BURLINGTON, ON – EmpowerPharm Inc. is delighted to announce the outcome of their Phase 2 clinical trial assessing the dose finding, efficacy, safety, and tolerability of Cannabidiol (CBD) drug product for Social Anxiety Disorder (SAD). The results demonstrated efficacy for a subset of patients suffering from moderate to severe SAD. These results will guide further clinical research and the design of a robust Phase 3 program.
The trial, sponsored by EmpowerPharm® was managed by Syneos Health. The study enrolled 239 patients from 19 clinical centers across the United States, 178 patients completed the study. It was a randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of 300mg and 600mg daily dosing of CBD in patients with Social Anxiety Disorder. It is the first, well powered and appropriately designed clinical trial to demonstrate efficacy, safety, and tolerability of CBD for the treatment of patients with chronic SAD.
The trial provided information about the likely effective dose that we will carry forward into a Phase 3 trial for the treatment of patients with chronic social anxiety symptoms using the Liebowitz Social Anxiety Scale (LSAS) as a measure of efficacy. In addition, the study demonstrated a favorable safety profile and excellent tolerability of CBD in this patient population.
The Liebowitz Social Anxiety Scale is a widely used questionnaire designed to assess the severity of social anxiety disorder. It consists of two subscales: one measuring fear (of social and performance situations) and the other measuring avoidance (of social and performance situations). The LSAS is used by clinicians and researchers to evaluate the extent and impact of social anxiety symptoms in individuals.
Peter Billiaert, President & Co-CEO said “I would like to acknowledge the tireless efforts of the scientific team, collaborators, and study participants, emphasizing the demand for new social anxiety disorder treatments. Looking ahead, the results of the Phase 2 study will guide further clinical research and the design of a robust Phase 3 program to advance the treatment of Social Anxiety Disorder”. Billiaert continued, “EmpowerPharm® remains committed to providing safe and efficacious treatment alternatives for patients in need.”
EmpowerPharm® has developed innovative drug formulations in patent pending or application preparation stages based on the Self Nanoemulsifying Drug Delivery System (SNEDDS) technology platforms. These formulations have demonstrated enhanced bioavailability of CBD, as well as full compliance with International Council of Harmonization (ICH) Technical Requirements for Drugs for Human Use and an ICH compliant drug stability program confirming physical, chemical, and microbiological stability of the developed CBD drug dosage forms.
“This will be our first product developed using patent pending drug formulation based on SNEDDS (Self Nanoemulsifying Drug Delivery System) technology. It is a prescription cannabidiol pill, which is poised to become the first CBD prescription drug of its kind approved for the treatment of Social Anxiety Disorder. Cannabidiol is a psychoactive, but non-intoxicating compound derived from the cannabis plant. The pill does not contain any tetrahydrocannabinol (THC), the ingredient that causes intoxication.” said Chairperson and Co-CEO, Aubrey Dan.
Dan continued, “Recent data suggests a lull in new anxiolytic developments, emphasizing the need for safer, non-addictive alternatives. A survey of psychiatrists reveals that between 5 – 60% of their patients self-medicate with recreational cannabis. Access to a prescription CBD pill, supported by insurance and government aid, could improve treatment access.”
Murray Stein MD, MPH, FRCPC, Distinguished Professor of Psychiatry at the University of California, San Diego and a consultant to EmpowerPharm, notes that “There continues to be a pressing need for new treatments for patients with Social Anxiety Disorder. Many patients with SAD are already using cannabis products to relieve their symptoms, but the evidence that these drugs work is lacking. EmpowerPharm’s plans to conduct a definitive Phase 3 program to determine the efficacy of CBD will be closely watched by patients and prescribers alike.”
Social anxiety disorder is a mental health condition characterized by intense fear, anxiety, or embarrassment when faced with social situations. Treating the disorder can result in reduction of symptoms and improvement in functioning and quality of life. SAD affects approximately 15 million adults or 7.1% of the U.S. population. SAD is equally common among men and women and typically begins around age 13. According to an Anxiety and Depression Association of America (ADAA) survey, 36% of people with social anxiety disorder report experiencing symptoms for 10 or more years before seeking help. The Social Anxiety Treatment market was valued at USD $12B in 2022 and is projected to reach USD $16B by 2030, at a CAGR (Compound Annual Growth Rate) of 3.9% during the forecast period.
EmpowerPharm® is a life sciences pharmaceutical company founded in 2018, specializing in the development of cannabinoid-based prescription drug products. These products target therapeutic indications, where patients need safe and efficacious treatment alternatives to currently available therapeutic options. In addition, EmpowerPharm® specializes in the development of novel, solid oral dose formulations for challenging drug molecules with characteristics of low aqueous solubility, low bioavailability and high first pass metabolism.
EmpowerPharm® operates a state-of-the-art $30 million fully qualified manufacturing and research facility in Burlington, Ontario. The facility includes production and pharmaceutical R&D equipment that is qualified and maintained to GMP (Good Manufacturing Practice) standards, the required quality standards for the commercialization of pharmaceutical products. EmpowerPharm® is the first dedicated pharmaceutical company in Canada to have a manufacturing facility with a Drug Establishment Licence (DEL) that is built for cannabinoid-based prescription pharmaceuticals.
Forward Looking Statement
This press release contains forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those anticipated. Such risks and uncertainties include, but are not limited to, the potential impact of regulatory developments, market conditions, competitive factors, and technological advancements. It should be noted that any forward-looking statements made in this release are based on current expectations and assumptions as of the date of the release. EmpowerPharm Inc. undertakes no obligation to update or revise any forward-looking statements, whether because of added information, future events, or otherwise. Investors and stakeholders are cautioned not to place undue reliance on these forward-looking statements, as they are inherently subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in such statements. Investing in pharmaceutical products involves a high degree of risk, and investors should carefully consider all relevant factors before making any investment decisions. The company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events. It is advisable to consult with qualified professionals for guidance on investment decisions and for a thorough understanding of the risks associated with investing in pharmaceutical products. Pharmaceutical development is a complex and highly regulated industry, and caution should be exercised when assessing the potential outcomes and impacts of new medications on the market.
