Sleep Disorders Drug Closer to Approval
Posted on: Monday, 24 October 2005, 15:00 CDT
By Michelle Fay Cortez Bloomberg News
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.
Source: Deseret News (Salt Lake City)
Related Articles
- GlaxoSmithKline and Shire Enter Agreement to Co-Promote Vyvanse(R) (lisdexamfetamine dimesylate) CII for Adult Attention Deficit Hyperactivity Disorder
- Hayes Evaluates Test and Treatment Options for Attention-Deficit Hyperactivity Disorder
- Shire Re-Launches ADHDSupport.Com, a Virtual Road Map Providing Information, Tools and Practical Tips About Attention Deficit Hyperactivity Disorder (ADHD)
- Global Sales of ADHD Drugs Are Forecast to Reach US$4.3 Billion By 2012 - Market Research Available on CNS Drug Discoveries 2006: Attention Deficit Hyperactivity Disorder
- Family Ties: Major Research Findings Show Strong Familial Link to Attention Deficit Hyperactivity Disorder (ADHD)
- Shire's DAYTRANA(TM), First Transdermal Medication for Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children, Now Available in Pharmacies
- U.S. Advisors Recommend Safety Warnings Against Attention Deficit Drugs
- Deaths Tied to Attention-Deficit Drugs
- Canada Reinstates Attention-Deficit Drug
- Drug Firm to Pull Attention Deficit Drug
 |
 |
User Comments (0)
RSS Feeds