20 years of major innovation! Lilly 5-HT1F agonist reyvow is on the market in the United States, the first new type of acute migraine treatment drug!

February 6, 2020 / BIOON / -- Eli Lilly recently announced the launch of reyvow (lasmiditan) C-V 50mg and 100mg tablets in the U.S market, which is an oral prescription drug for adults with or without aural symptoms of migraine It should be noted that reyvow is not suitable for the prophylactic treatment of migraine The dosage specifications of the drug are 50mg, 100mg and 200mg, which can be flexibly selected according to the needs Reyvow was approved by FDA in October 2019, representing the first new type of acute migraine treatment drug approved by FDA in more than 20 years The drug is the first and only 5-HT1F receptor agonist approved by FDA It can act on both central and peripheral nerves Its mechanism is different from other acute migraine drugs on the market In clinical research, reyvow can eliminate migraine pain and its most annoying symptoms (nausea, light sensitivity or voice sensitivity) quickly and completely in only 2 hours Recent guidance from the FDA and the American Headache association has raised clinical standards, suggesting that clinical trials of migraine drugs need to prove the efficacy of eliminating pain and the most annoying symptoms, not just pain relief Reyvow is the first acute migraine treatment drug approved by FDA to meet this new standard Migraine is a common chronic neurovascular disease, characterized by recurrent severe headache, mostly laterally At present, there is no medicine to cure migraine The World Health Organization (who) has listed migraine as one of the top 10 most disabling diseases The active component of reyvow is lasmiditan, which is an oral, central nervous system permeable, selective, 5-hydroxytryptamine 1F (5-HT1F) agonist It is different from the currently approved migraine drug in structure and mechanism, and has no vasoconstrictive activity It is worth mentioning that lasmiditan is the first and only drug molecule approved for acute treatment of migraine in adults This approval represents the first major innovation in the treatment of acute migraine in more than 20 years Like other drugs with central nervous system (CNS) activity, the FDA requires a study of the abuse potential of reyvow Abuse potential refers to the possibility of abuse of specific drug products or substances with CNS activity In line with FDA guidelines, Lilly conducted an assessment of human abuse potential; as part of the assessment, the therapeutic dose of reyvow was associated with fewer drug preferences than alprazolam, but more than placebo Reyvow's approval is based on data from two phase III studies (samurai, Spartan) These studies evaluated the efficacy and safety of reyvow in the treatment of migraine, and reached the primary and secondary endpoints of the study In both studies, a significantly higher proportion of patients in the reyvow treatment group experienced a complete elimination of migraine pain at 2 hours after the first administration, and a significantly higher proportion reported a complete elimination of their most annoying symptoms (MBS, selected by patients from nausea, light sensitivity or voice sensitivity), compared with the placebo group In the study, the treatment-induced adverse events were generally mild to moderate, and the most common adverse events included dizziness, fatigue, sensory abnormalities (tingling or numbness of the skin), sedation, nausea and / or vomiting, and muscle weakness Reyvow's phase III development involved more than 4000 patients and more than 20000 migraine episodes The project also includes open label Gladiator research In terms of headache treatment, Lilly has a product on the market The company's antibody drug emgality (galcanezumab gnlm) 120mg injection was approved by the US FDA in September 2018 for adult migraine prevention In June 2019, emgality was approved by FDA to treat adult onset cluster headache (ECH) and reduce the frequency of attack It is worth mentioning that this approval makes emgality the first and only drug to treat ECH It is also the first and only anti CGRP antibody approved by FDA to treat two different headache diseases In terms of acute treatment of migraine, ubrogepant, a product of Erjian company, was approved by the US FDA in December 2019 for acute treatment of adult migraine (with or without aura) It is worth mentioning that ubralvy is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved by FDA for the treatment of migraine attack Lilly's reyvow Gamma (lasmiditan) C-V, the First and Only Medicine in a New Class of Acute Treatment for Migraine (ditan), Now Available for Prescription