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FDA Approves Shire's Once-Daily INTUNIV for the Treatment of ADHD in Children andAdolescents Aged 6 to 17

Thu, 09/03/2009 - 4:36am
Shire plc has received approval from the FDA for INTUNIV(TM) (guanfacine) Extended Release Tabletsfor the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) inchildren and adolescents aged 6 to 17 years. INTUNIV, a once-dailyformulation of guanfacine, is the first selective alpha-2A adrenergicreceptor agonist approved for the treatment of ADHD. Although the mechanismof action is unknown, INTUNIV is thought to directly engage receptors foundin the prefrontal cortex - an area of the brain that has been linked inpreclinical research to ADHD. Stimulation of the postsynaptic alpha-2Areceptors is thought to strengthen working memory, reduce susceptibility todistraction, improve attention regulation, improve behavioral inhibition, andenhance impulse control. "Shire is proud to introduce INTUNIV, providing clinicians, patients, andtheir families with a novel ADHD treatment option," said Mike Cola, Presidentof Shire Specialty Pharmaceuticals. "This is a complex disorder in whichpatients may present with multiple symptoms and behaviors that can bedisruptive. INTUNIV expands the Shire ADHD portfolio with a nonscheduledmedication, allowing clinicians to optimize their overall approach towardmanaging ADHD and may help provide symptom control for children and teenswith ADHD who often have difficulty responding appropriately to everydaysituations and challenges." Once-daily INTUNIV is expected to be available in US pharmacies inNovember and will come in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg).INTUNIV will be marketed in the United States by the existing Shire ADHDsales team of nearly 600 representatives. INTUNIV is not a controlledsubstance and has no known potential for abuse or dependence.

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