Last October, the FDA sent an "approvable" letter to Cephalon for the pediatric use of Sparlon pending a March 23, 2006, meeting of the Psychopharmacologic Drugs Advisory Committee to review the drugs approval.
Modafinil-based Provigil is currently only approved for narcolepsy, sleep apnea and shift work sleep disorder, according to the FDA. However, it is estimated that half of all Provigil prescriptions are written for off-label use.
"Doctors now prescribe it to treat everything from attention deficit hyperactivity disorder (ADHD) to fatigue associated with multiple sclerosis and depression," according to the November 1, 2004 Business Week Online.
In addition, the Cephalon will get a 6-month extension of that agreement if it wins a pediatric approval for the drug, according to documents filed with the Securities and Exchange Commission.
With Sparlon's application to FDA approval, Cephalon claimed 3 studies involving more than 600 children aged 6 to 17, found the drug to be more effective than a placebo.
Each of the Sparlon studies lasted only 9 weeks and the most common side effects listed were mild insomnia, headaches and loss of appetite. Sparlon was "generally well-tolerated," Cephalon reported.
What does "generally well-tolerated," mean? Tolerated better than what? A placebo?
One study of 248 patients was published in December 2005 issue of Pediatrics, and said Sparlon's effectiveness and safety profile, along with its low potential for abuse, may offer doctors and parents a new option for children and adolescents with ADHD.
However, because the study only lasted 9 weeks, the authors said they did not know if "the initial benefits will be sustained over longer periods of time," and called for more research to assess the "longer-term efficacy and safety."
Dr DuBose Ravenel, MD, who will testify on behalf of the International Center for the Study of Psychiatry and Psychology at the advisory committee hearing on March 23, makes the point that although 48% of drug treated subjects at final follow-up were "much" or "very much" improved clinically, 52% were not.
This is a substantially lower response rate than has been reported for traditional stimulants, the doctor notes.
Dr Dubose Ravenel is a pediatrician with 25 years experience in private practice with
a heavy emphasis upon behavioral issues, including diagnosing and managing ADHD.
In addition, he notes, with regard to potential conflicts of interest, itemized conflicts for each of the Pediatric studys authors are numerous.
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