The company said the injection is the first and only dihydroergotamine (DHE) autoinjector for treating migraine and cluster headaches.

Shares of Amneal Pharmaceuticals, Inc. (AMRX) traded marginally higher on Thursday morning after the U.S. Food and Drug Administration (FDA) approved its self-administrable Brekiya injection for treating migraine and cluster headaches in adults.

The autoinjector allows patients to self-administer dihydroergotamine (DHE) without visiting the emergency room. DHE is commonly administered intravenously in emergency rooms, urgent care facilities, and headache clinics.

The autoinjector contains the same medication used in hospitals. Patients can deliver one dose subcutaneously into the middle of the thigh for pain relief. Each autoinjector contains 1mg, or one dose.

According to Amneal, 39 million Americans suffer from migraine and up to one million with cluster headaches.

The company said the injection is the first and only dihydroergotamine (DHE) autoinjector for the treatment of the two conditions.

However, the company warned that the Brekiya autoinjector cannot be used to prevent migraines or treat other types of headaches, such as hemiplegic migraines that make you unable to move on one side of your body.

The autoinjector does not require refrigeration, assembly, or priming of the device and may also help patients who do not respond to oral therapies, the company said. Patients may administer up to 2 more doses after the first dose if the pain does not cease.

Furthermore, the injection is only approved in adults, and it is not known if it is safe or effective in children.

Amneal stock is down by 5% this year but up by over 7% over the past 12 months.

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