EmpowerPharm's Innovative CBD for Social Anxiety Disorder Awaits Phase II Results

EmpowerPharm Inc. has announced the successful completion of its Phase II clinical trial for the treatment of Social Anxiety Disorder using pharmaceutical-grade Cannabidiol (CBD). The final participant concluded their treatment, and the main results are expected to be released in April.

Sponsored by EmpowerPharm, the clinical trial was a thorough, multicenter, and placebo-controlled study. It employed a randomized, double-blind, parallel-group format to thoroughly evaluate the effectiveness, safety, and tolerability of CBD in treating Social Anxiety Disorder. This is the first CBD study of its kind to receive FDA approval.

The trial enrolled 239 patients across 19 clinical centers in the United States. EmpowerPharm's research team has created a novel drug delivery platform named the Self-Nanoemulsifying Drug Delivery System (SNEDDS). This patented system ensures higher bioavailability and consistent potency, as well as extended shelf-life and stability. It has the potential to enhance the delivery of various legacy drug molecules.

The first product developed using the SNEDDS technology is a prescription CBD pill. EmpowerPharm is optimistic that this product will become the first FDA-approved prescription drug specifically for anxiety treatment. According to Chairman and Co-CEO Aubrey Dan, the last two decades have seen little innovation in anxiety medications, leading to an urgent need for new drugs that provide effective relief without side effects or addiction potential.

Following the completion and submission of the Phase II trial report in April, EmpowerPharm plans to advance to Phase III clinical trials. This is a significant step towards obtaining FDA approval, with the goal of making the drug available to patients by 2028.

Peter Billiaert, President and Co-CEO, highlighted the company's commitment to developing high-quality prescription pharmaceuticals that address unmet needs. With over 15 million adults in the U.S. suffering from Social Anxiety Disorder, EmpowerPharm's mission is to provide effective treatment options.

The market for Social Anxiety Disorder treatments was worth $11.8 billion in 2022 and is anticipated to grow to $16 billion by 2030. EmpowerPharm predicts that their CBD-based drug could achieve annual sales between $160 million and $320 million USD.

EmpowerPharm's innovation also holds promise for treating other conditions, such as depression and sleep disorders, potentially opening up additional market opportunities exceeding $8 billion.

EmpowerPharm Inc. is led by Aubrey Dan, a Chairman and Co-CEO with over two decades of experience at Novopharm Limited, and President and Co-CEO Peter Billiaert, who has 40 years of experience in research and development program management at Novopharm Limited and Teva Pharmaceuticals.