Shire’s Vyvanse fails endpoint in two Phase III major depressive disorder studies

10th February 2014 (Last Updated February 10th, 2014 01:00)

Shire has reported that Vyvanse did not meet the primary efficacy endpoint versus placebo in two pivotal Phase III investigational trials evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) to treat major depressive disorder (MDD) in adults.

Shire has reported that Vyvanse did not meet the primary efficacy endpoint versus placebo in two pivotal Phase III investigational trials evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) to treat major depressive disorder (MDD) in adults.

However, according to the top-line results, its safety profile appears to be generally consistent with the known profile established in studies in adults with attention-deficit/hyperactivity disorder (ADHD).

The company said that based on these clinical trial results, it will no longer pursue the clinical development programme.

In late-2014, the company intends to file for a new indication with the FDA for Vyvanse in binge eating disorder in adults.

"Rare diseases is an area of great unmet patient need and it's where we will increasingly focus our strategic development and investment."

Shire chief executive officer Flemming Ornskov said: "Shire's portfolio of treatments in rare diseases is also growing, strengthened recently with the acquisition of ViroPharma.

"Rare diseases is an area of great unmet patient need and it's where we will increasingly focus our strategic development and investment."

Vyvanse is currently approved as a prescription medicine for the treatment of ADHD in the US, Canada, Australia, several European countries under the trade name 'Elvanse/Tyvense, and as Venvanse in Brazil.

The company said that Vyvanse should only be used in accordance with locally approved prescribing information.

Each of the two identically designed Phase III, multi-centre, randomised, double-blind, parallel-group, placebo-controlled, dose-optimised studies were designed to evaluate the efficacy, safety, and tolerability of Vyvanse in patients aged 18 to 65 who met DSM-IV-TR criteria for a diagnosis of MDD.

In the first study, 404 adults were randomised and 426 adults were given Vyvanse in the second study.

The primary efficacy endpoint for the trials was defined as the change from augmentation baseline (week eight) to week 16 in Montgomery-?sberg Depression Rating Scale (MADRS) total score.

Safety and tolerability of the drug were assessed based on treatment-emergent adverse events (TEAEs), vital signs, weight, clinical laboratory results, and electrocardiogram (ECG) results.

In the SPD489-322 trial, three patients treated with Vyvanse and five patients treated with placebo experienced serious adverse events (SAEs), while eight patients on Vyvanse and seven patients on placebo had TEAEs that led to study discontinuation.

In the SPD489-323 trial one patient treated with Vyvanse and one patient treated with placebo experienced serious adverse events (SAE), with two patients on Vyvanse and one patient on placebo had treatment-emergent adverse events (TEAEs) that led to study discontinuation.