FDA approvals: A new ADHD treatment for six-year-olds

September 4, 2009

The FDA has approved a new type of drug, an alpha-2A adrenergic receptor agonist, to treat ADHD in children as young as six.

The Food and Drug Administration (FDA) has approved a new type of drug, an alpha-2A adrenergic receptor agonist, to treat attention-deficit hyperactivity disorder (ADHD) in children as young as six.

The new ADHD drug, gunafacine (Intuniv), is from Shire Pharmaceuticals. The approval is for children ages 6 to 17 years of age. It will come in four dosage strengths, 1, 2, 3, and 4 mg, and is a nonscheduled medication. Its common adverse events include somnolence, headache, fatigue, upper abdominal pain, and sedation.

FDA also approved two treatments for less common maladies. For cytomegalovirus in pediatric kidney and heart transplant recipients, it approved the antiviral valganciclovir hydrochloride (Valcyte) from Roche. And for children ages 1 to 12 with cystic fibrosis, it approved pancrelipase (Zenpop), a pancreatic enzyme product made by Eurand NV.