In front of Vertex Pharmaceuticals’ global headquarters in Boston, you can spot a sign that symbolizes a new era in pain management. On Thursday, the Food and Drug Administration gave the green light to Vertex’s new opioid-free pain relief pill, promising a solution for pain sufferers that doesn’t carry the risk of addiction.
Vertex stands out as the first pharmaceutical company in several decades to receive U.S. approval for an entirely new category of pain medication. This marks a significant turning point after years of largely unsuccessful attempts to develop painkillers that do not foster the harmful dependencies associated with opioids, which have spurred a devastating crisis of misuse and overdoses across the United States.
The newly approved medication from Vertex, known as Journavx, targets moderate-to-severe acute pain—typically stemming from injuries, surgeries, illnesses, trauma, or medical procedures—and tends to alleviate over time. According to Vertex, doctors prescribe medication for such pain to about 80 million Americans each year.
Unfortunately, nearly 10% of those initially treated with opioids for acute pain develop long-term use, leading to about 85,000 new cases of opioid use disorder annually. This was highlighted by Vertex in their official announcement.
“We’re poised to transform the management of acute pain and set a new benchmark in patient care,” noted Dr. Reshma Kewalramani, CEO of Vertex, in her statement.
The pricing for Journavx will start at $15.50 for each 50-milligram dose. Analysts on Wall Street predict that, should the drug win further regulatory endorsement, it could potentially become a blockbuster, generating over $1 billion in annual sales.
Pain originates at a nerve ending; the body senses this and sends the signal up to the brain via the spinal cord. Vertex’s innovative approach stops these pain signals at the source before they ascend to the brain, contrasting with how opioids work. Opioids block pain in the brain itself, which can also activate the brain’s reward centers, often leading to addiction.
Dr. Jacqueline Corrigan-Curay, the acting director of the FDA’s Center for Drug Evaluation and Research, emphasized in a release that this approval reflects “the FDA’s dedication to endorsing safe and effective opioid alternatives for pain management.”
Clinical results also support Vertex’s breakthrough, as studies showcased that their painkiller outperformed a placebo in reducing pain intensity within 48 hours. These studies included over a thousand patients undergoing abdominoplasties (commonly referred to as “tummy tucks”) and additional procedures like bunion surgeries, both frequently used to study acute pain treatment.
However, when compared to an opioid mixture of hydrocodone—known for its potential for misuse—and acetaminophen, Journavx didn’t meet the secondary objective for pain reduction in these trials. But the good news came with fewer side effects observed in those taking Vertex’s medication compared to those on a placebo, with itching, muscle spasms, and skin rashes being the most prevalent side effects noted.
In yet another phase three trial, more than 83% of participants rated the drug as good to excellent in managing their pain, whether they’d undergone surgery or not.
Vertex could see an even greater breakthrough if it gains FDA approval for chronic pain treatment—a condition where long-term opioid use often poses higher addiction risks, as per the Centers for Disease Control and Prevention.
Earlier this year, Vertex achieved promising mid-stage trial results for its painkiller in patients with a chronic nerve disorder linked to diabetes. The company appears well-positioned to continue leading the charge in reshaping pain management.
