Eli Lilly and Company announced REYVOW™ (lasmiditan) C-V 50 mg and 100 mg tablets, an oral medication for the acute treatment of migraine with or without aura in adults, is now available for prescription. REYVOW is a new class of acute treatment for migraine, as it is the first and only FDA-approved ditan, a 5-HT1F receptor agonist, believed to act both centrally and peripherally. REYVOW is available in 50 mg, 100 mg and 200 mg doses for patients, which offers dosing flexibility for physicians and other prescribers.
"As a healthcare professional, I am thrilled that REYVOW is now available. In only two hours and with a single dose, REYVOW has demonstrated the chance for patients to achieve rapid and complete elimination of migraine pain and their most bothersome symptom of sensitivity to light, sensitivity to sound, or nausea," said Dr. Cori Millen, medical director of Summit Headache and Neurologic Institute. "Recent guidance issued by both the FDA and the American Headache Society raised the clinical bar by recommending migraine clinical trial efficacy demonstrates pain freedom and freedom from most bothersome symptoms, rather than just pain relief. REYVOW is the first FDA-approved acute medicine for migraine to meet this new standard."
In the International Burden of Migraine Study, a web-based survey of 9715 adults with migraine, 79% of patients reported experiencing severe pain during a migraine attack. Triptans are recommended as an acute therapy for migraine for appropriate patients by the American Headache Society. However, when speaking to patients with migraine, 79% said they would be willing to try another acute treatment.
"People with migraine experience attacks that can be severely burdensome, intensely painful and debilitating," said Michael Cobas Meyer, MD, vice president, global medical affairs, Lilly Bio-Medicines. "With a single dose, REYVOW offers the chance for quick and complete elimination of moderate to severe migraine pain in just two hours. When asking people with migraine, they prioritize fast and complete elimination of pain from acute treatments. We feel fortunate we can now provide patients with a treatment option that helps achieve that outcome."
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The efficacy of REYVOW for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled, single-attack trials (SAMURAI and SPARTAN) of 4439 patients who took 50-mg, 100-mg, or 200-mg doses of REYVOW or placebo. Pain freedom, defined as a reduction of moderate or severe headache pain to no pain at two hours, and freedom from MBS, defined as the absence of the self-identified MBS (photophobia, phonophobia, or nausea) at two hours, were the primary and secondary efficacy endpoints. Across two clinical studies and three doses, 28-39% of patients achieved complete elimination of migraine pain at two hours with REYVOW compared to 15% and 21% with placebo. Across two clinical studies and three doses, 41-49% of patients achieved freedom from their MBS at two hours with REYVOW versus 30% and 33% with placebo.
Treatment emergent adverse events were generally mild to moderate and the most frequent included dizziness, fatigue, paresthesia (tingling or numbing sensation on the skin), sedation (sleepiness or drowsiness), nausea and/or vomiting, and muscle weakness. With new FDA guidelines in 2018 and to gain understanding about potentially centrally acting medicines' impact on patients' ability to drive, Lilly conducted two driving studies to assess REYVOW. Study results showed that REYVOW may cause significant driving impairment, as all doses of REYVOW impacted study participants' ability to drive. Additionally, more sleepiness was reported at eight hours compared to placebo. Other warnings and precautions include CNS depression, serotonin syndrome and medication overuse headache.
REYVOW is a non-opioid/non-narcotic, Schedule V medication that has low abuse potential and no evidence of physical dependence. The Drug Enforcement Administration (DEA) schedules controlled substance drugs from I to V, I being the highest potential for abuse and/or dependence and V being the lowest potential for abuse and/or dependence.