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.
Seven people sustained mostly minor injuries in an airplane fire in South Korea, authorities said yesterday, with local media suggesting the blaze might have been caused by a portable battery stored in the overhead bin. The Air Busan plane, an Airbus A321, was set to fly to Hong Kong from Gimhae International Airport in southeastern Busan, but caught fire in the rear section on Tuesday night, the South Korean Ministry of Land, Infrastructure and Transport said. A total of 169 passengers and seven flight attendants and staff were evacuated down inflatable slides, it said. Authorities initially reported three injuries, but revised the number
‘BALD-FACED LIE’: The woman is accused of administering non-prescribed drugs to the one-year-old and filmed the toddler’s distress to solicit donations online A social media influencer accused of filming the torture of her baby to gain money allegedly manufactured symptoms causing the toddler to have brain surgery, a magistrate has heard. The 34-year-old Queensland woman is charged with torturing an infant and posting videos of the little girl online to build a social media following and solicit donations. A decision on her bail application in a Brisbane court was yesterday postponed after the magistrate opted to take more time before making a decision in an effort “not to be overwhelmed” by the nature of allegations “so offensive to right-thinking people.” The Sunshine Coast woman —
BORDER SERVICES: With the US-funded International Rescue Committee telling clinics to shut by tomorrow, Burmese refugees face sudden discharge from Thai hospitals Healthcare centers serving tens of thousands of refugees on the Thai-Myanmar border have been ordered shut after US President Donald Trump froze most foreign aid last week, forcing Thai officials to transport the sickest patients to other facilities. The International Rescue Committee (IRC), which funds the clinics with US support, told the facilities to shut by tomorrow, a local official and two camp committee members said. The IRC did not respond to a request for comment. Trump last week paused development assistance from the US Agency for International Development for 90 days to assess compatibility with his “America First” policy. The freeze has thrown
TESTING BAN: Satellite photos show a facility in the Chinese city of Mianyang that could aid nuclear weapons design and power generation, a US researcher said China appears to be building a large laser-ignited fusion research center in the southwestern city of Mianyang, experts at two analytical organizations said, a development that could aid nuclear weapons design and work exploring power generation. Satellite photos show four outlying “arms” that would house laser bays, and a central experiment bay that would hold a target chamber containing hydrogen isotopes the powerful lasers would fuse together, producing energy, said Decker Eveleth, a researcher at US-based independent research organization CNA Corp. It is a similar layout to the US$3.5 billion US National Ignition Facility (NIF) in northern California, which in 2022 generated
RSS