The U.S. Food and Drug Administration (FDA) has given the green light to the nonstimulant medication Kapvay (clonidine hydrochloride) as the first drug used to treat attention deficit hyperactivity disorder (ADHD) that can be used as an add-on therapy to stimulant medication.
Kapvay has been approved as an extended-release tablet and extended-release oral formula for treatment in children ages 6 to 17 years.
It’s currently the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD and can be used as a monotherapy as well.
Manufactured by Shionogi, Kapvay is a centrally acting alpha2-adrenergic receptor agonist. These receptors are believed to involve the prefrontal cortex (PFC) of the brain.
Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.
“The FDA approval of Kapvay represents an exciting milestone in the field of ADHD,” said Donald C. Manning, MD, PhD, chief medical officer of Shionogi.
“The extended-release formulation of Kapvay minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery.”
The FDA approval followed two phase III trials — one directed for use as a stand-alone treatment and the other as an add-on to therapy with a stimulant.
The monotherapy trial was a randomized study that encompassed 236 patients with ADHD or a combined inattentive/hyperactive subtype over an eight-week period. Two groups of patients received either .4 mg dosage or .2 mg dosage per day of clonidine. The third group received a placebo.
The second eight-week study assessed 198 patients who had been treated with a psychostimulant for four weeks and have achieved poor response. One group received .4 mg per day of clonidine alongside a psychostimulant while the other group received only the psychostimulant.
ADHD symptom scores showed significant improvement in each clonidine group over placebo. Notably, significant improvement was seen in the clonidine and psychostimulant group over psychostimulant-alone group at five weeks of treatment.
Rakesh Jain, MD, MPR, director of psychiatric drug research for Texas-based R/D Clinical Research and an investigator in the trials added that “ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms. Kapvay, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone.”
The most common and drug-related adverse reactions included somnolence, fatigue, upper respiratory tract infection, irritability, throat pain, insomnia, nightmares, emotional disorder, constipation, nasal congestion, increased body temperature, dry mouth and ear pain.
Kapvay has not been studied in children with ADHD who are less than 6 years old, and it should not be used in patients with known hypersensitivity to clonidine.
ADHD is a mental disorder that occurs in childhood and may continue into adolescence and adulthood. The disorder affects more than 4.5 million children ages three to 17 in the U.S. alone. Approximately three to seven percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/overactivity.
Source: Shionogi, Inc.