Cephalon's Next Big Thing

However, Strattera's label contains a black box warning about suicidal thinking, and the label also has been strengthened to caution patients about potential liver problems. After a promising start, Strattera has stumbled. Last year's sales of $552 million fell 17% from 2004.

Recently, Cephalon has been reminding analysts and journalists about favorable cardiovascular data from company-sponsored clinical trials for modafinil, including three presentations at medical conferences in recent years.

"Management expressed confidence in the cardiovascular profile of modafinil and predicted [a] positive outcome from the [March 23] advisory committee meeting," says David Windley of Jefferies & Co., who issued a research report a day after a Cephalon teleconference last month. Windley, who recently raised his rating to buy from hold, doesn't own shares of Cephalon.

When Cephalon asked the FDA in December 2004 to approve Sparlon, its application contained the results of three clinical trials involving children ages 6 to 17. The data showed improvements in those taking Sparlon vs. the placebo, based on daily dosages of 340 milligrams and 425 milligrams.

The standard dose for Provigil is 200 milligrams a day. Provigil is a Schedule IV controlled substance, according to the Drug Enforcement Administration, the second mildest category among DEA drugs.

Each of the Sparlon studies lasted nine weeks. The most common side effects included mild insomnia, headaches and loss of appetite. The drug was "generally well-tolerated," Cephalon says.

One study, with 248 patients, was published in December in Pediatrics, the official journal of the American Academy of Pediatrics. The authors of the study 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.

Because their study lasted only nine weeks, the authors said they didn't know if "the initial benefits will be sustained over longer periods of time." They called for more research to assess the "longer-term efficacy and safety."

Last October, Cephalon employees and an independent heart-failure expert presented data at a medical conference showing Sparlon patients experienced "no statistically significant or clinically meaningful changes" in blood pressure, heart rate or heart-rhythm measurements.

Cardiovascular side effects were statistically similar between patients taking Sparlon and those receiving a placebo. The authors pooled the results of three clinical trials, each lasting nine weeks, analyzing 633 children ages 6 to 17.

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