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FDA approves drug for drooling

The US Food and Drug Administration has approved Shionogi Pharma's Cuvposa oral solution to treat chronic severe drooling in children

The US Food and Drug Administration (FDA) has approved Shionogi Pharma's Cuvposa (glycopyrrolate) oral solution to treat chronic severe drooling in children who suffer from neuromuscular dysfunction related to neurologic disorders. The drug is cleared for children aged three years to 16 years.

Glycopyrrolate, which was cleared for US marketing decades ago in tablet form as a treatment for peptic ulcers, was already frequently used off-label for the paediatric drooling indication, as it lowers the volume of saliva produced in the mouth.

The new approval is the result of a 2001 advisory committee meeting convened by the FDA "to discuss how best to develop products for drooling with ethically and scientifically sound trials in children who have neurological disorders," the agency said.

Cuvposa is a flavoured oral solution designed for ease of use in paediatric patients. When the drug was used off-label, the tablets had to be crushed and mixed with fluid, which was unpalatable to some children and also often resulted in inexact dosing.

Clinical trials of Cuvposa showed that 78 per cent of the children taking the active drug had clinical improvement in drooling, versus 19 per cent of the placebo group.

29th July 2010

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