Shionogi & Co., Ltd. (hereafter ‘Shionogi’) today announced that Shionogi applied for approval to manufacture and sell the therapeutic agent for adult indication of attention deficit hyperactivity disorder (ADHD), INTUNIV Tablets 1mg/3mg (generic name: guanfacine hydrochloride).
Shionogi & Shire conducted the clinical studies of INTUNIV in adult ADHD patients (18 years old and over) in Japan first in the world. INTUNIV demonstrated a statistically significant improvement compared with placebo in the primary endpoint of ADHD evaluation scale. INTUNIV also demonstrated statistically significant superior efficacy compared with placebo in the clinically important secondary endpoint of the clinical global impression improvement scale (CGI-I). Additionally, INTUNIV demonstrated favorable safety and efficacy profile in long-term treatment for 1 year at longest.
INTUNIV is a ‘selective 2A adrenergic receptor agonist’, firstly approved as a drug for ADHD with this mechanism of action, and INTUNIV is a non-central nervous system stimulant that is to be administered once daily and has been approved as a drug for ADHD in pediatric patients (6 to 17 years old) in 36 countries including Japan. In Japan, Shionogi launched INTUNIV for indication of ADHD in pediatric patients on May 2017. Shionogi will further contribute to treatment of ADHD through providing INTUNIV as a new treatment option for adult ADHD patients.
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