Shire (SHPGY) recently announced that the marketing application of Venvanse (lisdexamfetamine dimesylate) for Attention-Deficit/Hyperactivity Disorder (ADHD) has been accepted for review in Europe. The application will be reviewed by the UK based agency, Medicines Healthcare products Regulatory Agency (MHRA), which will act as the reference member state for this decentralised procedure (DCP). The DCP will initially comprise eight European nations.
The application was filed following completion of the European phase III study which evaluated Venvanse in children and adolescents (aged 6 to 17 years) suffering from ADHD. Shire released positive top-line data from the randomised, double-blind, placebo and active controlled safety and efficacy study in October 2011.
Venvanse is currently marketed for ADHD in children, adolescents and adults in the US and Canada under the trade name Vyvanse. The product is also marketed in Brazil for the treatment of ADHD in children.
We note that Venvanse is a federally controlled substance due to its abuse potential. Misuse of Venvanse may result in serious heart problems and may even prove to be fatal. Venvanse should not be taken by patients suffering from heart diseases, moderate to severe high blood pressure, overactive thyroid gland (hyperthyroidism) and glaucoma. Furthermore, the drug should NOT be used to treat patients in agitated states, those with a history of drug abuse and those who have taken a monoamine oxidase inhibitor (anti-depressant) within the last 14 days. Moreover, patients sensitive or allergic to stimulants should also avoid Venvanse.
Our Recommendation
We currently have a Neutral recommendation on Shire. The stock carries a Zacks #3 Rank (Hold rating) in the short run.
SHIRE PLC-ADR (SHPGY): Free Stock Analysis Report
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