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Suzetrigine - a novel drug for pain
Chronic Pain | Last Active: 19 hours ago | Replies (252)Comment receiving replies
Confused about what this drug actually can treat. The good Rx article mentions neuropathy, particularly diabetic neuropathy, and makes a comment about peripheral nerves. But will it be used to treat nerves in the spine? I have severe lumbar stenosis and pain in glutes, hamstrings, calves, ankles. Are the researchers looking for applications for spinal stenosis?
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Journavx is being marketed for acute (short-term) significant pain. Classic instance would be surgery for broken bones, etc. The phase 2 trial was apparently equivocal, & even it only sought short-term benefit for acute pain. NOT chronic pain.
Severe stenosis? Sorry: they won't be applying for that kind of application until at least after a Phase 3 trial for acute pain.
That doesn't mean your MD can't apply to use it off-label for chronic pain, especially under the Compassionate Care Act if you qualify. But again, that won't likely be a possibility until after a Phase 3 trial reports. That's a few years away, best case.
I do expect there'll be a rush of requests for off-label use, & suspect the pharma company is counting on that. Doctors are under tremendous pressure to reduce their prescription of opioids; patient demand for non-opioid pain meds that work is enormous. I'm sure the pharma company realizes it's sitting on a golden goose & they'd better not F it up by rushing to market, appearing to too obviously game the approvals process, or look too greedy.
If this stuff is relatively side-effect free, not too expensive and actually IS as effective as opiates, there's not only a Nobel prize in store for them, it'll be the blockbuster of the century.
I'm not them - especially not their lawyers - but I'd argue for speedy approval to provide under the Compassionate Care Act free or at very affordable price, on condition that all such use be tracked & outcomes reported meticulously. Such a process would tell the FDA more than even a large Phase 3 trial while demonstrating compassion & concern for patients. And should demonstrate just how amazing such a drug is. They could even supply it free: this kind of program would create more and better data than a Phase 3 trial at a tiny fraction of the cost. No way would such a program cost $20-30 million, and that's the cost of an ineffectually-small phase 2 trial today. A bargain! All while generating market awareness & demand - advertising-free - and generating enormous goodwill. A bargain!