FDA approves phase 2b/3 trial of adult ADHD treatment
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The FDA has granted approval to late-stage biotech company Neurocentria Inc. to conduct a pivotal phase 2b/3 human clinical trial of its drug candidate NRCT-101SR compared with inactive placebo among adults with ADHD.
Current ADHD treatments target monoamine synapses, whereas this drug candidate focuses on the novel target of glutamatergic synapses, according to a press release. Results of preclinical studies suggested NRCT-101 increases glutamatergic synaptic density, function and plasticity in the prefrontal cortex and hippocampus, which leads to improvements in cognitive function and emotional regulation.
“This is an exciting time for Neurocentria as we initiate a pivotal phase 2b/3 trial to test our novel therapy for adults with ADHD,” Guosong Liu, MD, PhD, founder and CEO of Neurocentria, said in the release. "We are confident our drug candidate will address a major unmet medical need for these people, which often leave them saddled with significant side effects and without improving their quality of life.
“Considering the significant side effects of current medications, the need is great for new drugs that will improve ADHD core symptoms, executive function, overall cognitive performance and mood status, with a good tolerability profile, allowing people in need to be treated,” Liu added.
The randomized, double-blind, placebo-controlled clinical trial builds on several prior human trials among younger and older adult populations. These trials showed an association between NRCT-101SR treatment and improved cognition and overall mood status, including reduced depression and anxiety symptoms. Safety data from more than 200 participants of several studies showed the treatment was well-tolerated and had an overall strong safety profile and fewer adverse events compared with placebo, which, if confirmed via further clinical studies, would offer a significant advantage compared with current ADHD treatments that are linked to significant side effects, according to the release.