also, more than 34 percent said they felt relief from the most troublesome symptoms. 

These symptoms include not only headache but also nausea, vomiting, and extreme sensory sensitivity to light, smell, and noise.

As might be expected, the higher dose cohort reported better results, but only slightly.  About 21.8 percent of patients reported pain alleviation within the same two hour period.  Only 38.9 percent reported improvement of the other symptoms. 

By comparison, though, the placebo group only reported 14 and 27 percent improvement of symptoms, respectively. w

Study leader Dr. Richard B. Lipton is the director of the Montefiore Headache Center.  He explains, “Having ubrogepant as a potential new medication for the acute treatment of migraine will provide much-needed innovation for a disease that causes lost time for millions of people.”

At the same time, the researchers note that the drug is still not as effective at relieving migraine symptoms as triptans, which is the current standard treatment for severe migraine.  Triptans constricts the blood vessels around the brain to stop the pain and shows response rates in the 40 to 75 percent range. But this also means patients with heart disease and stroke cannot take this treatment for migraines, hence the need for a new drug.  Triptans also have side effects—dizziness, drowsiness, and numbness—which can be quite unpleasant.