Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that results of three abuse liability studies with lisdexamfetamine dimesylate (NRP104), an investigational drug for the treatment of ADHD, were presented last week at the 68th annual meeting of the College on Problems of Drug Dependence (CPDD) in Scottsdale, AZ. Principal investigator Donald Jasinski, Professor of Medicine, Chief Center for Chemical Dependence, Johns Hopkins Bayview Medical Center, presented these results.
New River Pharmaceuticals Inc. (NASDAQ: NRPH) designed lisdexamfetamine dimesylate as an inactive prodrug in which d-amphetamine is bonded to l-lysine, a naturally occurring amino acid. Lisdexamfetamine dimesylate remains inactive until converted and active d-amphetamine is gradually released. On January 31, 2005, New River signed a collaborative agreement with Shire to develop and commercialize the product and on December 6, 2005, filed a New Drug Application with the U.S. Food and Drug Administration to evaluate lisdexamfetamine dimesylate for the treatment of ADHD. This application is currently under review.
Results of "Pharmacokinetics of oral NRP104 (lisdexamfetamine dimesylate) versus d-amphetamine in healthy adults with a history of stimulant abuse"
The A01 study was designed to evaluate the safety, tolerability, and abuse liability of lisdexamfetamine dimesylate in twelve healthy adult volunteers with histories of stimulant abuse.
In this single blind, placebo- and active-controlled, single-dose escalation study, lisdexamfetamine dimesylate tended to be less euphoric than d-amphetamine sulfate 40 mg, and had a later peak effect. The systemic exposure to active d-amphetamine sulfate (AUC and Cmax) was dose proportional following a single administration of lisdexamfetamine dimesylate in doses between 30 mg and 130 mg and was attenuated between 130 mg and 150 mg. Overall, doses of lisdexamfetamine dimesylate from 30 mg to 150 mg w
Contact: Matt Cabrey, Shire