
Federal authorities have granted approval for a novel pain medication, aimed at addressing the risks of addiction and overdose that are common with traditional opioid treatments such as Vicodin and OxyContin.
The U.S. Food and Drug Administration announced the nod for Journavx, developed by Vertex Pharmaceuticals, which is intended for short-term relief following surgeries or injuries. This marks the first significant advancement in pharmaceutical pain management in over two decades, providing a new option alongside both opioids and over-the-counter alternatives like ibuprofen and acetaminophen. Despite the promise of this new treatment, its limited effectiveness and the extensive time taken for development highlight the difficulties in discovering new pain relief methods.
Clinical trials involving over 870 participants suffering from acute pain due to foot and abdominal operations revealed that Journavx offered superior relief compared to a placebo. However, it fell short of the results seen with a common compound pill combining opioids and acetaminophen. “Its effectiveness is not overwhelmingly strong,” stated Michael Schuh, a pharmacist and pain medicine specialist from the Mayo Clinic, who was not part of the trials. “Nevertheless, it represents a significant advancement in that it utilizes a distinct pathway and mechanism to alleviate pain, which is quite encouraging.”
The new medication is expected to retail at $15.50 per pill, a price significantly higher than many widely available generics of opioids, which can cost around $1 or even less. Vertex Pharmaceuticals began investigating this medication in the early 2000s, amid a surge in opioid-related overdoses fueled by widespread prescriptions for common conditions such as arthritis and lower back pain. While opioid prescriptions have markedly declined over the past ten years, the ongoing opioid crisis is now notably driven by the illegal use of fentanyl rather than prescribed medications.
Opioids operate by attaching to receptors in the brain that process pain signals from various body areas, which is also the reason for their addictive qualities. On the other hand, Vertex’s medication intervenes differently by obstructing the proteins that activate pain signals before they are forwarded to the brain. “Our goal in creating non-addictive pain medications is to inhibit pain signaling prior to it reaching the brain,” explained Dr. David Altshuler from Vertex, during an interview last year.
Reported adverse effects associated with the drug include nausea, headaches, rash, constipation, and itching. Dr. Charles Argoff of Albany Medical Center, who provided consultation on the drug, emphasized that the side effects are not only distinct but also devoid of the risks linked to substance abuse often seen with opioids.
The foundational idea behind targeting pain-signaling proteins stemmed from studies on individuals with a rare genetic disorder that results in a lack of pain sensitivity. Vertex has caught Wall Street’s attention due to its broad pipeline promising a range of drugs seeking FDA approval for various types of chronic pain, which generally holds a larger market potential compared to acute pain management.
However, Vertex experienced a dramatic fall in stock prices the previous December, following the announcement of unsatisfactory mid-stage trial results for a drug aimed at treating chronic nerve pain in the lower back and legs, which did not show significant improvement over a placebo. Biotechnology analyst Brian Abrahams remarked that the data presented a “near worst-case scenario” for this vital program, endangering the projections that the drug pipeline could yield billion-dollar revenues across various pain treatments.
Despite this setback, Vertex planning on initiating another late-stage trial for the drug, where different experimental designs may lead to more favorable outcomes, potentially enabling FDA approval for chronic pain management.