Massive news which is both very relevant and promising for future FDA approval of IRX 211 for breakthrough cancer pain.
The FDA has just approved Qamzova as a non-opioid alternative for some types of cancer pain in the fight against America's opioid crisis. The good news doesn't stop there either.
Qamzova is injected through a syringe and here's the real eye opener - it was developed in China by a Chinese company!!
Considering Trump's recent anti-China stance, it shows us just how high finding alternatives to deadly opioids sit on Trump and the FDA's list of priorities.
Let's break down what Qamzova's approval could mean for us:
- It signals the FDA's willingness to approve non-opioid alternatives for cancer pain.
- It shows the FDA are open to alternative delivery methods such as injections, which increases the likelihood of FDA approval for much more patient friendly inhalation.
- It demonstrates the FDA are willing to approve non-opioid drugs developed and/or trialed outside the USA.
This sets up a favorable regulatory precedent for IRX 211 as a non-opioid alternative for breakthrough cancer pain.
It is important to emphasize here that Qamzova is not a competitor to IRX 211.
Qamzova provides long acting pain relief (24 hours) but has a delayed onset (4-6 hours) making it completely unsuitable for sudden, intense pain. By contrast, IRX 211 should provide near immediate pain relief because it enters the bloodstream in minutes.
The FDA know cancer sufferers need immediate pain relief during pain flare ups and fast acting opioids are well on the way out. There is now a clear niche for IRX 211 for fast acting pain relief - a critical market gap.
It is really exciting news because Qamzova has shown us it can be done; this is why it is so important for the company to get a wriggle on. The FDA window of opportunity is currently wide open for non-opioid alternatives.
If IRX 211 can show safety, efficacy, and rapid onset of action in the upcoming phase 2, FDA approval is not just possible, it's increasingly probable.
FDA Approves Qamzova: China-Developed Long-Acting Injectable Painkiller to Combat Opioid Crisis
GLTAH
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