The studies are designed to assess the efficacy and safety 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).
About two-thirds of patients who are diagnosed with MDD do not adequately respond to initial antidepressant therapy.
Alkermes chief medical officer Elliot Ehrich said FORWARD-3 and FORWARD-4 incorporate features from the company’s previous successful studies of ALKS 5461, including state-of-the-art design elements to reduce the impact of placebo response in depression trials.
"With these study initiations, four of the 12 studies from the FORWARD program are now underway since the launch of the pivotal program in March," Ehrich said.
Collectively, about 1,000 patients are expected to be randomized in these Phase III, multinational, randomized, double-blind, placebo-controlled FORWARD-3 and FORWARD-4 studies.
The two studies combined will incorporate sophisticated design features to ensure rigorous patient selection, monitoring and evaluation.
Data from these two studies are expected in 2016, while FORWARD-5, the third core efficacy trial, is expected to be started in mid 2014.
ALKS 5461 is designed to modulate the opioid system in the brain, employing a balanced combination of agonist and antagonist components that act on opioid receptors. It also includes a novel opioid modulator, samidorphan (ALKS 33), discovered by Alkermes.
Image: lkermes two Phase III studies FORWARD-3 and FORWARD-4 combined are expected to randomize about 1,000 MDD patients with ALKS 5461.Photo: courtesy of Keerati/ freedigitalphotos.net