Lilly Launches REYVOW™ (lasmiditan), the First and Only 5-HT1F Agonist for Acute Migraine Treatment in Adults

February 06, 2020 News /Bio ValleyBIOON/ --Eli Lilly(Eli Lilly) recently announced the launch of Reyvow (lasmiditan) C-V 50 mg and 100 mg tablets in the U.S. market. This oral prescription medication is indicated for the acute treatment of migraine with or without aura in adults. It should be noted that Reyvow is not intended for the prophylactic treatment of migraine. The drug is available in 50 mg, 100 mg, and 200 mg strengths, allowing for flexible dosing as needed.

Reyvow was approved by the U.S. FDA in October 2019, representing the first new class of acute migraine treatment medications approved by the FDA in over 20 years. This drug isFDAThe first and only approved 5-HT1F receptor agonist, which acts on both the central and peripheral nervous systems, with a mechanism of action distinct from other currently marketed acute migraine treatments.

In clinical studies, a single dose of Reyvow rapidly and completely eliminated migraine pain and its most bothersome symptoms (nausea, photophobia, or phonophobia) in just 2 hours. United StatesFDAThe recently issued guidelines by the American Headache Society have raised clinical standards, recommending migraine medicationsClinical TrialsThe efficacy must be proven to eliminate pain and the most bothersome symptoms, not merely to alleviate pain. Reyvow isFDAThe first approved acute migraine treatment drug meeting this new standard。

Migraine is a common chronic neurovascular disorder characterized by recurrent, severe headaches, typically unilateral. Currently, there are no medications that can cure migraine. The World Health Organization (WHO) has listed migraine as one of the top 10 most disabling diseases worldwide.

The active pharmaceutical ingredient of Reyvow is lasmiditan, an oral, centrally penetrating, selective serotonin 1F (5-HT1F) receptor agonist that is structurally and mechanistically distinct from currently approved migraine medications and lacks vasoconstrictive activity. Notably, lasmiditan is the first and only approved drug molecule in the “ditan” class for the acute treatment of migraine in adults. This approval represents the first major innovation in acute migraine therapy in over two decades.

Like other drugs with central nervous system (CNS) activity, the FDA requires abuse potential studies for Reyvow. Abuse potential refers to the likelihood of abuse occurring with specific drug products or substances that have CNS activity. Compared withFDAconsistent with the guidelines,Eli LillyA human abuse potential assessment was conducted; as part of the assessment, Reyvow at therapeutic doses was associated with less drug liking compared with alprazolam, but more than placebo.

The approval of Reyvow was based on data from two Phase III studies (SAMURAI and SPARTAN). These studies evaluated the efficacy and safety of Reyvow for the acute treatment of migraine and both met their primary and key secondary endpoints. In both studies, compared with the placebo group, a significantly higher proportion of patients in the Reyvow treatment group achieved complete resolution of migraine pain within 2 hours after the initial dose, and a significantly higher proportion reported complete resolution of their most bothersome symptom (MBS, selected by patients from among nausea, photophobia, or phonophobia). Treatment-emergent adverse events in the studies were generally mild to moderate in severity; the most common adverse events included dizziness, fatigue, paresthesia (tingling or numbness of the skin), sedation, nausea and/or vomiting, and muscle weakness.

Reyvow’s Phase III development program involved more than 4,000 patients and treated over 20,000 migraine attacks. The program also included the open-label GLADIATOR study.

In the treatment of headaches,Eli LillyOne product has already been launched. The company’s antibody drug, Emgality (galcanezumab-gnlm) 120 mg injection, was approved by the U.S. FDA in September 2018 for the preventive treatment of migraine in adults. In June 2019, Emgality received further FDA approval for the treatment of episodic cluster headache (ECH) in adults to reduce attack frequency. Notably, this approval made Emgality the first and only medication indicated for the treatment of ECH. The drug is alsoFDAThe first and only calcitonin gene-related peptide (CGRP) antibody approved for the treatment of two different headache disorders.

In terms of acute treatment for migraine, Allergan’s product Ubrelvy (ubrogepant) was approved by the U.S. FDA in December 2019 for the acute treatment of migraine (with or without aura) in adults. Notably, Ubrelvy is the first and onlyFDAOral Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonists Approved for the Treatment of Migraine Attacks. (Bioon.com)

Original Source: Lilly's REYVOW™ (lasmiditan) C-V, the First and Only Medicine in a New Class of Acute Treatment for Migraine (ditan), Now Available for Prescription