Canadian pharmaceutical company EmpowerPharm has finished treating the final participant in the Phase II clinical trial of pharmaceutical-grade cannabidiol (CBD) for the treatment of social anxiety disorder.

The trial is claimed to be the first of its kind to receive approval from the US Food and Drug Administration (FDA).

EmpowerPharm is sponsoring the randomised, placebo-controlled trial, which aims to assess the efficacy, safety and tolerability of CBD in people with social anxiety disorder.

A total of 239 subjects have been enrolled at 19 clinical sites across the US, with top-line results from the trial expected to be released next month.

EmpowerPharm president and co-CEO Peter Billiaert said: “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.”

Once EmpowerPharm has completed and submitted the Phase II clinical trial report in April, the company plans to advance to Phase III clinical trials.

This next phase will precede the FDA approval process, with the drug anticipated to be available to patients by 2028.

EmpowerPharm estimates that the world’s first CBD-based prescription drug could generate annual sales of between $160m and $320m.

In addition to social anxiety disorder, the drug could have the potential to treat conditions such as depression and sleep quality, creating additional market opportunities of more than $8bn.

EmpowerPharm chairman and co-CEO Aubrey Dan said: “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.”

In May 2022, EmpowerPharm received clearance for an investigational new drug (IND) application from the FDA to begin the Phase II clinical study of cannabidiol.