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INTUNIV Approved As ADHD Treatment Drug

Shire received FDA approval for INTUNIV ADHD treatment drug.

The Food and Drug Administration (FDA) granted marketing approval Thursday to the biopharmaceutical company Shire. The FDA stated it has approved its extended-release tablet INTUNIV for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years.

A Shire spokeswoman said yesterday that the company would start marketing in "the next several weeks.” US regulators gave Shire, a U.K.-based company and the country's third biggest drug maker, a thumbs up for this once-daily drug that is believed to work by engaging receptors in the prefrontal cortex of patients' brains to treat the symptoms of the disorder.

INTUNIV is a non-stimulant treatment for ADHD in children and adolescents aged 6 to 17. The once-daily formulation of guanfacine is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

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Safety was appraised during the trials and data showed that the adverse side effects reported by participants using INTUNIV were generally mild to moderate in severity, with the most common being sedative in nature.

The Centers for Disease Control and Prevention estimated that In the United States, 8 percent of school-aged children, or about 4.4 million children aged 4 to 17, have been diagnosed with ADHD. There are high hopes that receiving FDA approval for this ADHD drug will not only out Shire on the map, but can be a positive treatment option in ADHD.

"Shire is proud to introduce INTUNIV, providing clinicians, patients, and their families with a novel ADHD treatment option," said Mike Cola, President of Shire Specialty Pharmaceuticals. "This is a complex disorder in which patients may present with multiple symptoms and behaviors that can be disruptive. “

Shire receiving FDA approval for ADHD drug is nothing new since they already have three other ADHD treatments in the United States and two ADHD medicines outside the United States. The excitement for Shire is INTUNIV is the company’s first nonstimulant-based ADHD treatment.

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