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April 08, 2007

New Treatment for ADHD: “Vyvanse”

Generic Name: lisdexamfetamine dimesylate
Date of Approval: February 23, 2007
Company: Shire plc and New River Pharmaceuticals Inc.

The U.S. Food and Drug Administration has granted marketing approval for Vyvanse (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder.
Vyvanse is a pro-drug that is therapeutically inactive until metabolized in the body’s digestive tract. In several clinical studies designed to measure duration of effect, Vyvanse provided significant efficacy compared to placebo for a full treatment day, up through 6:00 pm. Additionally, when Vyvanse was administered in two clinical human drug abuse studies, it produced subjective responses on a scale of "Drug Liking Effects" (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.
The FDA has projected that Vyvanse be classified as a Schedule II (or in parent, user friendly terms “carbon copied” prescription) controlled substances. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). Once the final scheduling designation is complete, product launch is anticipated in the second quarter of 2007. Vyvanse will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.
Vyvanse developed by New River, as a new ADHD medication is designed specifically to provide a lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. This combination rapidly absorbs into the body from the gastrointestinal tract and converted to d-amphetamine, which is where the drugs activity starts to work.

Vyvanse Significantly Controls ADHD Symptoms
Information from phase II and III clinical trials verified statistically substantial improvements in ADHD symptoms for patients aged 6 to 12 years treated with Vyvanse compared to those treated with placebo. These studies proved that all doses of Vyvanse (30 mg, 50 mg and 70 mg) provided significant efficacy at all time points tested, including 6pm.
In the phase II, analog classroom study, patients demonstrated significantly improved behavior when receiving either Vyvanse or Adderall XR(r) (mixed salts of a single-entity amphetamine product) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD. Both treatments resulted in significantly improved behavior versus a placebo. Patients also demonstrated significantly improved academic productivity with both treatments, compared to placebo, as measured by Permanent Product Measure of Performance (PERMP), an age-adjusted collection of math problems that measures a child's ability to pay attention and stay on task as demonstrated by an increase in the number of attempted and successfully completed problems.
In the phase III, randomized, double-blind placebo-controlled study, all three doses of Vyvanse demonstrated momentous improvements in ADHD Rating Scale scores compared with placebo after four weeks of once-daily treatment.
Additionally, in a study presented in October at a major scientific meeting, Vyvanse yielded a 60 percent improvement in the primary rating scale scores for symptoms of ADHD in children aged 6 to 12 years who received six months of treatment in an open-label phase III study. Results also demonstrated that at 6 months, 95 percent of children taking Vyvanse produced a "much improved" or "very much improved" rating on the Clinical Global Impressions - Improvement score.

By: Margo Richter

Source: http://www.shireadhdtreatments.com/

Posted by margo at April 8, 2007 07:57 PM

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