On Thursday, the Food and Drug Administration (FDA) granted approval to Vertex Pharmaceuticals' non-opioid painkiller pill, a new alternative for pain relief that does not carry the risk of addiction.
With this approval, Vertex becomes the first pharmaceutical company in 25 years to introduce a new class of pain medication in the United States. This milestone marks a breakthrough after years of mostly unsuccessful attempts to develop effective painkillers without the addictive potential of opioids, which have led to a devastating epidemic of misuse and overdose across the country.
Why It Matters
Vertex's medication, named Journavx, is seen as a major development in the ongoing effort to provide effective pain management solutions without the harmful consequences associated with opioid medications. This new option could offer hope for patients and healthcare providers seeking safer alternatives to address acute pain while mitigating the risks of addiction and dependency.
What To Know
Journavx has been specifically approved for the treatment of moderate-to-severe acute pain, which often results from injury, surgery, illness, trauma or painful medical procedures, and typically subsides over time. According to Vertex, approximately 80 million patients in the U.S. receive prescriptions for moderate-to-severe acute pain each year.
The FDA's approval process for Journavx included an evaluation of its safety and efficacy. Clinical trials demonstrated that the drug is effective in managing acute pain without the adverse effects commonly associated with opioid use.
Vertex Pharmaceuticals' development and approval of Journavx underscore the potential for new, innovative treatments in pain management. The company hopes that this new drug will offer effective pain relief while reducing the risk of dependency and misuse.
Public health experts have lauded the approval, hoping it will pave the way for further advancements and encourage other pharmaceutical companies to invest in similar research and development efforts.
What People Are Saying
Dr. Jacqueline Corrigan-Curay, acting director of the FDA's Center for Drug Evaluation and Research said in a press release: "Today's approval is an important public health milestone in acute pain management. 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."
Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research, told the Associated Press: "It's not a slam dunk on effectiveness. 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 promise."
What Happens Next
After the FDA approves a drug, the drug enters the post-marketing monitoring stage. The FDA continues to monitor the drug's safety, effectiveness and quality.
As Vertex Pharmaceuticals prepares to bring Journavx to market, the focus will be on educating healthcare providers and patients about its benefits and proper use.
The Associated Press contributed to this report.
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