Biohaven lines up rhinosinusitis patients for trial of its migraine med Nurtec ODT

Even in a crowded field full of formidable competitors, Biohaven has set itself apart with migraine medication Nurtec ODT just two years after it was approved.

Now the company has another indication in mind for the treatment: rhinosinusitis.

On Tuesday, Biohaven revealed that it is lining up participants for a phase 2/3 trial of Nurtec in those with chronic rhinosinusitis, or CRS, regardless of whether they have nasal polyps.

With Nurtec working as a calcitonin-gene related peptide receptor antagonist, Biohaven believes the drug may have applications for treating the disorder which causes inflammation of the nasal and sinus cavities. It usually is treated with corticosteroids.

“CGRP is hypothesized to play a role in the pathophysiology of sinus congestion and pain,” Daniel Franjic, Biohaven’s medical director, said in a release. “We are excited to explore the potential of a novel therapeutic option for patients.”

CRS affects between 5-12% of the general population, Biohaven said, with inflammation lasting at least 12 weeks. Approximately 20% of those with CRS develop nasal polyps.

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The company expects to enroll 200 patients at 25 sites in the U.S. The primary outcome measure is the change in a patient’s level of facial pain, pressure and fullness on a scale of 0-10.

“Patients with CRS have few medical options,” Gary Berman, clinical assistant professor at the University of Minnesota, said in the release. “Nurtec ODT may offer a new therapeutic choice.”

Nurtec saw immediate success after its approval in February of 2020, providing an oral alternative to injected treatments Aimovig (Amgen), Emgality (Lilly) and Ajovy (Teva). Additionally, Nurtec established its niche to treat acute migraine and prevent it, while the others are solely preventative. While fourth-quarter results are still pending, Biohaven estimates its sales came in at $462 million last year. 

In September of last year, AbbVie gained approval for its oral CGRP migraine drug, Qulipta.

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In addition to rhinosinusitis, Biohaven is exploring (PDF) Nurtec’s effectiveness against trigeminal neuralgia and nonmigraine indications such as psoriasis, soon to enter phase 2 testing, according to an investor presentation earlier this month.

Biohaven has another CGRP drug, Zavegepant, which is in phase 3 testing for migraine and is entering a phase 2 study in COVID-19 and asthma treatment.