Billy
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 Posted: 06/27/07 - 08:48 Post subject: FDA Approves INTUNIV (guanfacine) for the Treatment of ADHD |
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FDA has approved the use of INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), for treatment of Attention-Deficit/Hyperactivity Disorder in children and adolescents. Unlike the drugs used so far, Intuniv is a nonstimulant selective alpha-2A-receptor agonist that has no known mechanism for potential abuse or dependence.
Intuniv targets alpha-2A-receptors in the prefrontal cortex, a brain area thought to manage executive functioning tasks. The researchers are looking to introduce this novel mechanism of action in addition to the existing ADHD medications and offer it to patients who have not benefited from currently available ADHD medications.
Intuniv is planned as a monotherapy for children aged 6 to 17 years, with dosage strengths of 1 mg to 4 mg daily. Its steady delivery throughout the day and evening was found to minimize the fluctuations between peak and trough concentrations as seen with immediate-release guanfacine. The brain area this drug is to assess is associated with executive functioning like working memory, behavioral inhibition, regulation of attention, distractibility, impulsivity, and frustration tolerance.
Two clinical trials and the use of ADHD Rating Scale showed possible adverse events such as somnolence, fatigue, upper abdominal pain, sedation and headache. |
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