On March 9th, the FDA approved the first new molecular entity of the month, ZAVEGEPANT (ZAVZPRET), for the treatment of acute migraine. This product is a new type of CGRP inhibitor that can be used to treat migraine with or without aura. It is worth mentioning that this product is the first nasal spray product in the field of CGRP inhibitors, and the purpose of making nasal sprays is to achieve faster efficacy.
In order to obtain FDA approval, Pfizer conducted a two line phase III trial to demonstrate the safety and efficacy of this product. In Experiment 1 (NCT04571060), acute migraine was randomly divided into two groups and treated with a single dose of this product (n=623) or placebo (n=646). The results showed that in the treatment group with this product, 23.6% of patients achieved complete pain free within 2 hours, while the placebo group only achieved 14.9%. In the treatment group of this product, 39.6% of patients experienced disappearance of migraine specific discomfort symptoms (such as photophobia, fear of sound, nausea, etc.), while only 31.1% of patients in the placebo group reached this level. The design of Experiment 2 is similar to Experiment 1, and the experimental results are as follows:
Prior to this, the FDA had already approved multiple CGRP monoclonal antibodies (Erenumab Galcanezumab、Fremanezumab、Eptinezumab）， Multiple small molecule CGRP inhibitors (Ubrogepant Rimegepant、Atogepant）， The competition for this target is particularly fierce, as many analysts' predictions of blockbuster bomb sales have fallen short of expectations. In order to make the drug effective, the previously marketed products were mostly rapid release tablets and oral disintegrating tablets, and the use of nasal spray technology for CGRP inhibitors was the first. However, for the treatment of migraine, nasal spray drug delivery is a very good choice. In addition to this product, Vazegepant is expected to be approved as a nasal spray CGRP product in the future.
