migraine Archives - Medical Design Sourcing

Ear-puffing device for migraine treatment wins FDA breakthrough designation

Nocira’s AVPI migraine treatment device [Photo courtesy of Nocira]

A handheld device that treats migraine attacks with puffs of air in a patient’s ears has been designated a breakthrough device by the FDA.

Tempe, Arizona-baed Nocira said it is the first company to announce breakthrough device designation for treating migraine attacks in both chronic and non-chronic migraine patients ages 18 and up.

The device uses “gentle, controlled puffs of air in the ears” to subtly change pressure in the external ear canal, a drug-free technology that Nocira calls Automated Variable Pulse Insufflation (AVPI).

“This therapeutically stimulates a unique combination of pressure-responsive nerve pathways from the ear into areas of the brain associated with headache pain and other migraine symptoms,” the company said yesterday in a news release.

A smartphone app controls th…

AbbVie shares positive Phase 3 atogepant data to prevent chronic migraine

Gepants have gained ground in recent years as a migraine treatment following the FDA’s approval of Allergan’s Ubrelvy (ubrogepant) in 2019.

Now, AbbVie (NYSE:ABBV) has announced that a Phase 3 study testing Qulipta (atogepant) met its primary endpoint of reducing mean monthly migraine days over placebo.

FDA approved atogepant as a preventive treatment of episodic migraine in adults on September 28, 2021.

The company hopes the data will convince FDA to authorize the expanded use of atogepant as a preventive treatment of chronic migraine.

AbbVie plans on filing a supplemental New Drug Application (sNDA) with the agency.

In the Phase 3 PROGRESS study, both the 60-mg once-daily and 30-mg twice daily versions of the oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met the endpoint over a 12-week treatment period.

In the study, 778 participants shared eDiary headache data. One treatment arm received the …

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 …

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.

Impel NeuroPharma wins FDA approval for migraine nasal spray

(PRNewsfoto/Impel NeuroPharma)

Impel NeuroPharma (NSDQ:IMPL), a biopharma founded in 2008, has won FDA approval for Trudhesa (dihydroergotamine mesylate) nasal spray as an acute migraine therapy.

The Seattle-based company intends to launch the drug, formerly known as INP104, in early October 2021.

Impel plans to price the drug between $600 and $850 for a package with four doses.

The company will make the drug available via a pharmacy partnership and copay program.

Impel NeuroPharma is using proprietary technology that it has dubbed Precision Olfactory Delivery (POD). The delivery method supports the delivery of dihydroergotamine (DHE) mesylate to the upper nasal cavity, according to the press release.

“The approval of Trudhesa marks the culmination of more than a decade of research and advanced engineering to pair the proven efficacy of DHE with our innovative POD technology,” sai…

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…

This medtech is giving hope to migraine sufferers

[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 1 billion people globally.

Get the full story from our sister site, MassDevice.

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.