2023-02-18| Trials & Approvals

Pfizer Trumpets Lancet Publication Of Migraine Drug’s Phase 3 Results

by Joy Lin
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Pfizer has announced the publication of Phase 3 results for zavegepant, an investigational nasal spray for acute migraine, in The Lancet Neurology. The study met its co-primary endpoints, showing that zavegepant brings quick and durable pain relief as well as relief from the most bothersome symptom (MBS). 

“This was the first Phase 3 clinical trial of a non-oral CGRP receptor antagonist developed for the acute treatment of migraine in adults,” said Richard B. Lipton, M.D., Lead Author, Department of Neurology at the Albert Einstein College of Medicine.

“With this evidence of sustained treatment benefits, good tolerability and an alternative administration method, I believe zavegepant has the potential to fill an important gap in the available options for the acute treatment of migraine.”

Zavegepant was one of several CGRP assets, including the approved Nurtec (rimegepant), netted from Pfizer’s $11.6 billion acquisition of Biohaven Pharmaceuticals last year.  

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Zavegepant Showed Better Symptom Relief Versus Placebo

Zavegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist. This class of antagonists offers an alternative to other migraine drugs, particularly for patients contraindicated to the use of triptans (such as Relpax or Amerge) or those who have poor response or intolerance to them. 

In the study, zavegepant met its co-primary endpoints, showing that a single 10 mg dose was more effective than placebo for pain freedom (24% vs 15%) and freedom from the most bothersome symptom (MBS) (40% vs 31%) at two hours after dosing. Nausea, photophobia, and photophobia are commonly reported MBSs. 

Additionally, the drug demonstrated relief from migraine pain in 15 minutes, with relief lasting up to 48 hours for many patients. Participants reported two to eight moderate or severe migraine attacks per month, and untreated attacks lasted an average of over 30 hours. Zavegepant treatment was also associated with higher rates of return to normal functional ability at 30 minutes post treatment and two hours.

While well-tolerated in most patients, common side effects include an altered sense of taste (20.5%), nasal discomfort (3.7%), and nausea (3.2%). The safety profile of zavegepant was consistent with earlier studies, and there no liver toxicities were identified.

“The  results from this study demonstrate zavegepant’s potential as an effective acute nasal spray treatment for migraine, a neurological disorder that affects more than one billion people worldwide,” said Lipton.

Pfizer has filed zavegepant for regulatory approval with the US FDA for the acute treatment of migraine in adults. The review for the approval filing is expected to be completed in the first quarter of 2023. 

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