The Lancet has published Phase 3 study results for zavegepant, an investigational nasal spray for the acute treatment of migraine. The study found that a single 10 mg intranasal dose of zavegepant was more effective than placebo for pain relief and freedom from the most bothersome symptom at two hours post-dose.

Zavegepant is a small molecule calcitonin gene-related peptide (CGRP) receptor antagonist. CGRP is a protein involved in transmitting pain signals in the brain.

Zavegepant’s nasal formulation could be particularly valuable for migraine patients who experience nausea and difficulty swallowing.

Zavegepant is now a Pfizer asset

Pfizer (NYSE:PFE) acquired the asset through last year’s purchase of Biohaven Pharmaceutical Holding Company (NYSE:BHVN), which had commercialized the dual-acting migraine therapy Nurtec ODT (rimegepant).

In the recent Phase 3 study of zavegepant, the novel CGRP receptor antagonist provided relief from migraine pain within 15 minutes, with effects lasting up to 48 hours for many patients. The drug was well-tolerated, and investigators received no reports of serious adverse events.

The study authors note that further trials would be needed to determine the drug’s long-term safety and its consistency in managing future migraine attacks.

Bristol-Myers Squibb initially discovered the drug.

Biohaven filed a new drug application (NDA) for zavegepant in early 2022. FDA could approve the drug in the first quarter of 2023.

Annual sales could surpass $200M by 2030

Annual U.S. sales of zavegepant could reach $206.8 million by 2030, according to GlobalData. In addition, the analyst firm noted that zavegepant’s intranasal formulation could provide a competitive advantage, especially for patients with migraine-related nausea and dysphagia who cannot take oral gepants such as AbbVie’s Ubrelvy (ubrogepant) or Biohaven’s Nurtec (rimegepant). The firm noted, however, that key opinion leaders (KOLs) it interviewed expressed concerns about the drug candidates’ side effects inherent to nasal sprays. The KOLs also raised questions about its reimbursement.

Roughly 40 million people in the U.S. suffer from migraines. About one billion people worldwide have the condition.

CGRP receptor antagonists have emerged as an important treatment option for migraine patients, but the market for the drugs has become increasingly crowded over the past five years. Notable medications in the class include the following:

• Aimovig (erenumab): Developed by Amgen and Novartis, erenumab became the first CGRP antagonist to win FDA approval as a preventive treatment of migraine in adults in 2018.
• Emgality (galcanezumab): Lilly’s galcanezumab won FDA approval in 2018 as a preventative treatment for migraines. A year later, it won approval for episodic cluster headaches.
• Ajovy (fremanezumab): Developed by Teva Pharmaceuticals, fremanezumab won FDA approval in 2018. Teva received approval for an Ajovy autoinjector two years later.
• Qulipta (atogepant): The CGRP antagonist from AbbVie won FDA approval in 2021.

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Filed Under: Neurological Disease
Tagged With: zavegepant
 

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