Zavzpret (active ingredient – vegepant) – the first and only nasal spray intended for migraine adults treatment, was recently approved by the FDA. Pfizer announced this on March 10, 2023. It is a calcitonin gene-related peptide (CGRP) receptor antagonist. The drug is intended for treatment of adult patients with migraine with or without aura.

CGRP receptor antagonists are already available as tablets for migraine treatment, but it is often not possible to take a tablet due to severe nausea or vomiting during a migraine attack. In addition, the pills do not act quickly enough to quickly relieve the patient of painful symptoms.

In th trial’s pivotal phase III, vegepant was statistically significantly superior to placebo in terms of pain relief and the most distressing symptoms of migraine with and without aura at 2 hours post-application. The trial also demonstrated pain relief after 15 minutes compared to placebo.

The FDA approval is based on the results of two key studies that established the efficacy, tolerability and safety profiles of vegepant for patients with a migraine attack treatment. In these trials, vegepant was statistically significantly superior to placebo on the primary endpoints of no pain (defined as a reduction in severity of moderate or severe headache to no headache) and no most distressing symptoms 2 hours after a dose of the drug (defined as the absence of a symptom that worries the most).

The stud’s pivotal phase III also demonstrated a statistically significant benefit over placebo for 13 of 17 predefined secondary endpoints, including time to onset of effect (for instance, pain relief at 15 and 30 minutes) and return to normal activities (after 30 minutes, after 2 hours) and long-term efficacy endpoints (for example, long-term pain relief).

Zavegepant was well tolerated in clinical trials. The most common side affects reported in 2% of patients, and with a frequency higher than placebo, were taste disturbances, nausea, nasal discomfort, and vomiting.

The drug is contraindicated in patients with hypersensitivity to vegepant or any of its components. Drug application during clinical trials, there were such reactions as hypersensitivity, including swelling of the face and urticaria.

Zavzpret is expected to reach pharmacies in late summer 2023.