Very recently we’ve seen news start to roll on one of InhaleRx’ potential twin turbos, IRX 211. It may be worth a deeper dive here to get some discussion going.
Dronabinol vs THC It’s important to note from the get-go that IRX 211 does not contain medical cannabis. The distinction is of upmost importance.
IRX 211's active ingredient is dronabinol, a lab made synthetic form of THC, one part of the medical cannabis plant and notably the part that triggers the high.
This is advantageous for a number of reasons:
Firstly, dronabinol is off-patent and FDA approved (1985) in oral form but not yet for pain indication. Secondly, because it is lab made it has a consistency of "high" which is unlikely with THC derived directly from the plant.
Inhalation vs Oral Delivery Currently, because dronabinol is taken orally, there is quite a time lag for the “high” effect to kick in. In short, this makes oral consumption useless for pain indication which needs a fast acting remedy.
By contrast, inhalation is almost instantaneous and you get much more absorption bang for your buck, so a lesser dosage is required.
While there are pressurized metered-dose inhalers (PMDI) available with FDA unapproved THC from the plant, there appears to be a gap in the market for an FDA approved dronabinol PMDI for pain indication.
There is evidence a few companies have tried, most notably Senzer, where curiously current InhaleRx director Dr Andrew Saich worked after GW Pharma.
This is probably a coincidence, however, as Senzer was a highly technologically advanced inhaler with hundreds of patents and there is no evidence (or announcement) of InhaleRx owning a PMDI patent. Even so, Dr Saich’s skillset and experience at both GW Pharma and Senzer won’t hurt at all here.
PATENTS Speaking of patents, it was highly surprising to see that IRX 211 does not purport to mix dronabinol with another drug.
Based on IHL’s past success of combining two off patent drugs to form a new patentable drug, it was logical to assume IRX 211 would follow suit. It hasn’t.
Darryl informed holders at the AGM that IRX does have a number of patents in the works but is holding back for strategic reasons; so essentially we’re still in the dark here. There may be a special patentable sauce in the inhaler mist but this is a wait and see.
THE FDA TWIST We’ve also been informed the FDA has suggested to IRX to consider an alternative pain indication instead of Complex Regional Pain Syndrome (CRPS). Today’s announcement may have shone a light on what this twist may be: breakthrough pain.
Breakthrough pain is defined as abrupt pain that flares up and breaks through baseline pain for patients already taking pain control medications. It’s most common for people with cancer but extends to arthritis and multiple sclerosis.
Breakthrough pain is treated with opioids, including morphine, oxycodone and fentanyl.
Obviously, this would be a much larger market than CRPS and seems to indicate the FDA’s preference is to find an alternative to opioids for breakthrough pain over CRPS.
From the article ‘Fentanyl and the US Opioid Epidemic’ we may glean why:
‘The opioid epidemic is wreaking havoc on the U.S. economy. In 2022, the U.S. Congress Joint Economic Committee (JEC) found that the opioid epidemic cost the United States nearly $1.5 trillion in 2020, or 7 percent of gross domestic product (GDP), an increase of about one-third since the cost was last measured in 2017. The JEC projected this increase would continue given the rise in fatal overdoses.’
BIG PHARMA There are already early hints from CEO Darryl that the likely aim is for Big Pharma to buyout IRX if the phase 2 trials are successful. If so, what’s in it for big pharma?
From a public image point of view, the answer is quite a lot. A fast-acting, non-addictive alternative to opioids for breakthrough pain for one thing. Plus, there’s also the dollar side of things. A precise and consistent small, lightweight disposable inhaled dronabinol solution competes directly with smoking medical cannabis at a cost-effective price (lower than vaporizers). Especially, it should have broader appeal to the seemingly ever-growing non-smoker market and any medicinal cannabis smoker needing immediate relief in public, including restaurants and airplanes.
For the very first time this company is delivering on its stated goals and while it’s still early days, most importantly the company thinks big and has the personnel to accomplish big things. The current market capital hasn’t baked any of this potential into the cake.
Imho and GLTAH
IRX Price at posting:
4.5¢ Sentiment: Buy Disclosure: Held
