Disclosure: I have no financial stakes in the company, nor do I know of anyone who does.

FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
First Drug Approved in New Class of Non-Opioid Pain Medicines

January 30, 2025

Today, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

Journavx is the first drug to be approved in this new class of pain management medicines.

Pain is a common medical problem and relief of pain is an important therapeutic goal. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery. Acute pain is often treated with analgesics that may or may not contain opioids.

The FDA has long supported development of non-opioid pain treatment. As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of clinical practice guidelines for the management of acute pain conditions.

“Today’s approval is an important public health milestone in acute pain management,” said Jacqueline Corrigan-Curay, J.D., M.D., acting director of the FDA's Center for Drug Evaluation and Research. “A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option. This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

The efficacy of Journavx was evaluated in two randomized, double-blind, placebo- and active-controlled trials of acute surgical pain, one following abdominoplasty and the other following bunionectomy. In addition to receiving the randomized treatment, all participants in the trials with inadequate pain control were permitted to use ibuprofen as needed for “rescue” pain medication. Both trials demonstrated a statistically significant superior reduction in pain with Journavx compared to placebo.

The safety profile of Journavx is primarily based on data from the pooled, double-blind, placebo- and active-controlled trials in 874 participants with moderate to severe acute pain following abdominoplasty and bunionectomy, with supportive safety data from one single-arm, open-label study in 256 participants with moderate to severe acute pain in a range of acute pain conditions.

The most common adverse reactions in study participants who received Journavx were itching, muscle spasms, increased blood level of creatine phosphokinase, and rash. Journavx is contraindicated for concomitant use with strong CYP3A inhibitors. Additionally, patients should avoid food or drink containing grapefruit when taking Journavx.

The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA.

The FDA granted approval of Journavx to Vertex Pharmaceuticals Incorporated.

I wonder if chronic sufferers of pain will be able to use this on a long term basis?


At $31 a day, is Vertex’s new non-addictive painkiller worth the price?

https://archive.ph/9sanx

Will people with acute pain want a new painkiller whose list price is $15.50 a pill when a generic prescription drug is at least as effective and costs only 50 cents a pill?

Soon after the approval, Vertex announced that the drug will cost $31 a day for two 50-milligram pills that are taken 12 hours apart for pain from an injury or surgery.

More at link

I seem to recall they said Oxy would be non-addictive, no?

quote:

Originally posted by r0gue:
I seem to recall they said Oxy would be non-addictive, no?

Yes, they knew it was addictive, lied about it, and bribed the regulators to get it labeled as such.

I’ll wait and see on this one.

quote:

Originally posted by wcb6092:
I wonder if chronic sufferers of pain will be able to use this on a long term basis?...

I'm pretty sure they will eventually do that down the road. Just like lamotrigine (brand name Lamictal), originally approved for the treatment of some seizure disorders but later was approved for others, plus bipolar disorder. Also has many off-label uses.

Cautiously optimistic, but I doubt that this will be some panacea of pain management. This med has the (essentially) same mechanism of action as that of local anesthetics. I've done a lot of trials of IV lidocaine for post-operative pain over the past few years and while it can help, it ain't all that great.

I remain in the narcotic camp. They work, and they work well.

I too are in the narcotic camp, they do work well.

They, like everything in Anesthesia and pain management have baggage, significant baggage. Everything we do is a risk vs benefit for each individual.

It will be interesting to see what the Baggage is going to be with this newest pain reliever.

You don't get something for nothing in medicine, and I am not talking about money.

There is always a risk or downside to everything you get done.

quote:

Originally posted by alreadydead:
I too are in the narcotic camp, they do work well.

They, like everything in Anesthesia and pain management have baggage, significant baggage. Everything we do is a risk vs benefit for each individual.

It will be interesting to see what the Baggage is going to be with this newest pain reliever.

You don't get something for nothing in medicine, and I am not talking about money.

There is always a risk or downside to everything you get done.

Amen ! I can't think of any drug that is 100% safe...even placebo !!
My gripe is folks who think we can simply pull something out of the air that is super effective and 100% safe.
Hell, untreated pain has risks too.....

quote:

Originally posted by mike28w:
My gripe is folks who think we can simply pull something out of the air that is super effective and 100% safe.

That, and the expectation nowadays that life is guaranteed to be a pain free experience.

Chronic pain sucks, it’s no joke. I’d love a non narcotic option that *works*.

quote:

Originally posted by alreadydead:
I too are in the narcotic camp, they do work well.

They, like everything in Anesthesia and pain management have baggage, significant baggage. Everything we do is a risk vs benefit for each individual.

It will be interesting to see what the Baggage is going to be with this newest pain reliever.

You don't get something for nothing in medicine, and I am not talking about money.

There is always a risk or downside to everything you get done.

So true. I remember vioxx when it came out - worked great! Then The black box warnings and eventual removal from the market

As someone who has had both knees replaced since August I can says for certain that I'm only interested in pain relief that works. I don't care about addiction or anything else, just pain relief until I don't need pain relief anymore.
My surgeon prescribed these medications 3 times a day. Oxy three times a day along with aspirin, Gabapentin,Acetaminophen (2),Tramadol (2),and Meloxicam.
Along with ice and compression these meds did a good job. I took the "pain" relief drugs for about 3 weeks, then only when needed.
I would NOT be interested in being a Ginney pig to see how another drug might work. I'm sure there is a "unexpected" side effect ( that I'm sure will be hidden by Pharma for years) that goes with the new pain relief.

The world of X seems to be dead set against “Big Pharma”. There are lots of problems with pharmaceutical companies and their political power. Actual bribery of physicians, at least, is long in the past.
But the US still pays for the vast majority of pharmaceutical research, through both public and private funding, and as a result we get a few really useful new drugs; a moderate number of drugs for more rare conditions which are enormously expensive; and a lot of copy-cat drugs that are marketed heavily.
In my opinion in this milieu the FDA does a good job of reviewing drug applications and working with pharma companies to get through the Phase I, II and III trials to show evidence of safety and effectiveness.
These new drugs would not happen without the profit incentive.
So I’m very concerned about what opponents of Big Pharma would do to improve safety and effectiveness, and yet decrease cost.
How would they prove safety and effectiveness without RCT’s?

I too am not a fan of Big Pharma....but if the "Big Pharma Hate craze" is taken to the extreme, then there is little incentive to spend big bucks on research.

All that Big Pharma will sell is old drugs, whose risks are completely known (and are approved by their lawyers). That is the financially safe route.

quote:

Originally posted by dry-fly:
Chronic pain sucks, it’s no joke. I’d love a non narcotic option that *works*.

Yep, my wife has rheumatoid arthritis and deals with pain every day.

I am grateful that I never had the slightest inclination to addiction to opioids. I took them for my back and still have some scripts from over 10 years ago (could be longer, I’d have to check).