20 years of great innovation! Lilly 5-HT1F Agonist Reyvow New Phase III Study: Take the drug for 1 hour and the pain disappears for 48 hours!

!--,2020 // -- Eli Lilly recently presented the results of a new Phase III clinical study on the evaluation of the oral drug Reyvow (lasmitan) C-V tablet for the treatment of migraine attacks in adult patients at the PAINWeek®2020 Real-Time Virtual Conference.
the study, which was recently completed, showed that patients taking Reyvow 100mg and 200mg were 3.8 times more likely to achieve pain relief two hours after taking it and 4.6 times more likely to achieve pain relief (common primary endpoint).
addition, Reyvow showed better than a placebo on all 18 gated endpoints, including medication for the first migraine attack 1 hour (200 mg dose) after taking pain relief, 1 hour and Percentage of patients with 2 hours (2 doses) pain relief, 24 hours (2 doses) and 48 hours (200 mg) of continuous pain loss, and no disability (disability, disability) at 2 hours (2 doses).
Reyvow is an oral prescription drug approved by the FDA in October 2019 for acute treatment of migraines in adult companions or without precursor symptoms.
Reyvow represents the first new class of acute migraine therapy drugs approved by the FDA in more than 20 years.
the drug is the FDA-approved first 5-HT1F-subject agonist that can act on both the central and exosome nerves, unlike other acute migraine therapy drugs currently on the market.
important to note that Reyvow is not suitable for preventive treatment of migraines, the dose size is 50 mg, 100 mg, 200 mg, flexible choice as needed.
in clinical studies, Reyvow quickly and completely eliminated migraine pain and its most annoying symptoms (nausea, light sensitivity, or sound sensitivity) in just 2 hours.
new guidance from the FDA and the American Headache Association raises clinical standards, suggesting that migraine drug clinical trials need to prove the effectiveness of eliminating pain and eliminating the most annoying symptoms, not just pain relief.
Reyvow is the first FDA-approved acute migraine treatment to meet this new standard.
CENTURION study evaluated The effectiveness and safety of Reyvow in acute treatment of migraines (with or without precursor symptoms) in adults, including consistency of treatment response in 4 seizures.
the study, 1,471 migraine patients were randomly grouped and received At least one Reyvow 200mg (n=486), 100mg (n=485), and control therapy (placebo for partial but not all seizures, n=500).
study, patients treated migraine seizures with pain for at least moderate pain and within 4 hours of the onset of pain.
common main therapeutic endpoints included the disappearance of pain 2 hours after the first seizure, and 2 hours after taking the drug in 2 of the 3 seizures.
end points include 1 hour of pain disappearance, 24 hours and 48 hours of continuous pain disappearance, 1 hour and 2 hours of pain relief.
patients entered the results into an electronic journal 30 minutes, 60 minutes, and 2, 4, 6, 24 and 48 hours after giving the drug.
treatment comparisons in the study were pre-specified, with 18 endpoints gated, meaning they were set before the end of the study, and each comparison was reviewed separately in a specific order to verify the accuracy of the results.
1, Reyvow is superior to a placebo in pain disappearance.
(Pain loss means pain reduced to pain-free during baseline examination) - 2 hours and 1 hour pain loss results: Data show that the Reyvow 200mg group is 4.6 times (29.3% vs 8.4% of the placebo group) in the 2 hours (common primary endpoint) of pain loss; 4.6;p<0.001; Treatment gain of approximately 21%), Reyvow 100mg group is 3.8 times that of placebo group (25.8% vs 8.4% ;p slt;0.001; Treatment gain of approximately 17%).
these treatments reflected differences in the percentage of patients in the Reyvow group and the placebo group who were pain-free for 2 hours.
200mg group was 7 times more likely to achieve pain disappearance in 1 hour (12.7% vs 2.0% ;p-lt;0.001) and 3 times more likely to be in the placebo group (6.0% vs 2.0%).
- 24-hour and 48-hour pain disappearance results: Reyvow 200mg was 4.7 times more likely to achieve continuous pain disappearance in 24 hours (17.3% vs 4.3) The reyvow 100mg group was 3.5 times higher than the placebo group (13.6% vs 4.3%, p.lt;0.001).
48-hour risk of persistent pain disappearance, the Reyvow 200mg group was 4.1 times higher than the placebo group (15.4% vs. 4.3%, p.lt;0.001), and the Reyvow 100mg group was 2.2 times (9.3% vs 4.3% in the placebo group).
