FDA gives the green light for revolutionary painkiller that changes everything and curbs addiction risk
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In a groundbreaking move that could change the landscape of pain management, the US Food and Drug Administration (FDA) has given the green light to a new painkiller that promises to eliminate the risks of addiction and overdose.
This is a beacon of hope for millions who suffer from pain but fear the grip of addiction that drugs like Vicodin and OxyContin can hold.
Introducing Journavx, the brainchild of Vertex Pharmaceuticals, this new medication is designed for short-term pain typically experienced after surgeries or injuries.
It represents the first novel pharmaceutical approach to treating pain in over two decades, offering an alternative to the traditional routes of opioids and over-the-counter medications such as ibuprofen and acetaminophen.
The path to this innovative drug has been anything but short. Vertex began its research in the 2000s, a time when opioid overdoses were surging, largely due to the over-prescription of painkillers for conditions like arthritis and back pain.
Although prescriptions have since decreased, the opioid epidemic persists, now primarily fueled by illicit substances like fentanyl.
Journavx's development reflects a determined effort to find new ways to manage pain without the devastating consequences of addiction.
Clinical studies involving more than 870 patients with acute pain from foot and abdominal surgeries showed that Journavx provided more relief than a placebo.
However, it's important to note that it did not outperform a common opioid-acetaminophen combination pill in terms of effectiveness.
“It’s not a slam dunk on effectiveness,” expressed Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not part of the research. “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot of promise.”
What sets Journavx apart is its unique mechanism of action. Unlike opioids, which reduce pain by binding to receptors in the brain, potentially leading to addiction, Journavx works by blocking proteins responsible for triggering pain signals before they even reach the brain.
Dr. David Altshuler of Vertex explained, “In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain.”
While Journavx does come with its own set of side effects—nausea, constipation, itching, rash, and headache—these are inherently different from those associated with opioids. Most notably, Journavx does not carry the risk of substance abuse.
Source: Pharmacist Michael / Youtube.
Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug's development, emphasized the significance of this new medication's side effect profile, which steers clear of the risks of addiction and other severe consequences linked to opioids.
One potential hurdle for Journavx is its cost. At $15.50 per pill, it is significantly more expensive than generic opioids, which can cost $1 or less.
This price point may pose a challenge for widespread adoption, especially in a healthcare system already burdened by high costs.
Despite a setback in a mid-stage study for chronic nerve pain, which saw the drug performing no better than a placebo, Vertex remains optimistic.
The company plans to forge ahead with a new, late-stage study, hoping that a different trial design could lead to better results and, eventually, FDA approval for chronic pain.
Also read: The $7 billion Sackler & Purdue Pharma lawsuit exposed–Everything you need to know.
What are your thoughts on this new development in pain management? Have you or someone you know been affected by the opioid crisis? Share your stories and insights in the comments below!
This is a beacon of hope for millions who suffer from pain but fear the grip of addiction that drugs like Vicodin and OxyContin can hold.
Introducing Journavx, the brainchild of Vertex Pharmaceuticals, this new medication is designed for short-term pain typically experienced after surgeries or injuries.
It represents the first novel pharmaceutical approach to treating pain in over two decades, offering an alternative to the traditional routes of opioids and over-the-counter medications such as ibuprofen and acetaminophen.
The path to this innovative drug has been anything but short. Vertex began its research in the 2000s, a time when opioid overdoses were surging, largely due to the over-prescription of painkillers for conditions like arthritis and back pain.
Although prescriptions have since decreased, the opioid epidemic persists, now primarily fueled by illicit substances like fentanyl.
The US Food and Drug Administration has approved a new painkiller called Journavx. Image source: Sookyung An / Pixabay.
Journavx's development reflects a determined effort to find new ways to manage pain without the devastating consequences of addiction.
Clinical studies involving more than 870 patients with acute pain from foot and abdominal surgeries showed that Journavx provided more relief than a placebo.
However, it's important to note that it did not outperform a common opioid-acetaminophen combination pill in terms of effectiveness.
“It’s not a slam dunk on effectiveness,” expressed Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not part of the research. “But it is a slam dunk in that it’s a very different pathway and mechanism of action. So, I think that shows a lot of promise.”
What sets Journavx apart is its unique mechanism of action. Unlike opioids, which reduce pain by binding to receptors in the brain, potentially leading to addiction, Journavx works by blocking proteins responsible for triggering pain signals before they even reach the brain.
Dr. David Altshuler of Vertex explained, “In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain.”
While Journavx does come with its own set of side effects—nausea, constipation, itching, rash, and headache—these are inherently different from those associated with opioids. Most notably, Journavx does not carry the risk of substance abuse.
Source: Pharmacist Michael / Youtube.
Dr. Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug's development, emphasized the significance of this new medication's side effect profile, which steers clear of the risks of addiction and other severe consequences linked to opioids.
One potential hurdle for Journavx is its cost. At $15.50 per pill, it is significantly more expensive than generic opioids, which can cost $1 or less.
This price point may pose a challenge for widespread adoption, especially in a healthcare system already burdened by high costs.
Despite a setback in a mid-stage study for chronic nerve pain, which saw the drug performing no better than a placebo, Vertex remains optimistic.
The company plans to forge ahead with a new, late-stage study, hoping that a different trial design could lead to better results and, eventually, FDA approval for chronic pain.
Also read: The $7 billion Sackler & Purdue Pharma lawsuit exposed–Everything you need to know.
What are your thoughts on this new development in pain management? Have you or someone you know been affected by the opioid crisis? Share your stories and insights in the comments below!
