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 receiving KAPVAY™ discontinued from the pediatric monotherapy study due to adverse reactions. In the pediatric adjunctive treatment to stimulants study, one patient out of 102 discontinued from KAPVAY™.
"There is a portion of children and adolescents who suffer from symptoms of ADHD who are not responding optimally to current therapies," said Rakesh Jain, MD, MPH, Assistant Clinical Professor, Department of Psychiatry, Texas Tech University School of Medicine – Permian Basin, Midland, Texas and Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and one of the investigators in the clinical trials. "The availability of an extended-release formulation of clonidine hydrochloride is an important addition to the current ADHD treatment landscape."