Shire’s hopes to expand the uses of its big-selling behavioural medicine Vyvanse were dashed after the drug disappointed in a late-stage trial for depression.
Vyvanse (lisdexamfetamine dimesylate) is already Shire’s best performing product with sales of just under $900m for the first nine months of 2013 due to its success as a treatment for attention-deficit/hyperactivity disorder (ADHD).
Shire is attempting to add additional indications for Vyvanse, however, setting up a clinical trial programme investigating its use as an adjunctive treatment for adults with major depressive disorder (MDD) who inadequately responded to monotherapy with either a selective serotonin reuptake inhibitor (SSRI) or serotonin and norepinephrine reuptake inhibitor (SNRI).
Results in the two phase II studies were disappointing though with Vyvanse failing to beat placebo in either study, which investigated a person’s change in depression measured by the Montgomery-Ǻsberg Depression Rating Scale (MADRS).
As a result, Shire said it will no longer pursue Vyvanse in this indication.
The company is still looking to expand the use of Vyvanse to other indications, however, with CEO Dr Flemming Ornskov confirming plans to file the drug for use in the treatment of adults with binge eating disorder.
Nevertheless the negative result is a blow for Shire, which announced just last month it expects to face a $650m loss on the sale of its ulcer treatment Dermagraft.
The company has built much of its business on its ADHD products, which also include the now off-patent Adderall, but Shire is now turning its attention to the growing market of rare diseases.
This includes a restructure of its pipeline, as announced in November last year, as well as the £2bn purchase of rare disease specialist ViroPharma.