BURLINGTON, ON – EmpowerPharm Inc. is delighted to announce that the final participant has completed their treatment in the Phase II clinical trial assessing the efficacy of pharmaceutical-grade Cannabidiol (CBD) for Social Anxiety Disorder. The anticipated release of the top-line results are due next month in April.
The trial, sponsored by EmpowerPharm, was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of CBD in individuals with Social Anxiety Disorder. It is the first study of its kind to be approved by the FDA.
This pivotal Phase II study involved the enrollment of 239 patients from 19 clinical centers across the United States.
The research team at EmpowerPharm has developed a novel, patented drug delivery platform using a Self-Nanoemulsifying Drug Delivery System (SNEDDS), which ensures superior bioavailability, consistent potency, extended shelf-life, and stability. This platform has potential applications for enhancing legacy drug molecules.
“Coincidentally, the first product developed using the SNEDDS technology is a prescription cannabidiol (CBD) pill, which is poised to become the first pharmaceutical-grade prescription drug of its kind approved for the treatment of anxiety,” said Chairman and Co-CEO, Aubrey Dan. “Over the last two decades, there has been a notable lack of innovation in the development of new medications for anxiety. There’s an urgent demand for novel drugs that can offer effective relief without the adverse side effects and addictive potential of current prescriptions.”
After the report of Phase II Clinical Trials is complete and submitted in April, EmpowerPharm will move into Phase III clinical trials which will precede the FDA approvals process, marking anticipated availability to patients by 2028.
“Our vision was to develop top-quality prescription pharmaceuticals to meet unmet needs. With over 15 million adults suffering from Social Anxiety Disorder in the United States, our mission is unequivocally clear,” said Peter Billiaert, President and Co-CEO.
EmpowerPharm is seeking strategeic partners to launch this breakthrough innovation. The market for Social Anxiety Disorder treatments was valued at $11.8 billion in 2022 and is expected to grow to $16 billion by 2030. EmpowerPharm anticipates that the introduction of the world’s first CBD-based prescription drug could result in annual sales between $160 million and $320 million USD. This innovation not only has the potential to disrupt the market for Social Anxiety Disorder, but also holds promise for other patient populations. Its impact on conditions such as depression and sleep quality could open up additional market opportunities exceeding $8 billion.
EmpowerPharm Inc. is led by Chairman and Co-CEO, Aubrey Dan, a seasoned pharmaceutical executive at Novopharm Limited with more than 20-years of industry experience, and EmpowerPharm President and co-CEO, Peter Billiaert. Billiaert is a veteran in the pharmaceutical industry with more than 40-years experience in R&D program management at Novopharm Limited and Teva Pharmaceuticals.
