Pharma Focus America

Pfizer Discovers Novel Nasal Spray for the Treatment of Migraine

Pfizer has developed ZAVZPRET™ (zavegepant), the first and only new CGRP receptor antagonist nasal spray for the acute management of adult migraines.

The U.S Food and Drug Administration (FDA) has given this spray its approval.

An oral and intranasal formulation of zavegepant, a third-generation, selective, and structurally distinct small molecule CGRP receptor antagonist, is currently undergoing clinical testing.

According to Pfizer, ZAVZPRET considerably outperformed the placebo in its pivotal Phase 3 research on the co-primary goals of freedom from pain and freedom from the most bothersome symptom two hours following treatment. The pivotal study also demonstrated superior pain reduction over a placebo as early as 15 minutes later in a secondary goal that was set.

Zavegepant was discovered to be statistically superior to placebo in 2 important studies that compared the drug with a placebo for the immediate treatment of migraine.

The small molecule CGRP receptor antagonist nasal spray has achieved the co-primary endpoints of relieving moderate to severe headache pain and decreasing patients' most bothersome symptoms two hours after treatment. This drug has demonstrated significant efficacy in relieving headache pain as well as reducing the most bothersome symptoms at two hours post-dose.

Additionally, 76% (13 of 17) of the predetermined secondary outcome measures showed that zavegepant was superior to the placebo. Overtaking the placebo in:

  • Early endpoints of time (relief of pain within 15 to 30 minutes, return to normal function in 30 minutes)
  • After two hours, resume regular activity.
  • Long-lasting efficacy endpoints (sustained pain freedom, sustained pain relief from 2 to 48 hours).

In clinical trials, the nasal spray was similarly well tolerated. The risk of taste disorders such as dysgeusia and ageusia, nausea, stuffy nose, and vomiting (reported in 2% or more of patients) are the most frequent adverse events (AEs). Patients who are hypersensitive to zavegepant or its related components should not take the drug. AEs can cause urticaria and facial edoema.

Zavegepant is anticipated to be available starting in July 2023.

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