A Cephalon Inc. drug to treat attention deficit hyperactivity disorder in children is not acceptably safe and needs more study according to the FDA.
A Food and Drug Administration panel of advisers said that Cephalon's data on the stimulant Sparlon, sold as Provigil for sleep disorders, showed that it was effective, but that questions about the drug's safety outweighed its benefit for ADHD.
The panel's 12-1 vote against recommending approval based on safety concerns was a huge blow to the Frazer biotech. Cephalon sells four drugs and was hoping to take advantage of the large market for ADHD medications taken by millions of children.
