Vertex Pharmaceuticals Inc has gained US approval for the first new type of painkiller in more than two decades, paving the way for a safer alternative to addictive opioids that have been linked to hundreds of thousands of deaths.
Vertex’s pill, called Journavx, received US Food and Drug Administration clearance to treat moderate to severe acute pain, a statement said on Thursday. The wholesale acquisition cost for the twice-daily medicine is set at US$15.50 per 50 milligram tablet, Vertex said.
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 US deaths were linked to overdoses of the addictive drugs from 1999 to 2019, official figures show, with more than 70,000 in the year through June last year alone.
Photo:AP
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 is a key to Vertex’s strategy of diversifying beyond its core business centered on cystic fibrosis treatments.
While some analysts predict the painkiller would become a multibillion-dollar product for a company needing a growth driver, questions remain about its price and commercial potential. Health insurers and hospitals might continue steering patients to opioids, which — while dangerous — are cheap and effective.
Vertex has been pressing Congress to create policies that would 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 plans to focus on selling its drug to the about 2,000 US hospitals that see about two-thirds of patients in acute pain, chief operating officer Stuart Arbuckle said.
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 is already on the market to gain traction.
Vertex is studying the same pill to treat chronic pain lasting at least three months, which affects about 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.
OPTIMISTIC: A Philippine Air Force spokeswoman said the military believed the crew were safe and were hopeful that they and the jet would be recovered A Philippine Air Force FA-50 jet and its two-person crew are missing after flying in support of ground forces fighting communist rebels in the southern Mindanao region, a military official said yesterday. Philippine Air Force spokeswoman Colonel Consuelo Castillo said the jet was flying “over land” on the way to its target area when it went missing during a “tactical night operation in support of our ground troops.” While she declined to provide mission specifics, Philippine Army spokesman Colonel Louie Dema-ala confirmed that the missing FA-50 was part of a squadron sent “to provide air support” to troops fighting communist rebels in
PROBE: Last week, Romanian prosecutors launched a criminal investigation against presidential candidate Calin Georgescu accusing him of supporting fascist groups Tens of thousands of protesters gathered in Romania’s capital on Saturday in the latest anti-government demonstration by far-right groups after a top court canceled a presidential election in the EU country last year. Protesters converged in front of the government building in Bucharest, waving Romania’s tricolor flags and chanting slogans such as “down with the government” and “thieves.” Many expressed support for Calin Georgescu, who emerged as the frontrunner in December’s canceled election, and demanded they be resumed from the second round. George Simion, the leader of the far-right Alliance for the Unity of Romanians (AUR), which organized the protest,
ECONOMIC DISTORTION? The US commerce secretary’s remarks echoed Elon Musk’s arguments that spending by the government does not create value for the economy US Secretary of Commerce Howard Lutnick on Sunday said that government spending could be separated from GDP reports, in response to questions about whether the spending cuts pushed by Elon Musk’s Department of Government Efficiency could possibly cause an economic downturn. “You know that governments historically have messed with GDP,” Lutnick said on Fox News Channel’s Sunday Morning Futures. “They count government spending as part of GDP. So I’m going to separate those two and make it transparent.” Doing so could potentially complicate or distort a fundamental measure of the US economy’s health. Government spending is traditionally included in the GDP because
Hundreds of people in rainbow colors gathered on Saturday in South Africa’s tourist magnet Cape Town to honor the world’s first openly gay imam, who was killed last month. Muhsin Hendricks, who ran a mosque for marginalized Muslims, was shot dead last month near the southern city of Gqeberha. “I was heartbroken. I think it’s sad especially how far we’ve come, considering how progressive South Africa has been,” attendee Keisha Jensen said. Led by motorcycle riders, the mostly young crowd walked through the streets of the coastal city, some waving placards emblazoned with Hendricks’s image and reading: “#JUSTICEFORMUHSIN.” No arrest
RSS