The FDA recently approved a new drug called Zavzpret (zavegepant) for the acute treatment of migraine headaches with or without aura in adults. This marks an exciting development in the field of migraine treatment, as Zavegepant is the first calcitonin gene-related peptide provided in a nasal spray formulation.
Zavegepant works by blocking the activity of a protein called calcitonin gene-related peptide (CGRP), which is believed to play a key role in the development of migraine headaches. By targeting this specific pathway, Zavegepant provides a new option for patients who have not responded to other treatments (such as triptans or ditans), or who experience side effects from their current medications.
Clinical Trials
The approval of Zavegepant is based on the results of two clinical trials involving over 1,400 patients with moderate to severe migraine headaches. In both studies, Zavegepant was shown to be effective at reducing pain and other symptoms compared to placebo, with many patients experiencing relief within just 15 minutes of taking the drug. Zavzpret also significantly improved:
- Pain relief at 2 hours (59% vs 50%)
- Ability to function normally
- at 2 hours (36% vs 26%)
- at 1 hour (20% vs 16%)
- at 30 minutes (11% vs 6%)
- Sustained pain relief 2-24hrs (41% vs 33%)
Patient Population
Zavzpret was studied at 94 sites in the United States in adults that had at least a one year history of migraine that had onset before age 50. The main exclusion criteria were any history of alcohol or drug misuse (including cannabis) or current pregnancy. A full breakdown of inclusion and exclusion criteria is available in the study.
Adverse Effects
The most common adverse effect was abnormalities in taste from the nasal spray, which is not uncommon among nasally administered drugs. Otherwise, Zavzpret was very well tolerated in its trials.
Cost
Pfizer has not yet released pricing information regarding Zavzpret, but expects the drug to be available in July of 2023. Current CGRP receptor antagonists are extremely expensive, with Ubrelvy (ubrogepant) listed at $118 per tablet and Nurtec (rimegepant) listed at $142 per tablet.
Zavzpret Conclusion
In conclusion, the FDA approval of Zavzpret (zavegepant) provides a new CGRP receptor antagonist option for the acute treatment of migraine headaches in adults. This is especially beneficial for patients who have not responded well to other treatments or have experienced side effects from their current medications. The clinical trials showed that Zavzpret was effective at reducing pain and other symptoms compared to placebo, with many patients experiencing relief within 15 minutes of taking the drug. Additionally, Zavzpret was well-tolerated in its trials, with the most common adverse effect being abnormalities in taste from the nasal spray. Above all else, the rapid onset from a CGRP receptor antagonist nasal spray formulation is a considerable benefit that will help patients achieve more immediate relief.
Are you up to date on the new SGLT2i? Make sure to check out our article on Brenzavvy (bexagliflozin)