Shire drops drug’s new use after phase three disappointment
News
Shire's ADHD drug lisdexamfetamine (Vyvanse) failed to meet endpoints in two phase three trials evaluating a new role in depression.
The "disappointment" has led the company to decide to drop further investigation for the extended indication.
"While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in binge eating disorder in adults, and Vyvanse is an effective and leading treatment for ADHD."
Flemming Ornskov, chief executive, Shire.
Related news:
Shire ends research into Vyvanese's use in depression (The Wall Street Journal).
Shire's ADHD drug Vyvanse fails in trial to treat depression (Reuters).
Reference links:
Shire reports top-line results from two phase 3 studies for Vyvanse (lisdexamfetamine dimesylate) capsules (CII) as an adjunctive treatment for adults with major depressive disorder (Shire press release).
