Generalized Anxiety Disorder (GAD)

October 17, 2016

Bionomics issued results of a single-center, double-blinded, placebo and lorazepam-controlled, four-way, cross-over, phase II clinical trial of BNC210 conducted in 24 patients with untreated generalized anxiety disorder (GAD). The objective of the study was to evaluate the capacity of BNC210 to engage brain systems relevant to anxiety while resting and in response to anxiety-related tasks. The co-primary endpoints were a change in cerebral perfusion measured by arterial spin labelling and a change in task-related brain activity, specifically in the amygdala as measured by functional Magnetic Resonance Imaging (fMRI) during the Emotional Faces Task (EFT). The results of the study show that BNC210 induced statistically significant changes in cerebral perfusion (300mg BNC210, p<0.05) and also significantly reduced amygdala activation in response to fearful faces during the EFT (300mg BNC210, p<0.05). In comparison, lorazepam exerted a modest suppressive effect on amygdala activation during performance of the EFT (1.5mg lorazepam, p=0.069). A secondary endpoint of the trial was to determine the effect of BNC210 on defensive behaviour using the Joystick Operated Runway Task (JORT) which uses a force-sensing interface to obtain an objective measure of the intensity of threat avoidance motivation. BNC210 administration was associated with a significant decrease in the intensity of threat avoidance behaviour (300mg BNC210, p=0.007; 2,000mg BNC210, p=0.033). BNC210 outperformed lorazepam in this regard (1.5mg lorazepam, p=0.165).

January 14, 2008

Addex issued negative results from a phase IIa trial of ADX10059 for the treatment of acute anticipatory anxiety. This double-blind, placebo-controlled trial enrolled fifty subjects in the United Kingdom. All subjects were undergoing a routine dental procedure and presented with moderately severe anxiety. The subjects received a single 250 mg dose of ADX10059 or placebo sixty minutes prior to the procedure. The primary endpoint was a reduction on the Visual Analog Scale of anxiety (VAS anxiety) sixty minutes after dosing (immediately prior to the start of the dental procedure). Anxiety was measured at specific time points before, during and after the procedure. The results did not show a statistical difference between ADX10059 and placebo (mean VAS 4.81 cm compared to 4.67 cm, respectively). Based on the results, Addex did not announce plans to move forward with ADX10059 for this indication.

August 22, 2005

Predix reported positive results of a phase II trial of PRX-00023, their investigational 5-HT1A agonist, for the treatment of generalized anxiety disorder (GAD). Results demonstrated a positive overall safety profile, with no serious adverse events or drug related adverse events leading to discontinuation. The most common overall adverse event was flu-like symptoms. Secondary efficacy data produced preliminary improvements on the HAM-A, CGI-Global Improvement, and Hospital Anxiety and Depression diagnostic scales. This open-label, multi-center study enrolled 20 patients with moderate-to-severe GAD, who received sequential ascending dose regimens of the drug after a 1 week placebo run-in: subjects received 40 mg once daily for 4 days, then 80 mg once daily for 10 days, then 120 mg once daily for 14 days.

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