On January 26th, Pfizer announced that its new generation of specific migraine treatment drug, Rimezepam orally disintegrating tablets, has been approved by the National Medical Products Administration for the acute treatment of migraines in adults with or without aura. It is reported that this is a calcitonin gene related peptide (CGRP) receptor antagonist that uses orally disintegrating tablet technology. It can effectively block the key pathways related to the onset of migraine, quickly and continuously relieve headaches and related accompanying symptoms. It is easy to take and has no cardiovascular disease taboos or other effects.
Migraine is a common chronic disease, and the World Health Organization (WHO) lists it as one of the 10 most disabling internal medicine diseases. The typical feature of this disease is intermittent attacks that last for 4 to 72 hours, and may cause moderate to severe pulsatile headaches such as nausea, vomiting, fear of sound, and photophobia. At present, the common drugs for acute treatment of migraines are tratans. However, these drugs have side effects that cause vasoconstriction, so patients at risk of cardiovascular disease cannot use these drugs.
Remazepam sulfate orally disintegrating tablets were approved for marketing by the US FDA in 2020 for the acute treatment of adult migraine attacks. According to an earlier press release from Biohaven, this is the first CGRP receptor small molecule antagonist with a rapid oral disintegration tablet form. In 2021, the product was once again granted FDA expanded indications for the preventive treatment of episodic migraines (with less than 15 migraine attacks per month). In May 2022, Pfizer spent approximately $11.6 billion to acquire Biohaven to expand its migraine product pipeline, in order to acquire this product.
According to a Pfizer press release, Rimezepam orally disintegrating tablets are the first oral CGRP receptor antagonist to show positive results in a key trial in China. In this study, patients achieved the common primary endpoint of pain and most troubled symptom relief after a single oral dose of 75mg of medication for 2 hours. Patients can quickly relieve pain and eliminate the most troublesome symptoms within 45 minutes, restore normal function within 60 minutes, and eliminate pain within 90 minutes; For most patients, its sustained efficacy can reach 48 hours, while demonstrating good safety and tolerability, consistent with previous clinical trial results in the United States.