On March 9, the FDA approved ZAVEGEPANT (ZAVZPRET), the first new molecular entity so far this month, for the treatment of acute migraine. This product is a new type of CGRP inhibitor. Whether it is migraine with aura or migraine without aura, it can be used to treat it. It is worth mentioning that this product is the first nasal spray product in the field of CGRP inhibitors.
In order to obtain FDA approval, Pfizer conducted two Phase III trials to demonstrate the safety and effectiveness of the product. In Trial 1 (NCT04571060), acute migraine was randomly assigned to a single dose of NCT04571060 (n=623) or placebo (n=646), and 23.6% of patients in the NCT04571060 group achieved complete pain free at 2 hours, compared to 14.9% in the placebo group. In the treatment group, 39.6% of patients with migraine characteristics of the most unpleasant symptoms (photophobia, fear of sound, nausea, etc.) disappeared, compared with 31.1% of patients in the placebo group. The design of experiment 2 is similar to that of experiment 1, and the test results are as follows:
Prior to this, the FDA has approved several CGRP monoclonal antibodies (Erenumab, Galcanezumab, Fremanezumab, Eptinezumab), as well as several small molecule CGRP inhibitors (Ubrogepant, Rimegepant, Atogepant). The target is particularly competitive, with many analysts predicting blockbuster sales that have missed expectations. In order to make the drug work, most of the products on the market are quick-release tablets and oral collapse tablets, and the CGRP inhibitor using nasal spray technology is the first. However, for the treatment of migraine, nasal spray drug is a very good choice, in addition to this product, the future is expected to be approved nasal spray CGRP product Vazegepant.
