Shire has announced that its partner in Japan, Shionogi & Co., Ltd., has received the approval of the Japanese Ministry of Health, Labor and Welfare (MHLW) to manufacture and market Intuniv. Intuniv is a new, once-daily non-stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD), a common psychiatric disorder in children and adolescents.
ADHD causes inattention, hyperactivity or impulsivity, or a combination of these symptoms, and can have substantial impact on all major areas of life, including: schooling, work and employment, behaviour, social functioning, self-esteem and health.
Intuniv is a selective alpha-2A adrenergic receptor agonist. With a unique mechanism of action, Intuniv represents an additional treatment option in the management of ADHD.
"Shire is committed to ensuring that every person with ADHD is able to benefit from a treatment most suited to their needs," said Philip J Vickers, PhD, Global Head of Shire Research and Development. "The approval of Intuniv marks a significant advance in the treatment of ADHD in children and adolescents in Japan, who may benefit from a new treatment option."
As part of the partnership, a phase 3 placebo-controlled clinical study and long-term extension study evaluating the efficacy and safety of Intuniv in 254 patients was conducted in Japan. In the trial, Intuniv administered once daily, showed significant improvements over placebo, as measured by ADHD-RS-IV total score, in all core symptoms of ADHD: hyperactivity/impulsivity, and inattention. The most common adverse events were somnolence in 146 patients (57.5%), decreased blood pressure in 39 patients (15.4%), and headache in 31 patients (12.2%).
ADHD is a complex condition and approaches to treatment typically include educational methods, psychotherapy and medication. When required, either stimulants or non-stimulants are indicated as part of a comprehensive treatment programme for ADHD. Children and adolescents have a wide spectrum of individual needs as patients, so it is important that a range of treatment options are available. Non-stimulant medications are an important alternative to stimulants for some ADHD patients.