Uwe Reuter, M.D., Professor of Neurology, M.D., and M.D., Charlest University Hospital in Berlin, Germany, said: "Migraine attacks affect patients in different ways, so it is important that patients have options to help achieve their individual treatment goals.
encouraged by this study, in which we saw that Reyvow helps patients achieve pain disappear, as early as 60 minutes after taking it and lasts up to 48 hours.
"2, Reyvow was superior to a placebo in patients with pain relief, indeptutation (disability), and a history of Quptan therapy.
(Pain relief refers to pain levels reduced to mild or complete disappearance) (1) 2 hours and 1 hour pain relief results: Nearly two-thirds of patients treated with Reyvow had pain relief at 2 hours, 65.2% in reyvow 200mg and 65.4% in the 100mg group, and 41.3% in the placebo group (both p.lt;0.001).
in 1 hour, almost half of the patients treated with Reyvow achieved pain relief, 47.2% in the Reyvow 20mg group, 48.7% in the 100mg group, and 29.3% in the placebo group (average p.lt;0.001).
!--/ewebeditor:page--!--ewebeditor:page title"--(2)2 hours of disability (disability) results, 2 hours results from the group of patients with a history of Quptan therapy: When asked if migraines affect daily activity 2 hours after treatment Nearly one in five patients treated with Reyvow reported that this was no longer the case (19.8 per cent in the 200mg group and 18.6 per cent in the 100mg group), about twice as much as in the placebo group (9.5 per cent; average p-lt;0.001).
For those who had tried Quptan to treat migraine attacks that were ineffective, intolerable, or had contraindications, patients who took Reyvow lost pain within 2 hours (24.0 percent in the 100mg group and 25.6 percent in the 200 mg group) nearly three times as many patients who took a placebo (8.8 percent).
Dr Timothy R. Smith, investigator and president and CEO of StudyMetrix Research, said: "In this study, patients taking Reyvow achieved better results in pain disappearance, pain relief, disability-free and other important treatment outcomes after the first migraine attack than those who took a placebo.
given that so many patients need help treating their weak migraine attacks, this analysis is exciting because migraines often interfere with everyday life.
"3, safety findings observed in THECENTURION studies are usually consistent with previous Reyvow clinical trials.
during the study period, the rates of adverse events (TEAE) occurred during severe treatment in each treatment group were similar: Reyvow 200mg group (n=2 (0.4%)), 100mg group (n=1 (0.2%)), placebo group (n=2 (0.4%).
Reyvow's most common TAAE after treatment with the first seizure (in any dose group of 2 percent in the first episode) included dizziness, sensory abnormalities (tingling), fatigue, nausea, dizziness (feelings of rotation or movement), drowsiness (feeling tired), muscle weakness, weakness (abnormal weakness) feeling abnormal.
"We are excited about Reyvow's insights from the well-designed CENTURION study, including the remarkable effects of pain disappearance within 2 hours, and look forward to sharing consistent results at the 18th International Symposium of Migraine Trust (MTIS 2020) next month, October 3-9," said Patrik Jonsson, Senior Vice President and President of Lilly Biopharmaceuticals.
important for healthcare providers and their patients in making important treatment decisions for migraine attacks.
" migraine is a common chronic neurovascular disease characterized by recurrent severe headaches, mostly on the side.
, there is no cure for migraines.
The World Health Organization (WHO) has listed migraines as one of the 10 most disabling diseases.
Reyvow's active pharmaceutical ingredient is lasmiditan, an oral, central nervous system permeability, selective, 5-serotonin 1F (5-HT1F) agonist that differs structurally and institutionally from the migraine drug currently approved and does not have vasosal contraction activity.
note that lasmiditan is the first and only drug molecule approved for acute treatment of migraines in adults.
this approval represents the first major innovation in acute migraine treatment in more than 20 years.
, like other drugs with central nervous system (CNS) activity, the FDA requires a study of Reyvow's abuse potential.
is the potential for abuse of a particular drug product or substance with CNS activity.
In consistent with FDA guidelines, Lilly conducted an assessment of human abuse potential, and as part of the assessment, Reyvow's therapeutic dose was associated with fewer drug preferences than alprazolam, but more than placebos.
() Original source: REYVOW™ C-V Marched Pain From Freedom Migraine Attacks At 60 Minutes and Up to 48 Hours in New Phase 3 !--/ewebeditor:page--