FLORHAM PARK, N.J., Jan. 10, 2011 /PRNewswire/ — Shionogi Inc.,
the U.S.-based group company of Shionogi & Co., Ltd., today
announced a true milestone as it marks the first commercial
availability for the non-central nervous system stimulant
medication KAPVAY™, an extended-release oral formulation of
clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in
children and adolescents. KAPVAY™ is the first and only
FDA-approved ADHD treatment indicated for use as add-on therapy to
stimulant medication, in addition to use as monotherapy.
“Shionogi is extremely proud to bring KAPVAY™ to market in
the U.S.,” said Donald C. Manning, MD, PhD, Chief Medical Officer
of Shionogi Inc. “The extended-release version of clonidine
hydrochloride found in KAPVAY™ offers an exciting new
treatment option for children and adolescents with ADHD who are not
experiencing adequate symptom relief from stimulants alone.”
ADHD affects more than 4.5 million children in the U.S., with at
least 7 percent of U.S. school-aged children believed to suffer
from the condition. Symptoms include difficulty in
maintaining attention and focus and in controlling behavior, as
well as hyperactivity/over-activity. While stimulant
medications remain a first line treatment for ADHD, up to 30
percent of ADHD patients do not achieve an optimal response to
stimulant monotherapy.
KAPVAY™’s recent FDA approval was based on two Phase III
studies, which demonstrated significant efficacy at Week 5 in
children and adolescents (6-17 years) with ADHD treated with
KAPVAY™. Signs and symptoms of ADHD were evaluated
using the investigator administered and scored ADHD Rating
Scale-IV-Parent Version (ADHDRS-IV) total score, including
hyperactive/impulsivity and inattentive subscales.
Treatment-emergent adverse events, such as somnolence and
fatigue, were mostly mild to moderate. Thirteen percent (13%) of
patients
‘/>”/>
