Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced the acceptance for review of their once-daily ADHD medicinal product VENVANSE® (lisdexamfetamine dimesylate) by the Medicines Healthcare products Regulatory Agency (MHRA), UK. The MHRA have agreed to act as the Reference Member State for this Decentralised Procedure (DCP) which will initially include eight European countries.This application follows the successful completion of the European Phase 3 study of VENVANSE in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) last year.

VENVANSE® is the first long-acting prodrug stimulant and is currently commercialized in the US, and Canada for the treatment of ADHD in children, adolescents and adults (under the tradename VYVANSE®) and in Brazil for the treatment of ADHD in children (under the trade name VENVANSE®).

“The regulatory submission of VENVANSE in Europe is an important milestone for Shire and for physicians in the EU who are seeking alternative treatments to help their patients diagnosed with ADHD,” said Mike Yasick, Senior Vice President of Shire’s ADHD business unit. “VENVANSE is an approved ADHD treatment in the US, Canada and Brazil and has become an important resource for physicians when helping their patients manage their ADHD symptoms, We look forward to making this treatment available in Europe.”

A randomised, double-blind, multicentre, parallel-group, placebo- and active controlled, dose-optimisation, safety and efficacy study in 336 children and adolescents aged 6 to 17 years (data from this study were publicly disclosed on October 21st at the AACAP congress 2011 in Toronto)

About lisdexamfetamine dimesylate

VENVANSE (LDX) is available as a prescription-only medicine in the USA (brand name VYVANSE® ; approved for the treatment of ADHD in children and adolescents  aged 6 to 17 and adults), Canada (brand name VYVANSE®  (available for use in children and adolescents aged 6 to 17 and adults) and Brazil (VENVANSE™; approved for children aged 6-12 years)

LDX should be used as part of a total treatment program that may include counseling or other therapies.

LDX is a prodrug of dextroamfetamine.  After oral administration, LDX is rapidly absorbed from the gastrointestinal tract and hydrolyzed primarily in whole blood to dextroamfetamine, which is responsible for the drug’s activity. 

The safety and tolerability profiles of LDX are generally consistent with those of other CNS (central nervous system) stimulant medications, the most common side effects being decreased appetite, insomnia, abdominal pain, headache, and irritability.

For safety information, please contact Shire’s medical information office at medinfoglobal@shire.com.