EmpowerPharm Finishes Phase II Trial on Potential CBD Treatment for Social Anxiety Disorder
The trial of a pharmaceutical-grade CBD for social anxiety disorder, which was the first of its kind to be approved by the FDA, is expected to receive top line results next month.
EmpowerPharm, Inc. has announced the completion of a Phase II trial focused on measuring the effects of pharmaceutical-grade CBD for social anxiety disorder (SAD). The study, which is the first of its type to receive a green light by the FDA, involved 239 patients across 19 clinical centers in the United States. Results are expected to be released to the public sometime next month.
In order to conduct the trial, EmpowerPharm relied on the Self-Nanoemulsifying Drug Delivery System (SNEDDS), a drug delivery platform aimed at providing superior bioavailability and stability. According to the company, this is the first potential drug that utilized the platform, setting out to provide a potential solution to the need for creative anxiety medications without adverse effects.1
"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 Aubrey Dan, chairman, co-CEO, EmpowerPharm, in a press release. "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."
According to data from the Anxiety & Depression Association of America, SAD affects 15 million adults in the United States, equaling approximately 7.1% of the population. Additionally, the condition begins surfacing in both men and women around the age of 13 years, with 36% of those with the disorder first experiencing symptoms close to 10 years before deciding to find treatment.2
Other statistics include:
- Over 75% of people with SAD experience their first symptoms during childhood or early teen years, as previously alluded to.
- Current treatments include antidepressants, benzodiazepines, and beta-blockers in combination with cognitive-behavioral therapy (CBT).3
Pending results of the Phase II trial, EmpowerPharm intends to proceed to Phase III trials, with the end goal of receiving an FDA approval. From there, the company is hoping to have a final product on the market by 2028. With this goal, the company speculates that the CBD market has the potential to grow to $16 billion by 2030, including annual sales between $160 million and $320 million. It also hopes to generate additional revenue from potentially treating conditions such as depression and sleep disorders.1
"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, co-CEO, EmpowerPharm, in the press release.
References
1. EMPOWERPHARM AWAITS PHASE II CLINICAL TRIAL ON GROUNDBREAKING TREATMENT TO MANAGE SOCIAL ANXIETY DISORDER. PR Newswire. March 11, 2024. Accessed March 11, 2024. https://prnmedia.prnewswire.com/news-releases/empowerpharm-awaits-phase-ii-clinical-trial-on-groundbreaking-treatment-to-manage-social-anxiety-disorder-864172140.html
2. Anxiety Disorders - Facts & Statistics. ADAA. Accessed March 11, 2024. https://adaa.org/understanding-anxiety/facts-statistics
3. Social Anxiety Disorder. MHA. Accessed March 11, 2024. https://mhanational.org/conditions/social-anxiety-disorder
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