US FDA approves additional dosage strengths of Shire’s ADHD Treatment Vyvanse™ (lisdexamfetamine dimesylate) which may help physicians tailor treatment for Individual patients to date, more than 500,000 total prescriptions have been dispensed for Vyvanse 30, 50 and 70 mg

Shire plc,  the global specialty biopharmaceutical company, has received approval from the U.S. Food and Drug Administration for three additional dosage strengths for the attention deficit hyperactivity disorder (ADHD) treatment, Vyvanse™ (lisdexamfetamine dimesylate). Shire expects the three additional dosage strengths of 20 mg, 40 mg and 60 mg will be available in retail pharmacies in the second quarter of 2008 to supplement the existing 30 mg, 50 mg and 70 mg dosage strengths currently available in pharmacies throughout the country.

Dose titration, the process of incrementally increasing or decreasing the dose of a medication, is a widely used method in clinical practice to help achieve optimal efficacy and tolerability for each patient. The option of having dosage strengths with smaller increments allows for a more gradual titration of medication and may help the physician tailor the treatment for each individual patient.

Vyvanse is currently approved in the United States for the treatment of ADHD in children aged 6 to 12 years. A Supplemental New Drug Application (sNDA) for Vyvanse for the treatment of ADHD in adults is currently under review by the FDA.
Vyvanse is a therapeutically inactive prodrug, in which d-amphetamine is covalently bonded to l-lysine, and after oral ingestion it is converted to pharmacologically active d-amphetamine. The conversion of Vyvanse to d-amphetamine is not affected by gastrointestinal pH and is unlikely to be affected by alterations in normal GI transit times.