(February 23, 2007) -- The Food and Drug Administration has approved a new amphetamine-based drug called Vyvanse to treat Attention-Deficit/Hyperactivity Disorder (ADHD). Also known as lisdexamfetamine, Vyvanse is manufactured by Shire PLC, which says the drug is harder to abuse than older stimulants.

FDA spokeswoman Susan Cruzan said Shire has tested the drug on adults with a history of abusing stimulants to measure its "likeability" and thus tried to limit the drug's potential for misuse. The drug is said to limit the onset of the effects that normally come from amphetamines.

According to AP reports, the Drug Enforcement Administration has also proposed making it a schedule II controlled substance - keeping it in the category equivalent of cocaine, methadone and other drugs with a high potential for abuse.

Prescriptions for schedule II drugs, including existing ADHD treatments such as Adderall and Ritalin, cannot be called into a pharmacy and physician prescribing patterns are monitored by the U.S. Drug Enforcement Administration.

To reduce the potential for abuse, Vyvanse starts showing results by gradually releasing its active ingredient, d-amphetamine, after the drug has been swallowed and comes into contact with enzymes in the digestive tract. Unless it's swallowed, Vyvanse remains inactive - thus making it useless for abuse by users who snort or inject crushed pills.

As with all ADHD drugs, Vyvanse will carry a strong warning alerting patients to possible cardiovascular and psychiatric risks.

Shire, Britain's third-biggest drugmaker, believes the drug can be a $1 billion a year successor to its top selling ADHD drug, Adderall XR, which is due to lose patent protection in 2009.

Shire plans to launch Vyvanse in the second quarter of 2007 in three once-daily dosage strengths of 30 mg, 50 mg and 70 mg.

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ADHD is a disorder initially appearing in childhood which manifests itself with symptoms such as hyperactivity, forgetfulness, poor impulse control, and distractibility. In neurological terms, ADHD is currently considered to be a persistent and chronic syndrome for which no medical cure is available.

ADHD is believed to affect between 3-5 percent of the United States population, including both children and adults.

Last updated: 02/07

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