New adult ADHD drug receives FDA approval
The U.S. Food and Drug Administration has approved the first prodrug designed for once-daily treatment of adults with ADHD.
Although ADHD -- attention deficit-hyperactivity disorder -- is often thought of as a childhood malady, it's estimated 4.4 percent of U.S. adults ages 18-to-44 suffer from it. The new drug, Vyvanse, has been marketed in the United States since July 2007 for the treatment of ADHD in children 6-12 years of age.
The manufacturer, Shire PLC, a British-headquartered specialty biopharmaceutical company, said Vyvanse is the only once-daily prodrug stimulant approved to treat adults with ADHD. A prodrug is a medication designed to be inactive until it interacts with enzymes in the stomach, thereby making it difficult to be abused, a Shire spokesman said.
In a clinical study with adults, Vyvanse was shown to significantly improve ADHD symptoms, such as an inability to focus attention, hyperactivity and impulsivity, within the first week of use, Shire officials said.
The company said Vyvanse is now available in dosage strengths of 30 mg, 50 mg and 70 mg. Additional dosage strengths of 20 mg, 40 mg and 60 mg are expected to become available later this year.
Copyright 2008 by United Press International