Impel NeuroPharma Enters Migraine Market With FDA Nod for Nasal Spray

By Reuters Staff

September 08, 2021

(Reuters) - Impel NeuroPharma Inc said on Friday the U.S. health regulator had approved its nasal spray to treat migraine, marking the drug developer's entry into a market crowded with oral and intravenous medications.

Shares of the company, which made its Nasdaq debut in April, rose about 21% to $27.98 in morning trade after having touched a record peak earlier in the session.

Impel said its drug, Trudhesa, can be self-administered to the bloodstream by being sprayed in the upper part of the nasal canal.

In a late-stage trial, two-thirds of 360 patients with migraine had pain relief two hours after being treated with Trudhesa, Impel said.

The treatment was formulated using dihydroergotamine, a fungi-produced compound that tightens blood vessels in the brain and also forms the basis for many triptans, a class of drugs commonly prescribed for treating acute migraine and cluster headaches.

The company said it plans to commercially launch Trudhesa in early October, hoping it stands out from rival treatments including Biohaven Pharmaceutical's Nurtec ODT and AbbVie Inc's Ubrelvy, which are administered orally.

Historically, there have not been enough effective migraine treatments that are not oral medicines, which cause challenges due to symptoms such as nausea and vomiting attached to the condition, said Kevin Lenaburg, executive director of the Coalition for Headache and Migraine Patients.

The FDA, however, has attached a strict warning to Impel's therapy, saying it carries risks of potential impaired blood supply to the tissues when used in combination with certain enzyme inhibitors in steroids.

Around 39 million Americans and 1 billion people worldwide suffer from migraines, according to the Migraine Research Foundation.

Amneal Pharmaceuticals Inc is also developing a migraine therapy, based on the same compound used by Impel, which can be administered by self-injection.