First Nasal Spray CGRP Inhibitor Approved

Pfizer's migraine treatment Zavzpret (active ingredient: zavegepant) was officially marketed on March 9, 2023, after receiving final approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA). Zavzpret is the first and only nasal spray formulation in the calcitonin gene-related peptide (CGRP) receptor antagonist class for the acute treatment of migraine. Unlike existing oral migraine treatments, which can be difficult for patients experiencing nausea or vomiting to take, Zavzpret delivers medication directly through the nasal route, effectively overcoming gastrointestinal-related side effects. This addresses a significant unmet clinical need, as many migraine patients experience severe nausea and vomiting during acute attacks.

Efficacy Verified Through Pivotal Phase 3 Data

The FDA approval of Zavzpret was based on results from the pivotal Phase 3 trial (NCT04571060), published in The Lancet Neurology. In the trial, 23.6% of patients who received 10mg of Zavzpret achieved complete freedom from migraine pain within two hours, a statistically significant improvement compared to 14.9% in the placebo group (P<0.0001). Additionally, 39.6% of patients achieved freedom from their most bothersome symptom (MBS Freedom), compared to 31.1% in the placebo group (P=0.0012). Notably, the drug demonstrated a rapid onset of action within just 15 minutes of administration, with effects lasting up to approximately 48 hours, confirming its strong clinical efficacy.

Completion of Pfizer's Migraine Portfolio via Biohaven Acquisition

Originally a core pipeline product of Biohaven Pharmaceutical, Zavzpret became part of Pfizer's portfolio following the company's $11.6 billion (USD) acquisition of Biohaven in October 2022. As part of the deal, Biohaven's existing CGRP pipeline was transferred to Pfizer, while its non-CGRP pipeline was spun off into a new entity, 'New Biohaven.' New Biohaven has entered into a commercial agreement to receive sliding-scale royalties if the combined annual sales of Nurtec ODT and Zavzpret in the U.S. exceed $5.25 billion. With the approval of Zavzpret, Pfizer now complements its flagship oral CGRP inhibitor, Nurtec ODT (active ingredient: rimegepant), to form a dominant migraine portfolio.

Differentiation Strategy in a Competitive CGRP Market

The global migraine treatment market is projected to grow rapidly, reaching between $7 to $8.4 billion by 2026 and potentially approaching $20 billion within the next decade. In this fast-growing market, strong oral competitors such as AbbVie's Ubrelvy (active ingredient: ubrogepant) and Nurtec ODT already hold significant market share. However, Pfizer is leveraging its unique nasal spray drug delivery technology to capture a niche market for patients seeking rapid therapeutic effects. The speed and convenience of the nasal spray formulation enhance the drug's value, and Pfizer's existing marketing network will help maximize its commercial potential.