(June 21, 2007) -- Basingstoke, the UK - based drug manufacturer Shire Plc announced on Friday morning that it received an approvable letter from FDA for Intuniv extended release tablets or guanfacine, intended for Attention Deficit/Hyperactivity Disorder or ADHD. The company said it would be working closely with FDA to address the questions raised by the regulatory agency.

Intuniv is a non-stimulant selective alpha-2A receptor agonist. Around 4.4 million children in US aged 4 to 17 years have ADHD and is one of the most common psychiatric disorders in children and adolescents. The disorder is also estimated to affect approximately 9.8 million adults across the US.

The company has been trying for the approval of Intuniv as monotherapy for the treatment of ADHD symptoms throughout the day in children aged 6 to 17 years, with dosage strengths of 1 mg to 4 mg daily.

New Drug Application for Intuniv includes data from two placebo-controlled trials in children and adolescents ages 6 to 17 evaluating safety and efficacy in controlling ADHD symptoms. The effectiveness of Intuniv was evaluated on a once-weekly basis using the ADHD Rating Scale or ADHD-RS-IV, which included both hyperactive/impulsive and inattentive subscales. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment.

The company further noted that Intuniv when given once daily provides a controlled, steady delivery of drug throughout the day and evening. The scientific investigations have shown that guanfacine, the active ingredient in Intuniv, binds selectively to alpha 2A adrenergic cell receptors located in the part of the brain called the prefrontal cortex, which usually controls working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity and frustration tolerance.

The company has plans to add non-stimulant treatment option with a novel mechanism of action and clinical efficacy.

Commenting on the approval from FDA, Matthew Emmens, Chief Executive Officer of Shire said, “When approved, INTUNIV will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks.”

Related Stories

back to top | news index