FDA approves Vertex non-opioid painkiller drug Journavx

The Food and Drug Administration on Thursday approved Vertex Pharmaceuticals’ non-opioid painkiller pill, a new alternative for pain relief that comes without the risk of addiction. 

Vertex is now the first drugmaker in decades to gain U.S. approval for a new type of pain medicine. It’s a milestone after a long history of mostly unsuccessful efforts to develop painkillers without the destructive dependency of cheap and widely available opioids, which have caused a horrific epidemic of abuse and overdose in the U.S.

Vertex’s drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely eases with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., according to Vertex. 

Almost 10% of patients with acute pain who are treated initially with an opioid will go on to have prolonged opioid use, and roughly 85,000 people will develop opioid use disorder annually, Vertex said in a statement.

“We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,” Dr. Reshma Kewalramani, Vertex CEO, said in a statement.

Vertex said Journavx will have a list price of $15.50 per 50-milligram pill. Wall Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion. 

The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex’s treatment works by blocking pain signals at their origin before they reach the brain. That’s different from opioids, which act directly on the brain to block pain, triggering the brain’s rewards centers in a way that can feed addiction.

The approval underscores the “FDA’s commitment to approving safe and effective alternatives to opioids for pain management,” said Dr. Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, in a release.

Vertex’s painkiller was more effective than placebo at reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as “tummy tucks,” and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.

The painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for popular pain medications such as Tylenol.

In both trials, rates of adverse side effects were lower in those who received Vertex’s drug compared to people who took a placebo. The most commonly reported adverse events among people who received Journavx were itching, muscle spasms and rash, among others, according to the FDA.

In a separate phase three study, more than 83% of patients said in a survey that the drug was good, very good or excellent at easing pain. Those people had undergone various surgical or non-surgical procedures.

The bigger opportunity for Vertex may be to win FDA approval in chronic pain. That’s an area where the risk of addiction to prescription opioids can be greater, according to the Centers for Disease Control and Prevention. 

In 2023, the company’s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition.