New migraine drug! AbbVie oral CGRP receptor antagonist atogepant prevention migraine Phase III clinical success!

!--webeditor: "page title" -- AbeVie recently announced that the Phase III ADVANCE trial for evaluating the treatment of migraines has reached its main end.
data show edified that all doses (10 mg, 30 mg, 60 mg) atogepant significantly reduced the average number of migraine days per month from baseline levels significantly compared to placebos during 12 weeks of treatment.
in addition, two high doses (30 mg, 60 mg) showed a statistically significant improvement in all six secondary endpoints.
based on these results, as well as the results of previous positive phase 2/3 tests, AbbVie plans to file regulatory filings in the United States and other countries.
full data results will be published and/or published in a peer-reviewed journal at the upcoming medical conference.
atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist that is specifically developed for preventive treatment of migraines.
CGRP and its receptors are expressed in the nervous system regions associated with the pathophysiology of migraines.
studies showed that CGRP levels increased during migraine attacks, and selective CGRP receptor antagonists had clinical effects on migraines.
in the migraine sector, AbbVie is selling BOTOX (®, Botox A, onabotulinum A) and Ubreepantoxint.
, BOTOX is the first FDA-approved preventive drug for chronic migraines in adults, and Ubrelvy is the first FDA-approved oral CGRP receptor antagonist (gepant) for acute treatment of adult migraines (with or without warning). "Migraine attacks can debilitate people, but migraines are a treatable disease," said Thomas J. Hudson, Ph.D., senior vice president and chief scientific officer at
AbbVie.
based on the results of these trials, our goal is to provide a safe and effective preventive treatment that provides patients and healthcare providers with a simple, once-a-day oral drug that works by blocking CGRP receptors and preventing migraines.
"atogepant Chemical Structure (Photo: Genome.jp) on Key PHASE III ADVANCE Trial: This is a multicenter, randomized, double-blind, placebo-controlled, parallel group III trial designed to assess the effectiveness, safety and tolerance of oral atogepant to prevent migraines. A total of 910 patients in
were randomly divided into 4 treatment groups, three doses (10 mg, 30 mg, 60 mg) atogepant, placebo, orally once daily.
efficacy analysis was based on improved intentional therapy (mITT) in 873 patients.
the main endpoint was a change in the average number of migraine days per month compared to the baseline during 12 weeks of treatment.
data showed that all atogepant dose groups reached the primary endpoint and that the average number of migraine days per month was statistically significantly reduced compared to placebos.
10mg/30mg/60mg atogepant group decreased by 3.69/3.86/4.2 days, and placebo group by 2.48 days (all dose groups were compared to the placebo group, p.0001).
a key secondary endpoint measured the proportion of patients who had at least 50 percent fewer migraine days per month during 12 weeks of treatment.
data showed that the 10mg/30mg/60mg atogepant group had a reduction of at least 50% in 55.6%/58.7%/60.8% of patients, and 29.0% of patients in the placebo group (all dose groups compared to the placebo group, p.0001). Other secondary endpoints measured during the 12-week treatment
included: average number of headache days per month, average number of days of acute drug use per month, changes in the average daily activity performance in Migraine Diary Activity Impairment (AIM-D) and changes in the field score of physical injury from baseline, and changes in the role limitation field score of the Migraine-specific Quality of Life Questionnaire (MSQ) at the 12th week.
trials showed a statistically significant improvement in the 30 mg and 60 mg dose groups at all secondary endpoints, while 4 of the 10 mg dose groups showed statistically significant improvements in 4 of the 6 secondary endpoints.
security, no new security risks were observed compared to the security observed in previous experiments assessed by atogepant.
patients in the 10 mg dose group had 0.9 patients, 0.9% of patients in the placebo group had severe adverse events, and patients in the 30 mg dose group and 60 mg dose group had no serious adverse events.
in at least one atogepant treatment group, the most common adverse events with frequencies of 5% and higher than placebo were constipation (6.9-7.7% in all dose groups, 0.5% in the placebo group), nausea (4.4-6.1% in all dose groups, 1.8% in the placebo group) and upper respiratory tract infections (3.9-5.7% in all dose groups and 4.5% in the placebo group).
most cases of constipation, nausea and upper-suction infections have mild or moderate severity and do not cause discontinuation.
found no liver safety in the trial.
Phase 2/3 CGP-MD-01 study: This study assessed the efficacy, safety, and tolerance of oral atogepant.
data showed that all treatment groups in atogepant reached the primary endpoint, with a significant reduction in the average number of migraine days per month compared to the baseline compared to placebo spent in 12 weeks of treatment (10mg QD vs Placebo, p-0.0236; 30mg QD vs placebo) p.0390; 60mg QD vs placebo, p?0.0390; 30mg BID vs placebo, p-0.0034; 60mg BID vs placebo, p-0.0031).
results were published in June 2018.
(!--/ewebeditor::!--webeditor: "page title""--Siendo AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention !--/ewebeditor."