Biohaven prepares for FDA approval of its second migraine drug following positive phase III results

USA – In a late-stage study, Biohaven Pharmaceutical’s intranasal spray for migraine relief helped relieve pain in as little as 15 minutes and met the main goals, paving the way for the company to file for approval in the United States next year.

In the trial, which included just over 1400 adults with a history of migraine, pain relief lasted for 48 hours after a single intranasal dose of the drug, zavegepant, according to the drugmaker.

A single dose of zavegepant spray was tested against placebo as an acute treatment for a moderate or severe migraine attack in the Phase 3 trial, which enrolled just over 1,400 people with a history of migraine.

According to Biohaven, the results showed that zavegepant met both of the trial’s primary goals, outperforming placebo in terms of pain relief and freedom from the most bothersome symptoms such as nausea or sensitivity to light or sound after two hours.

Notably, the findings appeared to show that zavegepant worked quickly, with a benefit over placebo as early as 15 minutes and lasting pain relief for one to two days.

Nurtec ODT, an oral migraine drug developed by Biohaven, is already approved in the United States for both treatment and prevention.

It competes in a crowded migraine therapy market with drugs such as AbbVie’s orally administered Ubrelvy and Impel NeuroPharma’s recently approved nasal spray, Trudhesa.

Nurtec will be the preferred medication for regular use as a first-line therapy, but zavegepant will play an important role in cases where people require immediate relief, according to Biohaven Chief Executive Officer Vlad Coric.

We want them (patients) to be able to have multiple tools in their tool kits to fight migraine and customise their response,” Coric added.

Previously, a mid-to-late stage trial of the drug evaluating the same main goals yielded similar results.

Patients' preference

The company anticipates that zavegepant, as an intranasal treatment, will be preferred by people who want to avoid the gastrointestinal side effects seen in a small percentage of Nurtect ODT clinical trials, as well as Lilly and AbbVie’s oral migraine medications.

Biohaven, on the other hand, hasn’t had as much success in clinical development outside of migraine.

Late-stage studies of experimental medicines for anxiety disorder, Alzheimer’s disease, and multiple system atrophy have failed in the last two years, reducing the company’s pipeline, as reported by Biopharmadive.

In recent years, the migraine field has become increasingly competitive, and just last month, another new drug entered the fray. Qulipta, an oral CGRP drug developed by AbbVie, has been approved by the FDA as a preventive measure.

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