US FDA approves Amneal's self-administered migraine treatment

- 5/15/2025

</head><body><p>(Reuters) -The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals' self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.</p><p>The treatment, branded as Brekiya, delivers a single dose of the drug called dihydroergotamine mesylate via an autoinjector. It is approved for the treatment of acute cases of migraine and severe, one-sided pain in the head called cluster headaches in adults, the drugmaker said on Thursday.</p><p>Migraine, characterized by recurrent attacks of throbbing pain on one side of the head, causes symptoms such as nausea, vomiting and sensitivity to light. </p><p>The treatment offers a beneficial alternative to those who respond poorly to oral therapies, Amneal said.</p><p>Oral migraine treatments include Axsome Therapeutics' <AXSM.O> recently approved Symbravo and Pfizer's Nurtec ODT.</p><p>Pfizer also sells a nasal spray, Zavzpret, for the treatment of acute migraine.</p><p>Amneal's single-dose drug can be administered by patients into the middle of the thigh and does not require refrigeration or assembly of the device.</p><p>Brekiya will be available in the U.S. by the second half of the year and Amneal will disclose price details close to the launch, it said.</p><p>The FDA had previously declined to approve the application citing issues at a third-party manufacturing site. The company said last year it had transferred production to an in-house facility. </p><p> (Reporting by Mariam Sunny and Puyaan Singh in Bengaluru; Editing by Devika Syamnath)</p></body></html></p> <div id="news-wrapper"> <div class="thumbnail additional-resources client-content-image-box"> <div class="box-image" style="background-image: url(/images/home/news.jpg);"></div> <div class="caption"> <h3>Nationwide News</h3> <div> <p><a href='/mh/news-article-detail.aspx?id=155564'>NJ AG investigating after Fort Lee police shoot woman in ‘mental health crisis’</a></p> <p><a href='/mh/news-article-detail.aspx?id=155555'>How understaffing, mental health failures led to ‘mounting crisis’ in Richland County jail</a></p> <p><a href='/mh/news-archive.aspx'>News Archive</a></p> </div> </div> </div> </div> </div> </div> </div> </section> </div>  <footer class="footer">  <div class="clearfix footerInfo"> <div class="container"> <div class="row"> <div class="col-sm-7 col-xs-12"> <div class="footerText"> <a href="http://www.trilogyir.com/" target="_blank" class="footerLogo"><img src="/images/Noc-Logo-white.png" alt="Footer Logo" style="width: 200px;"></a> <div class="genericContent" id="landingPageText"> <p>The Network of Care for Mental/Behavioral Health is an online information portal for individuals, families and social service agencies concerned with community mental health services, substance use treatment programs and help for people with developmental disabilities.</p> </div> <h3 id="lblTechAssistance" style="color: #fff; 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US FDA approves Amneal's self-administered migraine treatment