CHMP Recommends ADHD Drug for Approval

Megan Brooks

Disclosures

July 24, 2015

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving guanfacine (Intuniv, Shire Pharmaceuticals Ireland Ltd) to treat attention-deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years who fail to respond adequately or cannot tolerate stimulant medication.

Guanfacine, like other drugs approved for ADHD, should only be used as part of a comprehensive treatment program typically combining psychological, educational, and social measures, the EMA notes in a news release. It also recommends the drug be prescribed by a specialist in childhood and/or adolescent behavioral disorders.

Guanfacine is a nonstimulant selective alpha2–adrenergic agonist "expected to improve the symptoms of ADHD by initiating a response from neurons in regions of the brain associated with attention, organization, planning and impulse control," the EMA explains.

The positive opinion on guanfacine was based on 13 studies, including five pivotal studies, that provided evidence on the safety and efficacy in children and adolescents "showing improvements for a number of disease parameters associated with symptom reduction," the EMA says.

The most serious side effects were the risk for bradycardia, hypotension, syncope, somnolence, and sedation and the associated risk for falls and accidents. Treatment with guanfacine was also associated with weight gain. "Measures have been put in place to minimize those risks at the beginning and during treatment with Intuniv," the EMA notes in the release, without elaborating on those measures. Shire will conduct a postauthorization safety study to further confirm the long-term safety profile of guanfacine in children with ADHD, the agency says.

The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization. Once that has been granted, each member state will make a decision about price and reimbursement on the basis of the potential role/use of the medicine in the context of its national health system.

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