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…
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…
Why Impel NeuroPharma is targeting the migraine market
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…
Impel NeuroPharma wins FDA approval for migraine nasal spray
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.…
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…
Elyxyb remains a novel migraine therapy
Last year, FDA approved the celecoxib oral solution Elyxyb from Dr. Reddy’s Laboratories as an acute treatment of migraine with or without aura in adults. Formerly known as DFN-15, Elyxyb is a novel selective inhibitor of cyclooxygenase-2. The company received FDA approval for the drug in May 2020. The company formulated the drug as an oral solution…
Reyvow indicated for treating migraines
Reyvow (lasmiditan) is an FDA-approved treatment from Lilly for the acute treatment of migraine with or without aura in adults. FDA has not approved it as a preventive treatment of migraine. In October, Lilly announced that the drug showed superior pain freedom after two hours of ingestion in two-thirds of migraine attacks in a Phase…
Nurtec ODT wins approval as a preventive treatment of migraine
FDA indicates Biohaven Pharmaceuticals‘ Nurtec ODT for the acute treatment of migraine with or without aura in adults. The agency recently extended the indication to include the preventive treatment of migraines. Nurtech is currently the only drug to win FDA approval as both an acute and preventive migraine treatment. The expanded indication has launched the…
Meet the drugs and devices giving hope to millions of migraine patients
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…