Ireland-based Alkermes has started a major clinical development programme for ALKS 5461, a once-daily, oral investigational medicine with a new mechanism of action for the adjunctive treatment of major depressive disorder (MDD).

The clinical programme called FORWARD (Focused On Results With A Rethinking of Depression), comprises of a total of 12 studies, including three core Phase III efficacy studies and nine supportive studies.

The first FORWARD trial, evaluating the onset of clinical effect, safety and tolerability of ALKS 5461 in about 60 patients with MDD, has already started, and the three core efficacy studies are scheduled to begin in mid 2014.

The FORWARD pivotal programme is designed to assess the safety and efficacy of ALKS 5461 in patients suffering from MDD who have had an inadequate response to commonly prescribed drugs, including selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs).

Following study results, the company intends to use safety and efficacy data from the FORWARD studies as the basis for a new drug application (NDA) to be submitted to the US Food and Drug Administration (FDA).

Alkermes chief medical officer Elliot Ehrich said with a novel mechanism of action and fast-track designation from the FDA, ALKS 5461 is designed to offer a new treatment option for the millions of people with MDD with urgent unmet medical needs.

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"The comprehensive FORWARD programme incorporates state-of-the-art design elements for depression trials and will be conducted in collaboration with leading clinical investigators," Ehrich said.

"The comprehensive FORWARD programme incorporates state-of-the-art design elements for depression trials and will be conducted in collaboration with leading clinical investigators."

The three core efficacy studies under the FORWARD programme will use advanced methodologies to reduce the impact of clinically meaningful placebo response and are expected to randomise a total of about 1,500 patients with MDD who have had an inadequate response to standard therapies.

The change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) scores will be the primary efficacy endpoint for the three core efficacy studies.

In April 2013, the company has released positive data from a Phase II randomised, double-blind, multicenter, placebo-controlled study of ALKS 5461 in 142 patients with MDD who had an inadequate response to a stable dose of either an SSRI or an SNRI.

The results showed that ALKS 5461 was generally well tolerated and significantly reduced depressive symptoms across a range of standard measures, including the Hamilton Depression Rating Scale, MADRS and the Clinical Global Impression – Severity Scale.

Previously, the FDA granted fast-track status for ALKS 5461 for the adjunctive treatment of MDD in patients with an inadequate response to standard therapies.

Image: ALKS 5461 is a proprietary investigational oral medicine for the treatment of MDD. Photo: courtesy of