FDA approves Qulipta for prevention of migraine – AbbVie

The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the Phase III ADVANCE study, a Phase II/III efficacy, safety, and tolerability study, and a Phase III long-term safety study. In the pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial, 910 […]

BioDelivery Sciences International completes acquisition of Elyxyb for acute migraine treatment in the U.S. and Canada

BioDelivery Sciences International, Inc. a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced that it has completed the acquisition of U.S. and Canadian rights to Elyxyb (celecoxib oral solution) from Dr. Reddy’s Laboratories Limited. Elyxyb is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. […]

FDA approves Trudhesa nasal spray for the treatment of acute migraine – Impel Neuropharma

Impel NeuroPharma, Inc. announced that the FDA approved Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. Trudhesa was previously known as INP 104. Using Impel’s proprietary Precision Olfactory Delivery (POD ) technology, Trudhesa gently delivers dihydroergotamine mesylate (DHE)—a proven, well-established therapeutic—quickly to the bloodstream through the vascular-rich […]