abdominoplasty –commonly known as a “tummy tuck
bunionectomy — surgically reduce a bony bump that forms at the base of the big toe
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 (SUGAR TABS/CAPS)
The application received Breakthrough Therapy, Fast Track and Priority Review designations by the FDA
According to this article, a New Class of Non-Opioid Pain Medicines – Journavx’s maker Vertex Pharmaceuticals was granted Fast Track approval.
In CONCLUSION, the med Journavx is better that placebo (sugar) doses, but pts were given Ibuprofen – no strength mentioned – for break-thru ACUTE PAIN!
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
First Drug Approved in New Class of Non-Opioid Pain Medicines; Agency Continues to Take Steps to Support New Approaches for Pain Management
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 As part of the FDA Overdose Prevention Framework, the agency has issued draft guidance aimed at encouraging development of non-opioid analgesics for acute pain and awarded cooperative grants to support the development and dissemination of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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
Filed under: General Problems
It certainly doesn’t sound as if it’s made to treat moderate-severe pain. One news article that I read claimed this medication can prevent acute pain from transitioning to chronic pain, while another article noted that it wasn’t actually compared with Vicodin during the trials, yet it’s being touted as providing the same (or better) relief. The latter article also noted that it may not work for everyone and that it may not treat some types of pain. That’s great for anyone who reads the latter article, but all of the other ones seem to be giving it the anticipated royal treatment as the magic bullet in the fight against the opioid crisis. Which is sad in and of itself, since medications should be made to actually do the thing they’re supposed to do, not for optics. Given what I already knew about it (thanks to you, Steve), it doesn’t sound very promising for the vast majority and I certainly would not have expected the “moderate to severe pain” rating. I have complex issues with a variety of different types of medications, so I would be highly reluctant to try it myself. If it works for someone out there, then I am happy for them. However, I can’t shake the feeling this med is going to become the new pregablin/gabapentin/epidural injections/SCS in that it may end up being “mandatory” if one wishes to continue to be seen/treated (off record, of course). I can’t shake the feeling that patients who are currently receiving opioids are going to report insistence that they try it and if it does not work, patients will then report being shouted at that they aren’t going back on opioid pain medication. Of course, I could be wrong. Maybe it’ll work wonders. Maybe providers won’t view it as if they’ve found “the way” and insist on trying their patients on this med. But if history is any indicator, I don’t have a lot of hope in that arena. I honestly hope that I am wrong. It would be nice for something to go like it does for patients who don’t have chronic pain for once.