In this article, the Food and Drug Administration has approved Vertex Pharmaceuticals’ non-opioid painkiller pill, providing a new option for pain relief without the risk of addiction. Vertex has become the first drugmaker in years to receive U.S. approval for a novel type of pain medication. This achievement follows numerous unsuccessful attempts to create painkillers that do not lead to the harmful dependency associated with opioids, which have caused a devastating epidemic of abuse and overdose in the United States.
The newly approved drug, Journavx, is specifically designed to treat moderate to severe acute pain resulting from injuries, surgeries, illnesses, trauma, or painful medical procedures. Approximately 80 million patients in the U.S. are prescribed medication for their moderate to severe acute pain annually, according to Vertex. Studies have shown that nearly 10% of patients initially treated with opioids for acute pain may develop prolonged opioid use, with around 85,000 individuals developing opioid use disorder each year, as stated by Vertex.
Dr. Reshma Kewalramani, Vertex’s CEO, expressed optimism about changing the approach to acute pain management and setting a new standard of care. Journavx will be priced at $15.50 per 50-milligram pill, with analysts predicting potential blockbuster status and annual sales exceeding $1 billion if regulatory approval is granted.
The mechanism of action of Vertex’s treatment involves blocking pain signals at their source, preventing them from reaching the brain. This differs from opioids, which act directly on the brain to alleviate pain, potentially leading to addiction by stimulating the brain’s reward centers.
The FDA’s approval of Vertex’s painkiller underscores its dedication to endorsing safe and effective alternatives to opioids for pain management. Clinical trials demonstrated that Journavx was more effective than a placebo in reducing pain intensity after 48 hours in studies involving over 1,000 patients who underwent abdominoplasties and bunion surgeries, common procedures used to assess acute pain.
While the painkiller outperformed a placebo in reducing pain intensity, it did not meet the secondary objective of pain reduction compared to a combination of hydrocodone and acetaminophen. Adverse effects reported by patients who received Journavx included itching, muscle spasms, and rash, among others. In a separate phase three study, over 83% of patients rated the drug as good, very good, or excellent in alleviating pain following various surgical or nonsurgical procedures.
Vertex’s potential for further success lies in obtaining FDA approval for chronic pain management, an area where the risk of opioid addiction is higher. Positive results were observed in a mid-stage trial in 2023 involving diabetes patients with a chronic nerve condition.
