Imagine medicating with a click on an index finger, a deep inhale, and holding that breath — only to exhale and leave no traces of scent behind.
This medication method could be a reality if the powder and inhaler combination passes the Food and Drug Administration’s Phase 1b clinical trial as it tests the efficacy and safety of the product. (Both the compound and the company’s inhaler are components of an inhaled insulin product that the FDA reportedly already approves.)
The product is called RLS103: It’s an inhalation powder containing “synthetic CBD and FDKP, an FDA-approved inhalation excipient,” states the company’s website. “In an initial proof-of-concept pharmacokinetic clinical study, RLS103 provided immediate CBD absorption with peak concentration less than 4 minutes after inhalation.”
In other words, “they are looking at the bio-availability of the [synthetic] CBD and how it ingests or absorbs into the body,” explained David Fowler of the Marijuana Industry Trade Association (MITA) in Phoenix.
The FDA process, you would think, is similar to when they test the CBD-infused powder used in edibles, but it’s different, as an inhaler is included with the finished product.
However, Fowler, who co-founded MITA in 2015 and is the executive director of the Cannaval music festival happening on April 30 in Phoenix — gives the new concept of medicating via a therapeutic-oral agent — a green thumbs up.
“People, in general, would much rather inhale something over smoking and or having to eat something and wait for the results,” he continued. “So I would imagine it would impact the market, especially when this method of delivery gets into the market.”
The contending product “has the potential to be the first-in-class treatment for acute anxiety disorders,” said Receptor Life Sciences CEO and president Mark Theeuwes in a statement. He added the data would hopefully guide future studies for other neurological and psychiatric disorders.
Last month, the Seattle-based pharmaceutical company raised $9.7 million to advance the cannabidiol-based therapeutic candidate for acute anxiety through clinical tests. This process wasn’t their first time, as they’ve developed therapies for “central nervous system disorders using FDA-approved drug-delivery technologies” in the past.
If approved, the new concept of medicating might cut into the edible CBD market.
“Edibles tend to take much longer to be effective and are much more challenging to regulate dosage,” Fowler continued. “People’s bodies tend to ingest and absorb CBD or any other compound for that matter, differently. So while inhaling, the compounds go directly into the lungs and into the bloodstream at a much high bioavailability rate, kind of the same way smoking versus eating an edible, you instantly feel the effects of the product.”
