Title: FDA Approves Trials of Inhaled CBD Drug for Social Anxiety Disorder (back of person sitting on a dock)

FDA Approves Trials of Inhaled CBD Drug for Social Anxiety Disorder

The first-of-its-kind drug/device combination shows promise as speedy solution for troublesome symptoms.

Zack Ruskin April 12, 2022

Not to be confused with the occasional bout of jitters, social anxiety disorder is very real. So real, in fact, that it currently affects a sizeable portion of the U.S. population. Today, there are as many as 15 million Americans living with this condition, which qualifies it as the nation’s second-most diagnosed anxiety disorder.

Despite its prevalence, the available options for quelling acute symptoms associated with social anxiety disorder have thus far remained largely limited and lacking. Compounded by the added stress of being in a public setting, symptoms like trembling, nausea, and difficulty speaking can become debilitating.  As a result, treatment options that can provide quick relief are understandably in high demand

Xanax, for example, is often prescribed as a fast-acting solution for panic attacks, but as a benzodiazepine, it still requires an average of 30 to 60 minutes to kick in — to say nothing of its proven issues as a habit-forming substance. For this reason, the arrival of a new alternative treatment carries with it the prospect of changing millions of lives for the better.

And in this case, the new drug isn’t another benzodiazepine or even a pill at all, but incredibly an inhaler equipped to dispense a dry powder form of CBD.

MEET THE INHALER THAT DISPENSES CBD

Breaking the mold on several fronts at once, Receptor Life Sciences’ application for the new drug delivery technology was approved last week by the FDA. Under this approval, Receptor Life Sciences can now initiate Phase 1B clinical safety trials, which will go on to inform “the design of a larger, well-controlled, randomized Phase 2/3 safety and efficacy study intended for registration,” per Benzinga.

The appeal behind this first-in-class drug/device combination – designated by the FDA as application RLS103 — lies in the improvement in purportedly offers over more commonly available oral CBD solutions. In findings published in the Journal of Pharmaceutical Sciences, Receptor Life Sciences shared that by pivoting from an oral CBD solution to a dry powder dispensed via an inhaler, CBD bioavailability can increase dramatically.

Title: FDA Approves Trials of Inhaled CBD Drug for Social Anxiety Disorder (Glove holding inhaler)

Overall, RLS103 had 9-fold higher bioavailability In comparison to oral CBD, with peak concentrations following inhalation measuring a whopping 71-fold higher.

Additionally, a proof-of-concept pharmacokinetic clinical study found that RLS103 could provide “immediate CBD absorption with peak concentration less than 4 minutes after inhalation.” Thus, an inhaler dispensing dry CBD powder — in this case, a synthetic form of the cannabinoid paired with an FDA-approved inhalation excipient called FDKP — offers appealing improvements in the areas of both dosage efficacy and relief expediency for patients.

In a statement, Receptor Life Sciences CEO Mark Theeuwes highlighted the impact RLS103 stands to make for the many social anxiety disorder patients currently seeking fast relief for major symptoms:

“No currently available therapies address the challenge of providing immediate relief for patients living with social anxiety. This [FDA approval] allows us to test RLS103 in a number of clinical proof-of-concept safety and efficacy studies. The results will guide continued development in indications that show the most promise. RLS103 has the potential to be the first-in-class treatment for acute anxiety disorders.”

Bad News for Bongs

The revelation that inhaled CBD — in powder form or otherwise — provides increased efficacy over its oral equivalent also arrives as a new study has concluded that inhaling secondhand smoke from bongs does more damage to humans than secondhand tobacco smoke.

In findings published to the Jama Open Network last week, researchers from the University of California, Berkeley revealed that secondhand bong smoke contains fine particulate matter in much higher concentrations than secondhand tobacco smoke, thus making it more dangerous.

Using cannabis-consuming students in attendance at the university as their subjects, researchers “measured levels of fine particulate matter before, during and after eight cannabis social-smoking sessions in the living room of an apartment near campus,” reports The Guardian. The outlet also detailed that all subjects were responsible for providing their own cannabis and bongs, remained anonymous, and “were not observed during the two-hour smoke sessions.”

The results: fine particulate matter from cannabis bong smoke was found to be at least four times greater than that from the smoke produced by tobacco.

Though this study still leaves plenty of room for improvement (controlling the baseline quality of the cannabis used, for instance), it does bode well for the popularity of non-combustible cannabis products. Based on what they’ve shown so far, that positions Receptor Life at the forefront of what could become a new, larger inhaled powder trend in the industry.


Zack Ruskin

Zack Ruskin is a freelance reporter living in San Francisco. His bylines include Vanity Fair, Rolling Stone, Leafly, San Francisco Chronicle, Variety, Billboard, Cannabis Now, and California Leaf.