Shire receives approvable letter for Intuniv

Shire Pharmaceuticals has received an approvable letter from the US Food and Drug Administration (FDA) regarding Intuniv, a potential monotherapy for the treatment of attention deficit hyperactivity disorder (ADHD).

According to Shire, Intuniv is not a controlled substance and does not have a “known mechanism” for dependence or abuse and its use has been studied in both children and adolescents.

“The FDA’s approvable letter for Intuniv is positive news and Shire will be working closely with the agency to address its questions,” said Matthew Emmens, chief executive officer of Shire.

Mr Emmens continued by saying that when Intuniv is approved it will become the first medication to treat ADHD by targeting alpha-2A-receptors in the prefrontal cortex selectively.

Shire also said that the non-stimulant treatment “may be ideal” for patients who have not benefited from the ADHD medicine that is currently available on the market.

According to mental health charity Mind, the latest statistics suggest that five per cent of school children in the UK show the symptoms of ADHD.