1. FDA WORLD FIRST The FDA has approved only one plant derived drug, Epidiolex for severe epilepsy and it achieved approximately USD$510 million in annual sales within two years of launch.
In addition, the FDA has also approved 3 synthetic cannabis drugs, Marinol (dronabinol), Syndros (liquid dronabinol) and Cesamet (nabilone) for nausea caused by chemotherapy or to help boost appetite for people with AIDS.
Currently there is no FDA approved cannabis nor synthetic cannabis solution for any kind of pain indication.
Neither has any medical cannabis inhaler received FDA approval.
Even the two biggest names in medical cannabis inhalation, Storz & Bickel (Canopy Growth) and Syqe (PMI), have not been FDA approved and may never will because they require heating.
This means IRX 211’s inhaled dronabinol solution via a pressurized metered-dose inhaler (pMDI) is in pursuit of the world’s first FDA approved medical cannabis drug-device for pain.
To achieve FDA approval, IRX needs to demonstrate with scientific data that IRX 211 is safe and effective.Metered dose inhalers have been used in human medicine since 1956. As a fast remedy for asthma, they are widely known and trusted.
2. KNOWN SAFETY
In regards to safety, dronabinol is already FDA approved for oral use with a 40 year plus history – its safety profile and side effects are well known.
Moreover, inhaled THC has a safety history spanning thousands of years with millions of people in non-clinical environments.
By contrast, smoking and vaporizers require heating and may contain impurities like irritants, additives, and extra fillers. Medical cannabis via a pMDI ensures the purest ingredients enter into the bloodstream.
IRX should have little trouble recruiting trial participants who will be paid to get high with a known drug in a known non-heated device.Upon FDA approval comes 3 years exclusivity from the FDA. According to the FDA’s own website “Patents and exclusivity work in a similar fashion.”
New drugs may not be legally introduced into interstate commerce in America without prior approval from the FDA unless they are over-the-counter (OTC) drugs lawfully marketed under section 505G of the FD&C Act.3. FDA FAST TRACK
In addition, if approved, it may be possible to leverage the data to open up IRX 211 for other pain indications, including complex regional pain syndrome (CRPS), which can receive 7 years FDA exclusivity as an orphan drug.
The 505(B)(2) pathway can see drug approval obtained in as little as 3 to 5 years vs 10 years plus otherwise.Because dronabinol is synthetic THC, it allows for mass manufacturing & batch consistency. This means what’s written on the label is what’s in the product to meet the high standards the FDA demands.
Essentially, the 505(b)(2) pathway allows the company to avoid unnecessary duplication of studies already performed on a previously approved drug.
IRX shareholders can benefit as 505(b)(2) results in a lower overall cost of development and faster route to marketing approval. Importantly, this pathway does not prevent IRX from obtaining Fast Track designation from the FDA to shave off even more time.
Fast track is a process designed to facilitate the development and expedite the review of drugs. The purpose is to get important new drugs to the patient earlier.
If there are already available therapies, a Fast Track drug must show some advantage over available therapy, such as avoiding serious side effects of an available therapy, which clearly IRX 211 aims to do.
A drug that receives Fast Track designation is eligible for more frequent meetings with FDA and more frequent written communication from FDA. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
Fast Track | FDA
4. SYNTHETIC THC
By contrast, the strength of plant derived medical cannabis can differ quite a bit making it very challenging to receive FDA approval. It lacks the precision of pharmaceutical medicine.It is very possible the use of cannabis as an adjunct therapy could result in a reduction in opioid dosage and consequently fewer undesirable side effects, including a decrease in opioid-related deaths and reduce the overall burden on the health care system.
Marcel Bonn-Miller, PhD, from the University of Pennsylvania Perelman School of Medicine said, "We did a study last year. Few of the products contained anywhere near what they said they did. That's a problem."
How Medical Marijuana Works, and Which Conditions It Treats (webmd.com)
Being human made also means there are zero issues caused by weather damage to crops and no extraction process required versus plant-based products.
