4 hours Ago By MATTHEW PERRONE Associated Press
WASHINGTON — Federal officials approved a new type of pain drug Thursday designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin . The U.S.
Food and Drug Administration said it approved Vertex Pharmaceuticals' Journavx for short-term pain that often follows surgery or injuries. It's the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen. Still, the medication's modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage pain.
A tablet and bottle of the Journavx (suzetrigine) medication. Two studies in more than 870 patients with acute pain following foot and abdominal surgeries showed Vertex's pill provided more relief than a dummy pill but didn't outperform a common opioid-acetaminophen combination pill. "It's not a slam dunk on effectiveness," said Michael Schuh of the Mayo Clinic, a pharmacist and pain medicine expert who was not involved in the research.
"But it is a slam dunk in that it's a very different pathway and mechanism of action, so I think that shows a lot promise." Vertex began researching the drug in the 2000s, when drug overdoses were rocketing upward, principally driven by mass prescribing of opioid painkillers for common ailments like arthritis and back pain. Prescriptions fell sharply in the past decade and the current wave of the opioid crisis is mainly due to illicit fentanyl, not pharmaceutical medicines .
Opioids reduce pain by binding to receptors in the brain that receive nerve signals from different parts of the body. Those chemical interactions also give rise to opioids' addictive effects. Bankrupt Purdue Pharma LP and its owners have agreed to over $7 billion settlement to resolve lawsuits over OxyContin's role in the opioid epidemic.
The deal follows the U.S. Supreme Court’s rejection of a $6 billion agreement last year.
It requires Purdue to pay $900 million and the Sackler family to contribute $6.5 billion, though it does not guarantee protection from future lawsuits. Purdue declared bankruptcy in 2019, had previously pled guilty to federal felonies, and faced widespread litigation over its OxyContin marketing.
The Sackler family denies wrongdoing. Vertex's drug works differently, blocking proteins that trigger pain signals that are later sent to the brain. "In trying to develop medicines that don't have the addictive risks of opioid medicines, a key factor is working to block pain signaling before it gets to the brain," Vertex's Dr.
David Altshuler, told the Associated Press last year . Commonly reported side effects with the drug were nausea, constipation, itching, rash and headache. "The new medication has side effect profiles that are inherently, not only different, but don't involve the risk of substance abuse and other key side effects associated with opioids," said Dr.
Charles Argoff of the Albany Medical Center, who consulted for Vertex on the drug's development. The initial concept to focus on pain-signaling proteins came out of research involving people with a rare hereditary condition that causes insensitivity to pain. A tablet of the Journavx (suzetrigine) medication.
Vertex attracted interest from Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple drugs across several forms of chronic pain, which generally represents a bigger financial opportunity than acute pain. The Boston drugmaker's share price plummeted in December when Vertex reported disappointing mid-stage results in a study of patients with chronic nerve pain affecting the lower back and legs. The drug didn't perform significantly better than placebo, the research found.
"We believe the data reflect a near worst-case scenario for this key pipeline program," biotechnology analyst Brian Abrahams said in a research note to investors, adding that the results jeopardized estimates that Vertex's pipeline could be worth billions across multiple forms of pain. Still, Vertex executives said they plan to move forward with a new, late-stage study of the drug, theorizing that a different trial design could yield better results and pave the way for FDA approval in chronic pain. Drug overdoses are a leading cause of accidental death in the United States.
Among all overdose deaths, opioids were the culprit 70.6% of the time in 2019, according to the Centers for Disease Control. Nearly 30 years after the first wave of the opioid epidemic began, roughly 645,000 Americans have died from overdoses where prescription or illicit opioids were involved, according to the CDC.
Current estimates indicate that between 6.7 and 7.6 million Americans suffer from opioid use disorder.
Beginning in 2013, the introduction of synthetic opioids like fentanyl and xylazine into the drug supply sparked a surge in opioid overdose deaths. According to the Department of Health & Human Services Overdose Prevention Strategy, drug overdose deaths due to synthetic opioids besides methadone have increased an astounding 103-fold since 1999 and are the primary driver of overdose deaths. During an overdose, opioids bind to receptors in the brain that control respiratory function, leading to impaired breathing and amounting to brain damage and death due to lack of oxygen.
In recent years, drugs to treat substance use disorder and prevent overdose deaths have surged in usage. Naloxone, available as a nasal spray or injectable medication, can reverse opioid overdoses after they happen. The drug, often known by the brand name Narcan, was made available over the counter in 2023 in an effort by the Food and Drug Administration to increase accessibility.
Nearly 1.7 million prescriptions of naloxone were dispensed in 2022, up from 904,000 in 2019. Buprenorphine, however, must be prescribed by a health care provider as part of a long-term substance misuse treatment plan, often for those addicted to heroin, oxycodone, fentanyl, or other opiates.
