Patients may soon be able to get the first novel sort of painkiller in more than 20 years, according to encouraging findings from a corporate trial released on Tuesday.
The Vertex Pharmaceuticals medication is currently known as VX-548. However, VX-548 outperformed a placebo in reducing post-operative pain in patients undergoing foot bunion operations and abdominoplasties (tummy tucks), and no significant safety concerns were observed.
The research concluded that although it did not provide better pain relief than the opioid Vicodin (hydrocodone bitartrate/acetaminophen), it did score comparably to Vicodin on a common assessment known as the Numeric Pain Rating Scale. Vertex President and CEO Dr. Reshma Kewalramani stated in a company release, “We are very pleased with the results from the VX-548 pivotal program, which demonstrate a compelling and consistent combination of efficacy and safety across multiple acute pain conditions and settings.”
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A Novel Painkiller
A Novel Painkiller
She stated that Vertex is “working with urgency to… bring this non-opioid medicine to the millions of patients who suffer from acute pain each year in the U.S.” and mentioned that the medication is already expedited for clearance by the U.S. Food and Drug Administration. Opioid drugs, while effective in reducing pain, have significant dangers of addiction and abuse, leaving millions of patients worldwide in search of an alternative. As an associate physician in emergency medicine and pain medicine at the University of California, San Diego, Dr. Jessica Oswald stated in the Vertex news release, “I know firsthand the critical need for new, efficacious, and safe treatment options as a physician treating patients suffering from pain for many years.”
A Novel Painkiller
She called the findings on VX-548 “impressive,” with the “potential to change the paradigm of pain management. I look forward to the potential of having a new class of acute pain medicine—the first in more than two decades—to use as an alternative to opioids to help the millions of people impacted by acute pain.”Just how does VX-548 work? As the company explained, the drugs don’t work directly on the brain but instead target cellular processes within the peripheral nervous system. More specifically, VX-548 targets a cellular mechanism called a sodium channel, in this case the sodium channel NaV1.8. NaV1.8 “plays a critical role in pain signaling in the peripheral nervous system,” Vertex said.
A Novel Painkiller
In the new trial, Vertex enrolled about 1,100 people who’d undergone tummy tuck surgeries and a similar number who’d had bunion surgeries. Patients got either a placebo, Vicodin (every six hours for 42 hours) or VX-548—first at a dose of 100 milligrams (mg) and then again at a 50-mg dose every 12 hours for the next 36 hours. All were given in pill form. On a standard measure gauging patients’ pain intensity, VX-548 had scores that easily outperformed the placebo.
A Novel Painkiller
Compared to Vicodin, VX-548 was roughly equal in pain relief for the abdominoplasty patients and less effective than Vicodin among the foot surgery patients. But using the Numeric Pain Rating Scale, VX-548 and Vicodin showed similar pain reductions: 47% and 43%, respectively, for the tummy tuck patients, and 51% and 53%, respectively, for people who underwent bunion surgeries. As for safety, “VX-548 was generally well-tolerated in this study,” the company said. “The majority of adverse events [AEs] were mild to moderate,” with the most common issues involving nausea or constipation.
A Novel Painkiller
images source: Google
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