IRX 211 & the Giant Market Gap in BTcP

The company's flagship product IRX 211 is a rapid acting opioid alternative delivered by a pMDI for breakthrough cancer pain (BTcP).

The phase 1 has already demonstrated its safety profile, and now we await the phase 2 trial news, which is due to start next quarter - potentially within days or weeks.

Currently, over 18 million Americans are suffering from cancer. BTcP is stated to affect 40%-70% of cancer sufferers, so it is estimated between 7 to 10 million Americans could be on some kind of BTcP prescription.

The TAM is conservatively USD $1 billion plus and potentially much closer to 2 billion. Indeed, one researcher had it at USD $700 million back in 2009 and projected it would be at USD $1.7 billion by 2018.


The incumbent competition is zero. You read that right. The gold standard for the past 2 decades - rapid acting fentanyl products - have all been pulled from the market due to the opioid crisis and restrictive FDA red tape.

As a result, the market is wide open for a safe alternative to replace the giant gap left behind from rapid acting opioids withdrawal.

In their absence, current treatments for BTcP include OxyNorm and Oxycodone pills. These take 1 hour to reach peak effect making them not only highly addictive, but far too slow acting to treat BTcP, which peaks in 5 to 10 minutes.


As a result, BTcP needs a super fast acting pain relief solution whose effects don't linger long beyond the duration of the pain attack (about 1 hour if untreated).

Enter IRX 211.

IRX 211 solves the 3 biggest issues: it's non-opioid, super fast acting, and precision dosage.

While non-opioid provides the headlines for this rare high value market gap opportunity, it is these 2 other advantages that enhance it. We've read from Syqe's clinical study that inhaled THC comes on almost instantly and peaks comfortably before 5 minutes.

This is the absolute sweet spot to treat BTcP attacks and, ironically, it would be an even faster acting improvement than the discontinued rapid acting fentanyl products.

This speed when combined with precision dosage is particularly useful because if after a few minutes patients still feel pain, they can continue to take more puffs until they reach their desired subjective pain relief.

What might be the biggest unforeseen bonus is evidence that THC has synergistic benefits when combined with opioids.

This would be especially advantageous to cancer patients as they are already on long duration opioids to treat their baseline cancer pain. That is, IRX 211 would be an adjunctive treatment only given for BTcP episodes.

If IRX 211 when combined with long duration opioids demonstrates greater pain control with fewer side-effects, it may well pave the way for lower doses of opioids to achieve the same amount of pain relief. This is known as the opioid sparing effect.

So far, studies in mice and monkeys are highly encouraging but there is also growing evidence of synergistic benefits in humans, too:
Combined Treatment with Morphine and Δ9-Tetrahydrocannabinol in Rhesus Monkeys: Antinociceptive Tolerance and Withdrawal - The Journal of Pharmacology and Experimental Therapeutics
Synergistic interactions between cannabinoid and opioid analgesics - PubMed
The Benefits and Effects of Using Marijuana as a Pain Agent to Treat Opioid Addiction | Insight Medical Publishing

The next round of news is batch manufacturing and first patient first dose, which could well be the catalyst for the stock to breakout and get an overdue market rerate. At the current market capital & low SOI, even a modest rerate could easily see the share price climb multiples from here and still be undervalued to peers.

With acknowledgment & thanks to @sapporo for the Syqe & opioid synergies research.
IMO & GLTAH