EmpowerPharm Inc. Announces Phase 2 Trial Results for CBD Drug in Social Anxiety Disorder

EmpowerPharm Inc., headquartered in Burlington, Ontario, recently announced the successful outcome of their Phase 2 clinical trial evaluating Cannabidiol (CBD) as a treatment for Social Anxiety Disorder (SAD). This trial marks a significant milestone for patients burdened with moderate to severe SAD, as the results showed promising efficacy and safety profiles for the CBD treatment.

Conducted under the sponsorship of EmpowerPharm® and managed by Syneos Health, the trial enrolled 239 patients from 19 clinical centers across the United States. Out of these, 178 patients completed the study. The trial's design was rigorous: a randomized, double-blind, parallel-group, placebo-controlled study that assessed the efficacy, safety, and tolerability of daily doses of 300mg and 600mg of CBD for patients with chronic SAD. Notably, this trial is the first of its kind to provide well-powered, robust evidence supporting the use of CBD for SAD treatment.

The study utilized the Liebowitz Social Anxiety Scale (LSAS) to measure the effectiveness of the CBD doses. LSAS is a well-regarded questionnaire that evaluates the severity of social anxiety symptoms through its subscales measuring fear and avoidance in social and performance situations. The trial demonstrated a favorable safety profile and excellent tolerability for CBD in the patient population, which will inform the design of future Phase 3 trials.

Peter Billiaert, EmpowerPharm's President & Co-CEO, expressed gratitude to the scientific team, collaborators, and study participants. He highlighted the pressing need for new treatments for SAD and emphasized that the Phase 2 study findings would guide further clinical research and the development of a robust Phase 3 program. EmpowerPharm® is committed to pioneering safe and effective treatment alternatives for patients in need.

The company has developed advanced drug formulations using Self Nanoemulsifying Drug Delivery System (SNEDDS) technology platforms. These formulations have shown enhanced bioavailability of CBD and full compliance with International Council of Harmonization (ICH) Technical Requirements, confirming the stability of the developed CBD drug dosage forms.

Aubrey Dan, Chairperson and Co-CEO of EmpowerPharm, revealed that the CBD prescription pill in development does not contain tetrahydrocannabinol (THC), the intoxicating component of cannabis. This pill, based on SNEDDS technology, is anticipated to be the first approved CBD prescription drug for SAD treatment. Dan pointed out the stagnation in new anxiolytic developments and underscored the need for safer, non-addictive alternatives. Access to a prescription CBD pill could improve treatment accessibility, supported by insurance and government aid.

Murray Stein MD, MPH, FRCPC, a Distinguished Professor of Psychiatry at the University of California, San Diego, and a consultant to EmpowerPharm, emphasized the ongoing need for new SAD treatments. He noted that many SAD patients self-medicate with cannabis products, although the efficacy of these treatments lacks scientific backing. Therefore, EmpowerPharm's planned Phase 3 program to establish the efficacy of CBD will be closely monitored by both patients and prescribers.

Social Anxiety Disorder is characterized by intense fear and anxiety in social situations, affecting approximately 15 million adults in the U.S. or 7.1% of the population. The disorder often begins around age 13 and affects men and women equally. According to the Anxiety and Depression Association of America, 36% of individuals with SAD experience symptoms for a decade or more before seeking help. The Social Anxiety Treatment market, valued at USD $12 billion in 2022, is projected to grow to USD $16 billion by 2030.

EmpowerPharm®, founded in 2018, specializes in developing cannabinoid-based prescription drugs. The company operates a state-of-the-art $30 million manufacturing and research facility in Burlington, Ontario, meeting Good Manufacturing Practice (GMP) standards and holding a Drug Establishment Licence for cannabinoid-based pharmaceuticals.

The company's progress reflects its dedication to pioneering innovative treatments for patients suffering from debilitating social anxiety, promising a significant impact on the well-being and quality of life for those affected by SAD.