Date: 12-Jun-2020

Otsuka Announces Positive Top-line Results From Two Phase 3 Studies Of Centanafadine For The Treatment Of Attention-deficit Hyperactivity Disorder (AD

TOKYO & PRINCETON, N.J.--(BUSINESS WIRE)-- Otsuka Pharmaceutical Co., Ltd. and Otsuka Pharmaceutical Development & Commercialization, Inc., a U.S. subsidiary, announce positive top-line results from two, six-week, phase 3 clinical trials that evaluated the efficacy, safety and tolerability of oral centanafadine, a novel investigational compound for the treatment of adult patients with attention-deficit hyperactivity disorder (ADHD). The company also plans to investigate the effects of centanafadine in pediatric patients with ADHD, as well as to discuss next steps with the U.S. Food and Drug Administration.

In both trials, 200 mg and 400 mg total, daily oral doses of centanafadine demonstrated statistically significant improvement vs. placebo on the primary efficacy endpoint, change from baseline to Day 42 on the adult ADHD investigator symptom rating scale (AISRS) total score (p < 0.05 in the first study and p < 0.01 in the second study). AISRS is an interview-based evaluation of ADHD symptoms in adult patients, with hyperactive/impulsive and inattention subscales.2

In both trials, statistically significant improvements versus placebo were also observed in the key secondary efficacy outcome, CGI-S (Clinical Global Impression – Severity scale) change from baseline to Day 42 (p < 0.05).

In a pooled-analysis across the two studies, the most frequently observed side effects for centanafadine (>5 percent and more frequent than placebo) included decreased appetite, headache, nausea, dry mouth, upper respiratory tract infection and diarrhea; no side effect was observed in greater than 7 percent of patients.

About Centanafadine and the Phase 3 Program

Centanafadine is a serotonin-norepinephrine-dopamine, triple-reuptake inhibitor. Approximately, 900 adult patients from age 18 to 55 years old, and diagnosed with ADHD, were randomized in the two phase 3 studies. The studies were randomized, double-blind, multicenter, and placebo-controlled with parallel groups. Patients were randomized 1:1:1 to receive either centanafadine doses of 100 or 200 mg, twice daily (total daily dose of 200 mg or 400 mg, respectively), or placebo twice daily. A long-term safety and tolerability study of centanafadine in a 400 mg total daily dose is ongoing, with top-line results expected in 2021.

About ADHD1

According to the Attention Deficit Disorder Association, an estimated 5 percent (11 million) of adults in the U.S. have ADHD, a neuro-behavioral condition that impacts the regulation of a particular set of brain functions and related behaviors. These brain operations include important functions such as attention, concentration, memory, motivation and effort, learning from mistakes, impulsivity, hyperactivity, organization, and social skills. ADHD has no known cure and the majority of people do not outgrow it. Approximately two-thirds or more of children with ADHD continue to have symptoms and challenges in adulthood.

For additional information on ADHD, please visit the National Institute of Mental Health website.

About Otsuka Pharmaceutical

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy, "Otsuka–people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is dedicated to clinical development of promising drug candidates and services in mental health, oncology, cardio-renal, nephrology and digital health. Other activities include strategic planning for drug approval, marketing, and lifecycle management to maximize a product's full potential.

OPDC is an indirect subsidiary of Otsuka Pharmaceutical Company, Ltd., which is part of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13 billion in 2019.