The US FDA approval of REYVOW represents the first new class of acute migraine treatment approved in more than two decades
Image: FDA Building 51 houses the Center for Drug Evaluation and Research. Photo: Courtesy of The U.S. Food and Drug Administration/Wikipedia.
US pharmaceutical firm Eli Lilly has secured approval from the US Food and Drug Administration (FDA) for its REYVOW (lasmiditan), as an oral medication for the acute treatment of migraine.
The company claims that its REYVOW has a unique mechanism of action and marks the first and only FDA-approved medicine for acute treatment for migraine in adults with or without aura.
Lilly Bio-Medicines neurology development vice president Gudarz Davar said: “Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack.
“There is a substantial unmet need for new acute treatments for migraine, like REYVOW, which is why we are proud of today’s approval and Lilly’s continuing contribution to the migraine community.
“New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine.”
Human abuse potential assessment for REYVOW showed positive results
The FDA approval of medicines with central nervous system (CNS) activity requires abuse potential studies, where the abuse potential is the possibility of abuse to occur with a particular drug product or substance with CNS activity.
Eli Lilly has carried out a human abuse potential assessment for REYVOW, aligning to the FDA’s guidance.
The company said that the abuse potential evaluation has demonstrated that the therapeutic doses of REYVOW were associated with less drug liking when compared to alprazolam, but more than placebo.
The new drug is planned to be launched for patient use, through retail pharmacies, following the receipt of recommended controlled substance classification, which is currently being reviewed by the Drug Enforcement Administration (DEA).
The DEA controlled substance classification is expected within 90 days of FDA approval.
Lilly Bio-Medicines president and senior vice president Patrik Jonsson said: “For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds.
“The approval of REYVOW is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens.”