Marinol vs. Cannabis: Everything You Need to Know - GoodRx
5. ETHICAL INVESTING
Now that IRX has selected breakthrough cancer pain (BTcP) as its pain indication, it presents companies, funds, and retail investors an attractive and powerful ethical narrative to ride as well as a substantial total addressable market (TAM).
The use of fast acting opioids is the cornerstone of controlling breakthrough pain episodes.
IRX 211, if successful, would be an alternative to fast acting opioids for BTcP.
Breakthrough pain negatively affects daily living in 80% of the patients with cancer pain. The overall prevalence of breakthrough pain was reported to be 59.2%. It was lower in outpatients (39.9%) and higher in hospice patients (80.5%). Episodes of BTcP have been reported to occur two or three times a day.
Breakthrough pain and rapid-onset opioids in patients with cancer pain: a narrative review (e-jyms.org)
A shocking population of Americans and Canadians succumb to opioid addiction daily and overdoses can often be fatal. Millions have already died from the opioid epidemic and it remains a grave public health concern in North America.
As a result, there is pressure on the FDA to find alternatives to opioid and cannabis is emerging as one possible option.
6. REDUCED OPIOID USUAGE
2 review articles evaluating 2,000 patients found that cannabis had significant pain-relieving effects. What’s more promising is that cannabis can help people take less opioids.
In some states where cannabis is legal, prescriptions for opioids fell and researchers found a link to fewer overdose deaths. A study from 2020 looked at adults who were reliant on opioids for chronic pain. When the participants took cannabis, half were able to stop all opioids and one third cut back on opioid use.
This is backed up by other studies which have shown that cannabis allows people to lower their opioid use by 40-60%.
Cannabis vs. Opioids for Chronic Pain - GoodRx
7. SYNERGIES WITH OPIOIDS
There is also growing evidence of the positive synergies when low-dose THC is added to chronic pain treatment with opioids; people have better pain control and there’s less risk of opioid related harm.
In another study, people taking both cannabis and opioids experienced fewer side effects and a better quality of life.
One search for a better analgesic strategy led to the discovery that delta 9-tetrahydrocannabinol (THC) enhances the potency of opioids such as morphine in animal models. In addition, studies have determined that the analgesic effect of THC indicates an intimate connection between cannabinoid and opioid signaling pathways in the modulation of pain perception.
Synergistic interactions between cannabinoid and opioid analgesics - PubMed (nih.gov)
Opioids and cannabinoids interactions: involvement in pain management - PubMed (nih.gov)
As such, cannabis could be an adjunct therapy for opioid addiction due to its safety and efficacy in managing opioid addiction. In essence, cannabis suppresses cravings induced by opiates and controls opioid withdrawal syndromes.
The Benefits and Effects of Using Marijuana as a Pain Agent to Treat Opioid Addiction | Insight Medical Publishing (imedpub.com)
8. FAST ACTINGDronabinol is so far only being orally consumed via a pill or in liquid form. It generally receives very favorable reviews, but it has one weakness. It takes a long time to work - about 30 minutes to 1 hour for effects to show up and the peak effects happen around 2 to 4 hours after you take it.
Breakthrough incident pain usually peaks in 5 minutes and is moderate-to-severe. If untreated, breakthrough pain lasts for a median of 45 minutes.
Consequently, dronabinol is unsuitable when consumed orally for patients with acute pain who need immediate remedy.9. PRECISION DOSAGE
In comparison, inhalation has a much more rapid onset of effect because the active ingredients enter the bloodstream through the alveoli in the lungs relatively quickly.
The effects of inhaling medical cannabis are usually felt within minutes and it produces on average a peak effect in less than 5 minutes as we can observe from Syqe’s thermal bong study.
