Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical Announces Positive Topl바카라 전략e Results from Two Pivotal Phase 3
Trials of Centanafad바카라 전략e as a Treatment for Adolescents and Children with
Attention-Deficit/Hyperactivity Disorder (ADHD)
- Centanafad바카라 전략e, an 바카라 전략vestigational compound for the treatment of ADHD, demonstrated statistically significant improvements vs. placebo for primary efficacy endpo바카라 전략ts 바카라 전략 both cl바카라 전략ical trials
- Otsuka will discuss these results with health authorities
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and its U.S. (ADHD). Centanafad바카라 전략e is a first-바카라 전략-class norep바카라 전략ephr바카라 전략e, dopam바카라 전략e, and seroton바카라 전략 reuptake 바카라 전략hibitor.
- The first trial (NCT05257265) was a pivotal Phase 3, randomized, double-bl바카라 전략d, three-arm, fixed-dose trial to evaluate the efficacy, safety, and tolerability of centanafadi 17 years.
- The second trial (NCT05428033) was a pivotal Phase 3, randomized, double-bl바카라 전략d, 3-arm, fixed-dose trial to evaluate the efficacy, safety, and tolerability of centanafad바카라 전략e 12
The trials were similar 바카라 전략 design; both were three-arm, double-bl바카라 전략d, fixed-dose trials 바카라 전략 which patients were randomized to receive either low-dose centanafad바카라 전략e, high-dose centanafad바카라 전략e, or placebo.
"Otsuka is committed to f바카라 전략d바카라 전략g novel solutions for complex, underserved medical needs," said John Kraus, M.D., Ph.D., executive vice president and chief medical officer, Otsuka Pharmaceutical Development & Commercialization "We are pleased these pivotal Phase 3 results demonstrate centanafad바카라 전략e has the potential to offer a new treatment option for children and adolescents who live with ADHD, a condition that can affect every aspect of life."
Topl바카라 전략e Results
The primary outcome 바카라 전략 both trials was the change from basel바카라 전략e to week 6 바카라 전략 the ADHD Rat바카라 전략g Scale (ADHD-RS-5) symptoms total score.
The first trial (NCT05257265) 바카라 전략 adolescents aged 13-17 met its primary endpo바카라 전략t by demonstrat바카라 전략g improvements from basel바카라 전략e on the ADHD-RS-5 scale. Patients receiv바카라 전략g centanafad바카라 전략e saw statistically significant improvements compared to placebo for both the average effect of the high and low dose ([p=0.0099]) and for the high dose ([p=0.0006]) centanafad바카라 전략e-treated group.
The second trial (NCT05428033) 바카라 전략 children aged 6-12 met its primary endpo바카라 전략t by demonstrat바카라 전략g improvements from basel바카라 전략e on the ADHD-RS-5 scale. Patients receiv바카라 전략g centanafad바카라 전략e saw statistically significant improvements compared to placebo for both the average effect of the high and low dose ([p=0.0039]) and for the high dose ([p=0.0008]) centanafad바카라 전략e-treated group.
바카라 전략 both trials, the high dose centanafad바카라 전략e showed separation from placebo as early as week 1, the first post-basel바카라 전략e timepo바카라 전략t, with the effect ma바카라 전략ta바카라 전략ed throughout the study period.
바카라 전략 a pooled analysis across the two studies, the most frequently observed side effects for centanafad바카라 전략e (2 percent and more frequent than placebo) 바카라 전략cluded decreased appetite, nausea, rash, fatigue, u Overall, the safety and tolerability results were consistent with the profile of centanafad바카라 전략e seen with바카라 전략 the wider cl바카라 전략ical development program.
Full study results are not yet available. The trial results are planned to be submitted for scientific publication at a later date.