Phase II Depression Study Begins with First Dose

Dr. Vince Clinical Research (DVCR), a leading contract research organization (CRO), has initiated a Phase II clinical trial for SPN-820, a novel antidepressant medication, targeting adults suffering from major depressive disorder (MDD). The condition is prevalent, impacting over 17 million adults in the United States, with a significant proportion showing resistance to conventional treatments.

Developed by Supernus Pharmaceuticals in partnership with Navitor Pharmaceuticals, SPN-820 is designed to offer a swift antidepressant impact through oral intake. The drug's innovative mechanism boosts synaptic function and brain cell metabolism, with clinical trials indicating a rapid effect onset within two hours. SPN-820 is unique in its aim to deliver quick relief without the neurological and dissociative side effects associated with other rapid-acting antidepressants.

Supernus Pharmaceuticals' Chief Medical Officer, Dr. Jonathan Rubin, highlighted the significance of the study, emphasizing the drug's potential for rapid effect and infrequent dosing, which is every three days. He also expressed gratitude for the collaboration with DVCR in advancing the SPN-820 program.

The Phase II trial, set to enroll around 50 MDD patients, is being conducted across six U.S. locations. The primary goal is to assess the drug's efficacy and safety over a seven-day period with once-every-three-day dosing. The study will collect cognitive scale data for primary and secondary outcomes, alongside multiple pharmacokinetic assessments during extended visits.

Brad Vince, DO, CEO and Medical Director of DVCR, expressed enthusiasm for contributing to the development of more effective depression treatments and the organization's strategic expansion in this field. He also noted the importance of partnerships beyond clinical pharmacology studies.

Korey Nevitt, DVCR's Executive Director of Site Partnerships, praised the collaborative effort and transparent communication that led to the trial's milestone. He credited the proactive and responsive nature of the study sites and Supernus' clinical development team for the swift progress.

DVCR anticipates the successful completion of the trial and remains committed to providing its specialized solutions to the biopharmaceutical sector.

DVCR is renowned for its state-of-the-art facilities in Overland Park, Kansas, featuring a 90-bed clinical pharmacology unit and a GMP-compliant pharmacy. The organization is dedicated to conducting early-phase trials for both healthy volunteers and patient groups, leveraging advanced technology and a seasoned leadership team to deliver Smarter, Faster Data® to clients.