WASHINGTON — On Thursday, U.S. federal authorities granted approval for a novel pain medication aimed at addressing the challenges surrounding addiction and overdose linked to traditional opioid drugs such as OxyContin and Vicodin.
The U.S. Food and Drug Administration (FDA) announced its endorsement of Vertex Pharmaceuticals’ Journavx, intended for managing short-term pain often experienced after surgical procedures or injuries.
This marks a significant development in pain management, being the first new pharmacological approach in over two decades. It presents an alternative not just to opioids but also to over-the-counter options like ibuprofen and acetaminophen. However, the drug’s limited effectiveness and the lengthy process of its development highlight the complexities involved in discovering new pain relief methods.
Clinical trials involving over 870 patients who underwent foot and abdominal surgeries revealed that Vertex’s medication offered more relief than a placebo; however, it did not prove to be more effective than a standard opioid-acetaminophen combination.
“It’s not an overwhelming success in terms of effectiveness,” noted Michael Schuh, a Mayo Clinic pharmacist and pain specialist who was not part of the study. “However, it is a significant advancement in that it utilizes a completely different mechanism of action, which is very promising.”
The drug is projected to be priced at $15.50 per pill, making it considerably more expensive than typical opioids, which can frequently be found as generics for $1 or less.
Vertex began its research on this medication in the 2000s, during a period when opioid prescriptions surged dramatically for everyday conditions like arthritis and back pain, contributing to rising overdose rates. Although opioid prescriptions have declined considerably over the past ten years, the current opioid crisis is primarily fueled by illicit fentanyl, rather than prescription medications.
Opioids work by attaching to receptors in the brain that process pain signals from various parts of the body, which also leads to their addictive properties. In contrast, Vertex’s drug functions by inhibiting specific proteins that transmit pain signals to the brain.
According to Dr. David Altshuler from Vertex, the focus on developing non-addictive pain medications hinges on intercepting pain signals before they reach the brain.
The drug is associated with some common side effects, including nausea, constipation, itching, rash, and headaches.
“The new medication has side effect profiles that are not only distinct but also devoid of the substance abuse risks and other notable side effects tied to opioid use,” asserted Dr. Charles Argoff from Albany Medical Center, who provided consultancy during the drug’s development.
The innovative approach to targeting pain-signaling proteins stemmed from studies involving individuals suffering from a rare genetic condition that renders them insensitive to pain.
Vertex has garnered attention from investors for its ambitious plans in developing a diverse array of drugs aimed at gaining FDA approval for various forms of chronic pain, which could represent a more lucrative market than acute pain relief.
However, the Boston-based company’s share prices took a hit in December after disappointing mid-stage trial results for a medication targeting chronic nerve pain in the back and legs, which did not show significant improvement over a placebo.
“Data from this trial seem to reflect a near worst-case scenario for this crucial program,” biotechnology analyst Brian Abrahams commented in a note to investors, suggesting that these outcomes jeopardized the potential multi-billion-dollar valuation of Vertex’s pipeline.
Despite the setbacks, Vertex executives remain committed to progressing to a new late-stage trial for the drug, believing that alternate trial designs might lead to improved outcomes and pave the way for FDA approval for chronic pain conditions.
