Acetaminophen/Hydrocodone Bitartrate

Plus, news about Tris Pharma and ARS Pharmaceuticals: Merck KGaA’s lupus drug yields mixed data in mid-stage trial: The drugmaker’s TLR7/8 inhibitor, called enpatoran, missed one of two Phase 2 primary endpoints in a cohort of patients with systemic lupus erythematosus, according to chief financial officer Helene von Roeder on the company’s earnings call on Thursday. The drug previously showed promise patients with cutaneous lupus in the same trial, and Merck said the overall data support further development. — Ayisha Sharma Zymeworks deprioritizes ADC: The company is pausing Phase 1 development of ZW220, which is designed to target sodium-dependent phosphate transporter 2b. It had been considering testing the ADC in ovarian and non-small cell lung cancer. Zymeworks noted that the program still has “strong commercial rationale with partnership potential.” — Max Gelman Tris Pharma reports another Phase 3 success for pain drug: The treatment, called cebranopadol, succeeded in a trial measuring its pain reduction abilities after surgical bunion removal. The win comes less than two months after a Phase 3 study in patients who had undergone tummy tucks also met its primary endpoint. The drug is designed to target the pathway used by painkillers like Vicodin and morphine to create their sedative and analgesic effects as well as another receptor that has a “modulatory role” on that pathway (though it still belongs to the broader family of opioid receptors). — Max Gelman ARS Pharmaceuticals’ neffy gets another approval: The company said Wednesday that the FDA approved neffy 1 mg to treat Type I allergic reactions in children who are at least 4 years old and hit a weight requirement. The nasal spray was first approved in the US last summer. — Jaimy Lee Editor’s note: This article and its headline were corrected to note that Merck KGaA’s lupus trial had mixed data and to correct a quote attribution. A previous version of the article incorrectly stated that the trial had failed.

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.