Sleep Disorders Drug Closer to Approval
Cephalon Inc. said Friday it moved closer to U.S. approval for marketing a version of its Provigil sleep-disorders drug, the company’s best-selling medicine, to treat attention-deficit disorder in children.
The U.S. Food and Drug Administration sent a so-called approvable letter for Sparlon, a new formulation and dose of Provigil, Cephalon said in a statement Friday. Sales of Sparlon probably will begin in early 2006, the company said. An approvable letter spells out steps for getting final approval from the FDA to begin marketing.
“In the spectrum of approvable letters, this is a good one, as the company does not need to do additional studies,” said Marc Goodman, an analyst for Morgan Stanley & Co. in New York, in a note to investors.
Sparlon, originally developed under the brand name Attenace for the attention disorder, may generate an additional $180 million in 2006 sales for that use and as much as $450 million in 2008, said Credit Suisse First Boston analyst Ken Kulju in a note to clients. Cephalon, based in Frazer, Pa., and with operations in Utah, last month said it reached an agreement with Johnson & Johnson, the maker of thousands of products from Band-Aids to surgical implants, to help market Sparlon.
Sparlon is intended for children ages 6 to 17 with attention- deficit hyperactivity disorder, or ADHD. Johnson & Johnson’s 300 sales representatives who sell that company’s Concerta for the disorder will also pitch Sparlon to pediatricians, the companies said Sept. 1.
Three studies of the drug, involving more than 600 children, found Sparlon led to significant improvement in symptoms in less than a week. Side effects, often a problem with attention-deficit drugs, were insomnia, headache and decreased appetite.
The mild side effects caused by Sparlon may help sales, said Kulju, especially after Eli Lilly & Co. warned last month that its attention-deficit drug Strattera may raise the risk of suicidal thoughts in children.
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