said Thursday that the Food and Drug Administration has delayed approving a new treatment for attention deficit hyperactivity disorder.
Shire didn't provide details, but it said the FDA wants additional information on the medication, which "was not unexpected." The drug, called Intuniv, is different than Shire's other ADHD drugs because it isn't a stimulant or a controlled substance.
Intuniv is an extended-release version of a generic blood-pressure pill called guanfacine. Shire is seeking its approval as a once-a-day treatment for children ages six to 17. During its development, the drug had been called Connexyn and SPD503.
"Shire will be working closely with the agency to address its questions," said CEO Matthew Emmens. The nonstimulant drug "may be ideal for those patients who have not benefited from currently available ADHD medications."
Stimulant ADHD drugs from Shire are
Vyvanse, Adderall XR and Daytrana. Vyvanse will be available in July.
In May, Shire
received conditional approval from the FDA for SPD465, an ADHD drug for adults. The company said it is "evaluating its options" for the product.
Shire's stock was recently off 31 cents to $72.25.