Buprenorphine works by reducing withdrawal symptoms and curbing drug cravings. As a long-acting opioid, it takes more time to act on the body over a more extended period. Though it's classified as a Schedule III drug due to its addictive properties, at the correct dosage it helps give people suffering from addiction a level of stability by reducing the harms of illicit opioid misuse.
About 16 million buprenorphine prescriptions were dispensed in 2022, slightly higher than in 2019. However, as the epidemic retains its grip on the nation, medical professionals are prescribing opioids for pain relief with less frequency. The rate of opioid prescriptions for pain fell steadily between 2019 and 2022, from 46.
8 per 100 people in 2019 to 39.5 per 100 people in 2022. The prescription rate for opioid treatment drug buprenorphine, meanwhile, slightly increased over the same period from 4.
7 to 4.8 prescriptions per 100 people. Part of this increased access is due to the $50 billion opioid settlement fund distributed to each state for opioid harm reduction and treatment services.
Many states are in the process of determining how to deploy settlement funds; the level of access to lifesaving medications thus varies by state and their specific approach to combating the crisis. To compare how states are utilizing these funds, Ophelia used CDC data to map the growing distribution of common medications that prevent opioid overdoses and treat substance use disorders. Despite having the highest drug overdose death rate, West Virginia ranked 12th in naloxone prescriptions at 0.
7 per 100 people in 2022. However, the state saw the fifth-highest growth in naloxone prescriptions, growing from 0.3 per 100 people in 2019.
Arkansas dispensed the most naloxone prescriptions, perhaps contributing to its relatively low rate of drug overdose deaths at 21.7 per 100 people. Arkansas saw the biggest jump in naloxone prescriptions, increasing from 0.
1 prescriptions per 100 people in 2019 to 1.7 per 100 people in 2022. After Arkansas, the top states for growth in naloxone prescriptions were: - Kentucky (+0.
8 per 100 people) - South Carolina (+0.8) - Tennessee (+0.6) Access to naloxone grew in every state except New Mexico, where it shrank, and New Hampshire, where it stayed the same.
Overall, naloxone prescriptions per resident remain much lower than buprenorphine due in part to the different purposes each drug serves. Naloxone is used in emergencies and is not prescribed as a medication to take on a routine basis. In addition to over-the-counter purchases, the drug is distributed through public health programs and emergency care outside traditional prescription avenues.
Buprenorphine, on the other hand, is dispensed only by health care providers for long-term opioid use disorder treatment to ease withdrawal symptoms and cravings, often necessitating refills on a regular basis for complete treatment. Cost is also an issue. A two-dose packet of Narcan runs just under $50 at many drugstores, and like most over-the-counter drugs, insurance doesn't cover it.
While a lifesaving measure might seem worth the price tag, $50 is prohibitive for some. To help reach communities in need, there are several resources available for free naloxone supplies and emergency kits. Despite efforts to reduce the stigma around substance-related disorders, walking into a Walgreens or CVS and purchasing overdose medication might be challenging for those with OUD.
However, the use of lifesaving treatments is imperative as the opioid epidemic continues to take its toll. Obsolete and incorrect beliefs about the nature of addiction, which liken the disease to moral failure, can prevent people from seeking help and hinder the development of health and public policies. In contrast, a punitive approach to OUD can increase drug use by dehumanizing those who need help while failing to address the underlying cause of the disease.
Medication-based treatment has not been a first line of defense in treating opioid misuse disorder long-term. According to a study by the NIH and CDC, just over 1 in 5 adults with opioid use disorde r received medication-based treatment, namely buprenorphine, methadone, or naltrexone, in 2021. The study also found that Schedule III, II, and unscheduled drugs, respectively, were dispensed for substance use treatment 38 times more often when it was a telehealth appointment.
West Virginia leads in prescriptions per capita, which have increased by 4.4 prescriptions per 100 residents to reach 27.2—over a quarter of the state's total population.
Indiana, whose capital city is a national hotspot for opioid overdoses, saw the second-highest increase in buprenorphine prescriptions, reaching 10.7 per 100 residents in 2022. Despite having the second most overdoses due to opioids, the District of Columbia issued an average of 1.
5 fewer prescriptions per 100 people. Prescriptions fell the most in Vermont by 3.1 overall, dropping from 28.
6 per 100 people to 25.5 per 100 people. In 2021, the state became the first to decriminalize buprenorphine possession in limited quantities.
In a promising outlook for this harm reduction strategy, Vermont is experiencing a three-year low in opioid overdose rates based on 2024 data so far. Story editing by Alizah Salario. Additional editing by Kelly Glass.
Copy editing by Kristen Wegrzyn. This story originally appeared on Ophelia and was produced and distributed in partnership with Stacker Studio. The business news you need Get the latest local business news delivered FREE to your inbox weekly.
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