Tag: migraines

Categories : Pain ManagementTags :

New Migraine Prevention Drug Gets The Green Light from FDA

On By ModernMedia
Source: Usman Yousaf on Unsplash

Atogepant (Qulipta) has become the first oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for migraine prevention to win FDA approval, manufacturer AbbVie announced on Monday.

Following on after rimegepant, which is also indicated by the FDA for acute migraine treatment, atogepant became the second gepant approved for prevention of episodic migraine in adults.

The atogepant decision “reflects a broader shift in the treatment and management paradigm for the migraine community,” noted Peter Goadsby, MD, PhD, DSc, of the University of California Los Angeles and King’s College London.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” said Dr Goadsby in a statement.
Atogepant has a high affinity at the CGRP receptor, and being a small-molecule drug it can be taken orally, unlike injectable anti-CGRP monoclonal antibodies approved for migraine prevention.
An oral CGRP-receptor antagonist is easier for patients, Goadsby noted when he presented data from atogepant’s pivotal phase IIb/III trial at the 2019 American Academy of Neurology annual meeting. “It could facilitate, with time, the greater use of this mechanism in primary care,” he told MedPage Today. “Primary care doctors will more easily use a medicine that’s relatively simple to use and well-tolerated, and that means more migraine patients can get treated.”

In the phase III ADVANCE trial, 873 participants were randomised to receive a once-daily dose of oral atogepant (10mg, 30mg, or 60mg) or placebo. After 12 weeks, average days with migraine per month dropped from baseline by 3.7 days with atogepant 10mg, 3.9 days with atogepant 30mg, 4.2 days with atogepant 60mg, and 2.5 days with placebo. The most common adverse events with atogepant were constipation and nausea, along with fatigue. 
Patients should notify their healthcare provider if they have kidney problems or are on dialysis, have liver problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed, AbbVie said.

Source: MedPage Today

Categories : Medical IndustryTags :

Novel Nasal Spray for Migraines Approved by FDA

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Impel NeuroPharma announced that the US Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults.

The innovative system delivers dihydroergotamine mesylate (DHE) through the vascular-rich upper nasal space, bypasses the gut and potential absorption issues, offering rapid, sustained, and consistent symptom relief without injection or infusion, even when administered hours after a migraine attack starts. 

During the Phase 3, open-label, pivotal safety study, STOP 301, more than 5,650 migraine attacks were treated over 24 or 52 weeks during the study. The primary objective of the study was to assess the safety and tolerability of TRUDHESA. TRUDHESA was generally well tolerated and exploratory efficacy findings showed it provided rapid, sustained, and consistent symptom relief. STOP 301 reported TRUDHESA offered consistent efficacy even when taken late into a migraine attack.

“Many of my patients need more from their migraine treatment, and TRUDHESA offers a non-oral, fast-acting, reliable option that overcomes many current medication challenges,” said Stephanie J. Nahas-Geiger, MD, MSEd, Associate Professor in the Department of Neurology, and Program Director of the Headache Medicine Fellowship Program, Thomas Jefferson University. “Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments. And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack, so patients don’t need to worry about missing the opportunity to benefit from using TRUDHESA within a certain timeframe. I think patients will be very receptive to this treatment, because it pairs the long-proven benefits of DHE with a patient-friendly delivery system.”

There were no serious adverse events were observed in the study, and most adverse events were mild and transient in nature.

In the STOP 301 study, patient-reported efficacy showed that 38% of patients had pain freedom, 66% had pain relief, and 52% had freedom from their most bothersome migraine symptom at two hours after their first dose of TRUDHESA. In 16% of patients, pain relief started as early as 15 minutes. Of patients who were pain free at two hours, 93 percent were still pain free at 24 hours, and 86 percent were still pain free through two days. The great majority of patients (84%) reported that TRUDHESA was easy to use10 and preferred it over their current therapy.

Source: Impel NeuroPharma