The pharmacokinetics, efficacy, and safety of a novel selective‐dose cannabis inhaler in patients with chronic pain: A randomized, double‐blinded, placebo‐controlled trial - PMC (nih.gov)
This is actually at least 7 to 10 minutes faster than even the most rapid of the fast-acting opioids (fentanyl nasal sprays), which have an onset of action of between 5 to 10 minutes, but don’t reach peak effect until 12 to 15 minutes and around 20 minutes respectively.
For patients experiencing BTcP, fast acting opioids have an inconvenient time lag that leaves patients in a state of pain until the effects kick in. On the other hand, inhaled medical cannabis delivers a timely solution that kicks in within minutes and reaches its peak effect before the patient’s BTcP reaches its peak. Therefore, inhalation offers a clear-cut time advantage over orally administered dronabinol and even highly addictive opioids.
Another unpredictability linked to the oral administration of cannabinoids is that inexperienced patients won’t notice the effect of the initial administration right away and might increase the dose too early.
A pMDI is an inhaler device that provides a precisely measured dose of the active agent in each puff. You don’t have to bother with measuring doses, preparation, or any other confusing processes. When the stem on the pMDI canister is depressed, a finite amount of drug is released at a certain velocity and a spray cloud develops.
The advantage of pMDIs is the accurate and repeatable dosing, which minimizes errors. Not only is the drug fast acting, there is no guesswork unlike smoking or vaping.
10. PRACTICALITY
pMDI’s are small and lightweight, so you can easily put an inhaler in a handbag or pocket. Most importantly, they do not produce any odor or smoke, which ensures discrete usage without leaving any traces or secondhand smoke behind. This feature differentiates it from other fast acting consumption methods (vaping and smoking), where users are severely restricted in the places where they can smoke. In stark contrast, inhalers are discreet and can be used anywhere in public, including at work, restaurants, or on public transport.
11. ALIGNED MANAGEMENT
IRX’s management is a small and nimble team with skin in the game. CEO Darryl Davies and Dr Sud’s Cannvalate own 19%. It’s a lean, low-cost operation by any standard, but especially compared to many ASX cowboy run small cap P&D companies. They don’t waste money and there are no lifestyle wages. The 3 directors' combined total wages are $166,650 excluding superannuation. That’s less than individual directors at some small cap companies are getting paid.
The CEO is on $135,000 while the CSO, Dr Jenny, is on $108,000. Key management including the Chair, CEO, and CSO have also aligned themselves with shareholders by setting their options at 15 cents & 20 cents.
12. RISK VS REWARD
POTENTIAL TRIGGERS
The first one that comes to mind is there will likely be a major rerate if company secures on reasonable terms a strategic investor onboard for the journey and not a low-ball pump and dump raise for the moment.
This is a wait and see, however, the company regularly and comfortably informs the market that a capital raise is required to start the phase 2, which is refreshingly honest and suggests the company is looking for the former and not the latter.
The second is obviously contingent on the above, and that is positive updates from the phase 2 trial. At the current market capital and low SOI, the share price could easily fly on positive outcome trial news.
A third is if the company were to announce news of patent protection over the process and/or inhaler. PMI has already snapped up one company which obtained a patent on inhaled aspirin for over a half a billion USD$.
Media - Press Details | PMI - Philip Morris International
IRX has informed shareholders it has filed a patent for breakthrough cancer pain and there may yet be aspects of the device itself which can be patented.
CONCLUSION
IRX has attractive takeover potential if it can demonstrate in a phase 2 trial that it is a safe and effective opioid sparing solution for sufferers of BTcP.
Big Tobacco is investing "beyond nicotine" and looking for smoke free alternative markets including cannabinoids as the world rapidly moves away from cigarettes.
The holy grail for Big Tobacco is an FDA sanctioned inhaler for medical cannabis like Philip Morris scored with its simple Iqos device for inhaled nicotine.
Transforming beyond nicotine - Letter from the Chief Sustainability Officer | PMI - Philip Morris International
IRX has been positioned for a potential 4-way win/win.
Imho & Gltah
THE BUY CASE
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