Atogepant- new solution for migraines

USA: In a new article published in the Journal of American Medical Association, atogepant was shown to be effective and well-tolerated for the preventive treatment of migraine. This was evident by a significant reduction in the average monthly migraine day (MMD) at each response threshold.

Patients with migraine, especially those in primary care, require effective and tolerable migraine-specific oral prophylaxis. Therefore, this study was conducted by Richard B. Spencer and his team, using a four-level mean MMD response to an oral, small molecule, calcitonin gene-related peptide receptor antagonist, Atogepant, and evaluated the effectiveness of-Investigate rates.

A secondary analysis of this Phase 3 placebo-controlled, double-blind, randomized clinical trial found migraine prevention in adults aged 4 to 14 years from December 14, 2018, to June 19, 2020. We evaluated the efficacy and safety of Atogepant for clinical trials. The number of days of migraine per month is 128 locations in the United States. Patients should take Atogepant10 mg (n = 222), Atogepant 30 mg (n = 230), Atogepant 60 mg (n = 235), or placebo (n = 223) once daily, 1: 1: 1: 1. It was administered 12 times at the ratio of. several weeks. In these analyses, participants achieved an average MMD reduction of 50% or greater (secondary endpoint of alpha control) and 25% or greater, 75% or greater, and 100% (additional pre-specified endpoint). The treatment response rate defined was evaluated. On average, MMD under treatment reached a 12-week blinded treatment period.

The key findings of this study were as follows:

1. Of the 902 participants, 873 joined the modified ITT population. As for secondary endpoints, 119 of 214 (55.6%) treated with Atogepant 10 mg and 131 of 223 (58.7%) treated withAtogepant 30 mg experienced a 12-week reduction.

2. Did-Average MMD achieved over 50%. 135 of 222 subjects (60.8%) were treated with Atogepant 60 mg and 62 of 214 (29.0%) received a placebo.

3. The number of participants who reported a 25% or greater reduction in mean 12-week MMD was 157/214 (73.4%) with 10 mg of Atogepant, 172/223 (77.1%) with 30 mg Atogepant, and 180 of 222 (2). It was 81.1%).

4. In the case of Atogepant 60 mg, 126 (58.9%) of 214 in the case of placebo. The number of participants who reported a 75% or greater reduction in mean MMD was 65/214 (30.4%) with Atogepant 10 mg, 66/223 (29.6%), and 84/222 (37.8%) with Atogepant 30 mg.

5. With 60 mg of Atogepant compared to 23/214 (10.7%) of placebo. The number of participants who reported a 100% reduction in mean MMD was 17/214 (7.9%) with Atogepant 10 mg, 11/223 (4.9%) with Atogepant 30 mg, and 17/222 (7.7%) with Atogepant 60 Mg Atogepant compared to 2/214 (0.9%) of placebo.

"Atogepant appears to be effective and well-tolerated for the preventive treatment of migraine as measured by 4 levels of the clinically meaningful end point of responder rates," the authors wrote.

They concluded, "higher doses of atogepant appear to produce the maximum response rate, which may help physicians customize the starting dose.

Reference:

Lipton, R. B., Pozo-Rosich, P., Blumenfeld, A. M., Dodick, D. W., McAllister, P., Li, Y., Lu, K., Dabruzzo, B., Miceli, R., Severt, L., Finnegan, M., & Trugman, J. M. (2022). Rates of Response to Atogepant for Migraine Prophylaxis Among Adults. In JAMA Network Open (Vol. 5, Issue 6, p. e2215499). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2022.15499