AbbVie’s migraine drug Qulipta wins FDA nod as a preventive migraine treatment

Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches.

In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both of those products are indicated for the acute treatment of migraines with or without aura.

North Chicago–based AbbVie published results from the pivotal ADVANCE study in The New England Journal of Medicine.

Qulipta bottle image courtesy of AbbVie

Participants in the trial had a mean number of monthly migraine days ranging from 7.5 to 7.9. Recipients of 10-mg atogepant saw an average reduction of 3.7 days in migraine days per month. For the sake of comparison, recipients of 30-mg atogepant …

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Why Impel NeuroPharma is targeting the migraine market

(PRNewsfoto/Impel NeuroPharma)

The analgesic dihydroergotamine (DHE) has perhaps the longest track record of any effective migraine medicine.

Seattle-based Impel NeuroPharma (NSDQ:IMPL) aims to reestablish DHE as a cornerstone of acute migraine treatment following the FDA approval of Trudhesa, a DHE nasal spray. Trudhesa uses the company’s Precision Olfactory Delivery (POD) that delivers the drug to the vasculature within the upper nasal cavity.

“I’ve been in this field for 30 years. I still have the privilege of seeing patients, and nothing in the realm of new treatments has quite met that need that DHE fulfills,” said Dr. Sheena K. Aurora, vice president of medical affairs, migraine at Impel NeuroPharma. DHE continues to offer compelling efficacy for, say, patients who wake up in the morning with a migraine and patients with menstrually-associated migraine.

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Satsuma launches Phase 3 trial for acute migraine drug 

Satsuma Pharmaceuticals (NSDQ:STSA) has announced that it has enrolled the first patient in its SUMMIT Phase 3 efficacy trial of STS101, a drug-device product that is a potential acute treatment of migraine.

STS101 is a nasal powder containing dihydroergotamine (DHE), an analgesic already available to treat migraines and cluster headaches. In fact, migraine patients have used DHE as an acute migraine treatment since 1946. But approved DHE products are “inconvenient or have an inconsistent response,” according to a paper published in Neurology. “Newer development-stage products may provide enhanced [pharmacokinetics], improved clinical efficacy, and more patient-friendly administration,” the article continued.

South San Francisco, Calif.–based Satsuma believes that STS101 could thus lead to higher efficacy over traditional dihydroergotamine-based nasal sprays.

“We believe the likelihood of success for SUMMIT is high given the utilization of the second-gen…

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Meet the drugs and devices giving hope to millions of migraine patients

Photo by Liza Summer from Pexels

Migraines are an ancient condition. In about 400 B.C., Hippocrates described visual symptoms of migraine aura that precede headache onset.

But up until recently, neurologists had relatively few tools at their disposal to help migraine patients. The treatment landscape has evolved considerably in recent years, explains Alexander Feoktistov, a neurologist at the Synergy Integrative Headache Center in Chicago. “I’ve been in this field of headache medicine for probably over 20 years now, and I’ve never been as excited to work in this field as in the past few years,” he said.

The most recent article in a two-part interview with Dr. Feoktistov (the first part is here) discusses both drug and device treatments for migraine headaches, which affect roughly one billion people globally.

Get the full story from our sister site, MassDevice. 

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