Benzinga | Jun 7, 2021 08:07AM EDT

Amneal Announces Dihydroergotamine (DHE) Autoinjector NDA For Migraines And Cluster Headaches

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) ("Amneal" or the "Company") today announced that the Food and Drug Administration recently accepted Amneal's 505(b)(2) New Drug Application for a newly licensed dihydroergotamine (DHE) prefilled syringe autoinjector and the company said it anticipates a decision by the middle of 2022. If approved, Amneal anticipates a commercial launch in the second half of 2022. Amneal plans to commercialize the product solely in the U.S. market.

"The addition of the DHE autoinjector reflects our commitment to expand our Specialty portfolio by bringing impactful therapies that deliver differentiated value for patients in need," said Joseph Todisco, Chief Commercial Officer for Amneal Specialty. "We plan to leverage our existing commercial infrastructure in Neurology and experience in the migraine and headache space to bring this product to market."

The proposed indication for the product is acute migraine with and without aura and cluster headache in adults. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. Currently, DHE is also available both as ampules for injection or as a nasal spray formulation for at-home use. This product would allow patients to self-administer DHE via a single-dose, ready-to-use autoinjector pen without the need for assembly.

Over 39 million Americans are living with migraine(1), and up to one million with cluster headache.(2) Headache is the fourth most common reason for emergency department visits, and accounts for 3% of all ER visits in the United States.(3)

According to IQVIA(tm), a leading healthcare data and analytics provider, U.S. annual sales for all forms of DHE for the 12 months ended March 2021 were approximately $70 million.