US FDA approves Amneal’s self-administered migraine treatment
The U.S. Food and Drug Administration has approved Amneal Pharmaceuticals’ (AMRX.O), opens new tab self-administered migraine drug, giving way to a quick and more convenient treatment option for patients.
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.
Migraine, characterized by recurrent attacks of throbbing pain on one side of the head, causes symptoms such as nausea, vomiting and sensitivity to light.
The treatment offers a beneficial alternative to those who respond poorly to oral therapies, Amneal said.
Oral migraine treatments include Axsome Therapeutics’ <AXSM.O> recently approved Symbravo and Pfizer’s (PFE.N), opens new tab Nurtec ODT.
Pfizer also sells a nasal spray, Zavzpret, for the treatment of acute migraine.
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.
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.
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.
