Zacks_Analysts' Blog : Shire Reports Positive Data - Analyst Blog

Shire (SHPGY) recently announced encouraging data from a phase II trial evaluating Vyvanse (lisdexamfetamine dimesylate) as an add-on treatment in adults with remission (both partial and complete) of recurrent major depressive disorder (“MDD”) and significant and persistent cognitive impairments.

The study was conducted on 143 MDD patients who were on antidepressant monotherapy for at least 8 weeks. Results revealed that Vyvanase was superior to placebo. Vyvanse is currently marketed for Attention-Deficit/Hyperactivity Disorder (“ADHD”) in children aged between 6 to 17 years and adults. However Vyvanse is not approved as a monotherapy and should be used as part of a total treatment program that may include counselling or other therapies.

We would like to remind investors that Vyvanse is a federally controlled substance due to its abuse potential. Misuse of Vyvanse may cause sudden death and serious heart problems. Vyvanse should not be taken by patients suffering from heart diseases, moderate to severe high blood pressure, overactive thyroid gland (hyperthyroidism),  glaucoma, agitated states, a history of drug abuse and patients on an anti-depression medicine called a monoamine oxidase inhibitor (“MAOI”) within the last 14 days. Patients who are sensitive to, are allergic to or have suffered a reaction to stimulant medicines are also advised against the intake of Vyvanse.

Major depressive disorder is a mental disorder characterized by a recurrent low mood, loss of interest, absence of pleasure, feelings of guilt, low self-worth, disturbed sleep, lack of appetite, low energy and poor concentration. Currently, almost 66% of the MDD patients who are treated with antidepressants as monotherapy experience inadequate relief. In most cases, the symptoms persist with respect to their mood, concentration, motivation and interest reflecting a need for comprehensive treatment.

Our Recommendation

We currently have a Neutral recommendation on Shire. The stock carries a Zacks #3 Rank (Hold rating) in the short run.