FDA panel rejects recommending approval of CEPH's Sparlon, I'm going to listen to their CC at 6pmEST..edit: no position
PS..we wives/partners know-g-
FDA Panel Rejects ADHD Drug
For Children and Adolescents
By JENNIFER CORBETT DOOREN
March 23, 2006 4:34 p.m.
WASHINGTON -- A Food and Drug Administration panel rejected a proposed drug by Cephalon Inc. to treat children and adolescents with attention deficit hyperactivity disorder on concerns the drug might be linked to a potentially fatal skin condition.
The outside panel of medical experts said that while it believed the drug would be effective at treating ADHD, it simply didn't have enough data on whether the drug could cause Steven Johnson's Syndrome, a severe skin rash that can be fatal.
The proposed drug, Sparlon, is already on the market and is sold at a lower dose to treat sleep disorders under the brand name Provigil.
The panel voted 12 to 1 against the drug as a treatment for ADHD in children and adolescents. The panel suggested Cephalon, based in Frazer, Pa., conduct additional studies of the drug to see if any new cases of Steven Johnson's Syndrome or SJS occur.
Based on limited data, FDA officials said the rate of SJS seen in the Sparlon clinical trials is roughly 1 in 1,000, a rate that's much higher than the rate that would be expected in the general population.
Clinical data presented at the meeting suggested Sparlon was linked one possible case of SJS out of almost 1,000 patients who were studied.
Estimates of the rate of SJS that would be seen in the general population ranged from 1 in 100,000 to one in one million.
"I don't know what to make exactly of that one case," said Wayne Goodman, the panel's chairman and the chairman of the psychiatry department at the University Florida College of Medicine. "I'm not willing to find the risk acceptable without additional data."
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com |
