Acetaminophen/Hydrocodone Bitartrate

FRIDAY, Jan. 31, 2025 -- The U.S. Food and Drug Administration (FDA) has approved Journavx , a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin . The new pill, developed by Vertex Pharmaceuticals , is intended for short-term pain relief following surgery or injury, the Associated Press reported. While it provides a long-awaited alternative to opioids and over-the-counter painkillers like ibuprofen , research suggests its effectiveness is modest compared to standard opioid treatments. Unlike opioids, which bind to brain receptors to reduce pain but often lead to dependence and addiction, Journavx works differently. The medication blocks specific proteins that trigger pain signals before they reach the brain. “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,” Dr. David Altshuler , Vertex’s executive vice president and chief scientific officer, previously told the Associated Press. Studies of more than 870 patients who took Journavx after foot and abdominal surgery showed that the drug provided more relief than a placebo but was not more effective than a common opioid-acetaminophen combination pill. “It’s not a slam dunk on effectiveness,” Michael Schuh of the Mayo Clinic, a pharmacist who was not involved in the research, told the Associated Press . “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.” One major concern is cost. Journavx will have a list price of $15.50 per pill, compared to generic opioids, which cost $1 or less. Some reported side effects included nausea, constipation, itching, rash and headache, but no risk of addiction. “The new medication has side effect profiles that are inherently, not only different, but don’t involve the risk of substance abuse and other key side effects associated with opioids,” Dr. Charles Argoff of the Albany Medical Center in New York, who consulted for Vertex on the drug’s development, told the Associated Press . The approval marks the first major advancement in pain treatment in more than two decades. Vertex began developing the drug in the early 2000s, as opioid overdoses surged due to mass prescribing for chronic conditions like arthritis and back pain. While opioid prescriptions have sharply declined in recent years, the current epidemic is mostly fueled by illicit fentanyl, rather than pharmaceutical opioids, the Associated Press reported. Vertex has attracted much interest, but the drugmaker's stock took a hit in December after disappointing results in a study of chronic nerve pain. Despite this, the company plans to continue with another late-stage trial in hopes of getting FDA approval for chronic pain treatment. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

A novel Vertex Pharmaceuticals drug that takes a new approach to pain is now approved by the FDA, a landmark decision for a first-in-class product that brings patients a treatment alternative intended to avoid the addiction risks posed by opioid medications. The regulatory decision announced late Thursday covers the treatment of moderate-to-severe acute pain in adults. Acute pain is defined as pain that lasts less than three months, such as aches following an injury or a surgical procedure. The Boston-based company’s new drug, a twice-daily pill known in development as suzetrigine, will be marketed under the brand name Journavx. “Today’s approval is an important public health milestone in acute pain management,” Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in the agency’s approval announcement. “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.” Exclusive Improving the Healthcare Financial Experience to Help Care Flow Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. By Stephanie Baum The addiction risks of opioids come from their targeting of receptors in the central nervous system. But before pain signals reach the brain, they travel across pathways in the peripheral nervous system. Journavx targets one of these pathways, a sodium channel called NaV1.8. The drug is a small molecule designed to selectively block this channel without hitting other related sodium channels, which could lead to adverse effects. The drug comes from a pain research program that began at Vertex about 25 years ago. FDA approval of Journavx is based on the results of two Phase 3 studies, one that tested the drug after abdominoplasty (tummy tuck) surgery and the other after bunionectomy surgery. Both studies met the main goal of showing statistically significant improvement compared to placebo according to a pain rating scale. The studies also included as a comparator the drug Vicodin, an inexpensive painkiller that pairs the opioid hydrocodone with the main pharmaceutical ingredient in Tylenol. On this secondary trial measure, the results were disappointing. In tummy tuck patients, the numerical improvement achieved by suzetrigine fell short of statistical significance compared to Vicodin. In bunion surgery patients, Vicodin beat suzetrigine. The Vertex drug was safe and well tolerated in these studies. Vertex reported no addiction problems in the studies. Vertex is also developing Journavx for chronic pain, but there have been mixed results so far. In a Phase 2 test in painful lumbosacral radiculopathy (lower back pain), data released last month showed that despite meeting the main goal according to a pain rating scale, the placebo arm posted a similar response. The study was not powered or designed to show differentiation from placebo, but Vertex’s stock price still took a hit. The company said it plans to advance the drug to a pivotal test in this indication, pending discussions with regulators. A Phase 3 test in painful diabetic peripheral neuropathy is ongoing. In a note sent to investors after the back pain trial readout, William Blair analyst Myles Minter said the lack of separation from placebo in that trial increases the risk for the ongoing Phase 3 diabetic peripheral neuropathy test. presented by Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum Vertex set a $15.50 per pill price for Journavx. That’s slightly higher than the $12 per pill price that Leerink Partners modeled. A December report by the Institute for Clinical and Economic Review concluded that compared to treatment with Vicodin, the Vertex drug would lead to savings that mainly come from avoiding the excess healthcare costs associated with opioid use disorder. A recent regulatory change should support reimbursement of the new Vertex product. The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act took effect on Jan. 1, requiring Medicare to provide separate reimbursement for qualifying non-opioid pain drugs. A goal of the legislation is to increase access to alternative pain drugs to reduce opioid use. Leerink analyst David Risinger wrote in a research note that the Journavx label represents the best-case scenario for Vertex. There is no language for addiction or abuse potential, which Leerink expects will be critical to the drug’s utilization. The firm sees Journavx as the first in a series of novel non-opioid pain medicines coming from Vertex. Risinger said Leerink projects Journavx and follow-on NaV1.8 inhibitors for acute and neuropathic pain could top $10 billion in peak sales. That’s important for Vertex, which is working to diversify its portfolio beyond the cystic fibrosis products that currently bring in the vast majority of its revenue. Photo by Vertex Pharmaceuticals