Shire Gets FDA Approval For INTUNIV

Shire has received FDA approval for INTUNIV (guanfacine) extended release tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

Mike Cola, president of Shire Specialty Pharmaceuticals, said: Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option. This is a complex disorder in which patients may present with multiple symptoms and behaviors that can be disruptive. INTUNIV expands the Shire ADHD portfolio with a nonscheduled medication, allowing clinicians to optimize their overall approach toward managing ADHD and may help provide symptom control for children and teens with ADHD who often have difficulty responding appropriately to everyday situations and challenges.

Once-daily INTUNIV is expected to be available in US pharmacies from November and will come in four dosage strengths (1mg, 2mg, 3mg, and 4mg). INTUNIV will be marketed in the US by the existing Shire ADHD sales team of nearly 600 representatives.

The efficacy of INTUNIV in the treatment of ADHD was established in two, similarly designed, placebo-controlled clinical trials in children and adolescents aged 6 to 17 years, who met Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for ADHD.