Vyvanse drug meets Phase 2 study endpoints: Shire reports

29th April 2012 (Last Updated April 29th, 2012 18:30)

Shire, a specialty biopharmaceutical company, has reported the positive data from the Phase 2 study of its Vyvanse (lisdexamfetamine dimesylate) capsules, (CII) in adults with binge eating disorder.

lisdexamfetamine dimesylate capsules

Shire, a specialty biopharmaceutical company, has reported positive data from the Phase 2 study of its Vyvanse (lisdexamfetamine dimesylate) capsules (CII), in adults with binge eating disorder.

Vyvanse is a prescription medicine currently approved in the US and Canada, as well as in Brazil under the name Venvanse, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

The Phase 2 multi-centre randomised double-blind parallel-group placebo-controlled forced-dose titration study determined the efficacy of Vyvanse in 270 adults aged 18 to 55 who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for binge eating disorder.

The study included a two-week screening period, 11-week double-blind treatment phase and one-week follow-up phase.

In the trial, patients were randomised to one of four treatment groups: Vyvanse 30, 50, or 70mg/day or placebo, and the safety and tolerability of all the doses was evaluated based on occurrence of treatment-emergent adverse events (TEAEs), vital signs, weight, clinical laboratory results, electrocardiogram (ECG) results, and the Columbia-Suicide Severity Rating Scale (C-SSRS).

The primary end point of the study was the change from baseline to week 11 in log transformed (number of binge days per week + 1), and found that Vyvanse 50mg and 70mg were superior to placebom, while 30mg dose was not superior to placebo.

Shire specialty pharmaceuticals and regenerative medicine businesses research and development senior vice president Jeffrey Jonas said the company intends to submit the data to the regulatory agencies for completion of a clinical development programme for Vyvanse as a treatment for patients suffering with binge eating disorder.

"After reviewing our data we will also explore opportunities for identifying biomarkers to aid in the diagnosis and treatment of patients with binge eating disorder," Jonas added.

The company plans to conduct additional larger studies to confirm the validity of the Phase 2 study data following discussions with the US Food and Drug Administration.

 

Image: 50 and 70mg Vyvanse capsules of Shire demonstrated considerable superiority over placebo. Photo: Champlax.