Shire Reports Positive Signal Finding Study of Investigative Use of Vyvanse Capsules

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Shire plc, the global specialty biopharmaceutical company, today announced results from a study of Vyvanse®, assessing its effect in a model for Excessive Daytime Sleepiness (EDS).  Vyvanse is a prescription medicine currently approved in the US, Canada and Brazil for the treatment of ADHD.  Vyvanse should only be used to treat ADHD. In this investigational, single dose, single-site, randomized, placebo- and active-controlled study, 135 subjects received Vyvanse 20 mg, 50 mg, 70 mg, placebo or the active comparator (armodafinil 250 mg (NUVIGIL®)). On the primary end point, all groups improved objective wakefulness as compared to placebo (p < 0.0001). Additional pre-specified analyses showed that Vyvanse 70 mg demonstrated statistically significant improvement in objective wakefulness compared to armodafinil. No significant difference was demonstrated between Vyvanse 50 mg and armodafinil. Vyvanse 20 mg was demonstrated as inferior to armodafinil. No conclusions of comparability between Vyvanse and armodafinil can be drawn from this signal finding study. However, based on these findings Shire plans to review potential development pathways with health authorities for Vyvanse as a possible EDS treatment option. Excessive Daytime Sleepiness is a syndrome characterized by persistent sleepiness. It may be caused by environmental factors (e.g., insufficient sleep or non-conventional work schedules) or certain medical disorders (e.g., narcolepsy). Dr. Thomas Roth, Division Head of Sleep Medicine at The Henry Ford Sleep Disorders and Research Center said, It is estimated that several million people in the US are affected by EDS. Research such as this may provide clinicians with new therapeutic options in the management of this clinically important symptom. Jeffrey Jonas, MD, Senior Vice President of Research and Development for Shire’s Specialty Pharmaceuticals business said, Shire is committed to exploring potential new uses for Vyvanse as a dopamine modulator. We have plans to review potential development pathways with health authorities for Vyvanse as a possible EDS treatment option. Vyvanse is a prescription medicine currently approved in the US for the treatment of ADHD.  Efficacy in ADHD was based on two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and two controlled trials in adults. Vyvanse should be used as part of a total ADHD treatment program that may include counseling or other therapies. Vyvanse is a stimulant medication and federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law. Misuse of stimulants may cause sudden death and serious cardiovascular adverse events.

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