Amarin boosted by depression trial data

In the exploratory clinical trial, Miraxion was used as adjunct therapy, with either selective serotonin reuptake inhibitors or tricyclics, in 115 patients with treatment-unresponsive depression.

Although in the whole group Miraxion did not show a significant difference over placebo, an exploratory analysis demonstrated significant superiority in the subgroup of depression patients with melancholic characteristics using a repeated measurements design.

This sub-group of depression patients was defined by using select criteria from DSM-IV, the main diagnostic reference of mental health professionals in the US. Identical methodology was used to identify melancholic depression patients in a previous data analysis from a 77-patient monotherapy trial and a 70-patient adjunct therapy depression trial.

The data from all three trials are consistent and show a significant clinical benefit using Miraxion in patients with depression with melancholic characteristics.

It is estimated that depressed patients who are unresponsive to standard treatment and have melancholic depression symptoms may represent approximately 20-30% of all patients with depression.

“The exploratory analyses from three phase IIa clinical trials have shown consistent positive data in the treatment of depressed patients with melancholic characteristics,” commented Rick Stewart, CEO of Amarin. “This positive data allows us to more accurately target patients with depression that may respond to Miraxion.”

Amarin is currently planning a larger confirmatory phase II clinical trial, as well as seeking a development and marketing partner for Miraxion in depression.