Vyvanse Capsules CII administration through 2 routes demonstrated similar pharmacokinet... (ransit times. ADHD stimulant products a...)

Vyvanse Capsules CII administration through 2 routes demonstrated similar pharmacokinetic profile

Date:10/22/2009

ransit times. ADHD stimulant products are classified as schedule II controlled substances because a high potential for abuse exists.

About the Study This open-label, two-period, crossover study compared the pharmacokinetics of d-amphetamine, the active medication derived from Vyvanse, in 18 healthy men after single administration through nasal and oral routes. The primary objectives of the study were to determine whether Vyvanse is absorbed after intranasal delivery and to assess the extent of absorption and conversion to d-amphetamine, specifically whether administration through the nose would alter the rate and extent of absorption. A secondary study objective was to evaluate the safety of Vyvanse administered as a single oral dose and a single intranasal dose.

In the study, investigators randomly assigned participants to receive a single nasal or oral dose of Vyvanse 50 mg, then, at least seven days later, the subjects received the opposite regimen. Results showed that the rate and extent of d-amphetamine exposure were similar in the healthy participants who received a single 50-mg dose of Vyvanse either through the nose via a solution formulation or orally in capsule form. Specifically, the median time to maximum plasma concentration of d-amphetamine was five hours after oral administration of Vyvanse and four hours after intranasal administration of Vyvanse. Maximum plasma concentration for intranasal administration and oral administration of Vyvanse were similar (35.9 ng/mL versus 37.6 ng/mL, respectively).

In this study, treatment-emergent adverse events were mild to moderate in severity and consistent with known effects of amphetamine. The most common adverse events with an incidence greater than 5 percent among subjects administered Vyvanse by intranasal administration were: tachycardia (two of 18 subjects), dry mouth (two of 18 subjects), and feeling jittery (two of 18 subjects), and for oral administration: anore
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Contact: Matthew Cabrey, Shire
484-595-8248
Porter Novelli
Source:Eurekalert

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