New and Noteworthy from The New York Times, original article by Gina Kolata
Boston-based Vertex Pharmaceuticals said on Tuesday that it had created an experimental medication that blocks pain impulses before they reach the brain, relieving moderate to severe pain. Unlike opioids, it acts only on peripheral nerves, or those that are not part of the brain or spinal cord. According to Vertex, the possibility for opioid addiction to develop is avoided by their new medication.
The company said that it has finished two randomized studies: 1,118 individuals underwent abdominoplasties in the first study, and 1,073 individuals underwent bunion surgery in the second study. The two techniques are frequently applied in research with individuals experiencing acute pain—that is, the transient form that results from an event such as surgery and usually goes away over time.
Vertex used a standard pain scale in its clinical studies to quantify the impact of the medicine. Patients rated their pain on a scale of 1 to 10, with 10 being the most severe. It indicates that there was a statistically and clinically significant decrease in pain among those using the medication. A third research examined the drug's safety and tolerability in patients suffering from a range of pain issues.
Encouraged by the findings—which have not yet been made public or discussed at a meeting—Vertex intends to submit an application for approval to distribute the medication, a tablet currently known as VX-548, to the Food and Drug Administration by the middle of the year.
Dr. Henry Kranzler, professor of psychiatry and director of the Center for Studies of Addiction at the University of Pennsylvania’s Perelman School of Medicine, called the drug “a therapeutic breakthrough.”
He said its development was based on a strong body of science and, at least for acute pain, “it looks very promising” with an efficacy that, while not better than the opioid oxycodone, also is not worse.
“This has the potential to be a blockbuster,” said Dr. Stephen Waxman, a professor of neurology, neuroscience and pharmacology at Yale. Dr. Waxman was not associated with the study but was paid a $1,000 speaking honorarium by the company. He predicted that the Vertex drug would be only the first foray into this new area.
“I like to think it’s the beginning of nonaddictive medicines for pain,” he said.
That, said Dr. James P. Rathmell, professor of anesthesia at Harvard Medical School, “is the dream all of us in this business have had for a long time.”
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New York Times Article:
https://www.nytimes.com/2024/01/30/health/vertex-pain-medicine-non-opioid.html