The USA’s Cephalon has received an approvable letter from the US Food and Drug Administration regarding its supplemental New Drug Application for Sparlon (modafinil) in treating attention-deficit hyperactivity disorder in children and adolescents aged six to 17.
The company did not divulge the nature of the requirement it needs to fulfill before gaining the final green light to sell the drug, but shares in the group climbed 2.6% to close at $45.45 on October 21, as investors welcomed the news that it now expects to launch Sparlon, a once-daily version of its established narcolepsy treatment, Provigil, in early 2006.
Confidence in the agent was also boosted by analysis of safety and efficacy data from three pivotal trials in over 600 children and adolescents, which showed significant improvement versus placebo as early as the first week, with continued improvement during titration and dose maintenance, the company said.
