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Shire and Shionogi Announce Positive Topline Results for INTUNIV® Evaluated in Phase 3 Clinical Trial in Adults with ADHD

(September 20, 2017)

Shire and Shionogi Announce Positive Topline Results for INTUNIV® (guanfacine hydrochloride prolonged release) Evaluated in Phase 3 Clinical Trial
in Adults with ADHD

  • Topline results revealed the study met its primary endpoint for INTUNIV® (4 to 6 mg) administered once daily, indicating superiority over placebo in ADHD symptom improvement
  • Results also showed improvement over placebo in patients' global functioning

Zug, Switzerland  - September 20, 2017 - Shire plc (LSE: SHP, NASDAQ: SHPG) and its partner in Japan, Shionogi & Co., Ltd, announced that a Phase 3 study evaluating INTUNIV® (guanfacine hydrochloride prolonged release) in adult patients with attention deficit hyperactivity disorder (ADHD) in Japan has positive topline results, and the study met the primary endpoint. This is the first clinical trial evaluating INTUNIV in adult patients (18 years old and over) with ADHD.

"The positive topline results of this Phase 3 study provide us with important data and insights regarding the clinical profile of INTUNIV in adult patients with ADHD," said Brigitte Robertson, VP and Head of Global Clinical Development, Neuropsychiatry, Shire. "We are evaluating the full data set, and excited to advance the development of INTUNIV as a non-stimulant treatment option for adults with ADHD in Japan, building on the established efficacy and safety data for ADHD in child and adolescent patients."

INTUNIV, a non-stimulant and selective alpha-2A adrenergic receptor agonist1 is currently approved as a treatment for child and adolescent patients (6 to 17 years old) in Japan. INTUNIV is being evaluated in Japan as a potential treatment option for ADHD in adults, a therapeutic area with significant need. Japan is the third largest ADHD market, growing at more than 20% annually.

ADHD causes inattention, hyperactivity or impulsivity, or a combination of these symptoms,2,3 and can have substantial impact on all major areas of life, including: schooling, work and employment, behaviour, and social functioning.4-7

This Phase 3 trial was a 12-week, randomized, double-blind, multi-center, parallel-group, placebo-controlled study in 201 adult patients (18 years old and over) with ADHD. The primary efficacy analysis demonstrated that INTUNIV  (4 to 6mg), administered as a once-daily dose, was superior to placebo with respect to the change from baseline on a clinically administered ADHD rating scale (ADHD-RS-IV with adults prompts) total score. INTUNIV also demonstrated nominal significance over placebo at the end of treatment on the clinically important secondary efficacy analysis of the clinical global impression improvement scale (CGI-I), suggesting more patients achieved a marked clinical improvement in global functioning.

The CGI-I is a standardized assessment tool that allows clinicians to rate the severity of an illness, change over time and response to treatment.  

Treatment-emergent adverse events in the study were generally mild to moderate in severity and similar to those observed in previous INTUNIV studies with no new or unexpected safety findings. Treatment emergent adverse events reported at more than or equal to 10% for INTUNIV were somnolence, dry mouth, blood pressure decrease, nasopharyngitis, dizziness postural and constipation.

Shire Japan and Shionogi will evaluate the full data, and will communicate plans for publication or presentation of the data, as well as potential milestones for the continued development of INTUNIV in adults with ADHD.

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