Vertex’s pill, called Journavx, gained Food and Drug Administration clearance to treat moderate-to-severe acute pain, according to a statement Thursday. The wholesale acquisition cost for the twice-daily medicine is set at $15.50 per 50-milligram tablet, Vertex said. Its shares rose 0.4% after U.S. markets closed.

Each year, about 125 million opioid prescriptions are written for Americans with pain caused by broken bones, burns, surgeries, and other injuries and procedures. More than half a million U.S. deaths were linked to overdoses of the addictive drugs from 1999 through 2019, according to government figures, with more than 70,000 in the year through June 2024 alone. While some fatalities involved use of illicit drugs, many people begin taking them after they lost access to prescribed opioids, leading doctors and health officials to look for other options. 

Vertex’s drug has been hailed as a scientific breakthrough because it allays pain without entering the brain, minimizing the risk of addiction and dependence that can lead patients to ramp up doses to dangerous levels. It’s a key to Vertex’s strategy of diversifying beyond its core business centered on cystic fibrosis treatments. 

While some analysts predict the painkiller will become a multibillion-dollar product for a company needing a growth driver, questions remain about its price and commercial potential. Health insurers and hospitals may continue steering patients to opioids, which—while dangerous—are cheap and effective. 

Vertex has been pressing Congress to create policies that will help its product succeed. For example, the No Pain Act, which provides extra Medicare reimbursement to hospitals that prescribe alternatives to opioids, went into effect this year. The company will focus on selling its drug to the roughly 2,000 U.S. hospitals that see about two-thirds of patients in acute pain, according to COO Stuart Arbuckle.

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Trial setbacks

Boston-based Vertex, the maker of cystic fibrosis treatments like the blockbuster Trikafta, has worked for more than two decades to develop a nonaddictive pain drug. Journavx, also called suzetrigine, blocks a structure in the nerve cells that send pain signals to the brain. 

In late-stage studies of patients with acute pain after surgery, Vertex’s drug worked better than a placebo but failed to reduce pain faster than a combination of acetaminophen, better known as Tylenol, and an opioid. That could present a challenge for Vertex, as new drugs typically must outperform what’s already on the market to gain traction.

Vertex is studying the same pill to treat chronic pain lasting at least three months, which affects some 50 million Americans. The company encountered a setback in December when a mid-stage trial showed the drug failed to work better than a placebo in lower back pain, causing the shares to plunge.

For more on pain management:

• Doctors are prescribing the trendy, mind-altering drug ketamine for hard-to-treat pain. Experts worry the U.S. may be repeating mistakes that gave rise to the opioid crisis
• Purdue Pharma and Sackler family to pay $7.4 billion in revised settlement of lawsuits over OxyContin opioid toll
• Researchers may have discovered a breakthrough vaccine for fentanyl—the drug at the center of the opioid crisis
• Walgreens accused of filling millions of illegitimate prescriptions, including for opioids
• Ozempic may help manage opioid addiction: study