Vertex Pharmaceuticals' suzetrigine is seeking FDA approval for short-term pain relief. If successful, the drug could be a game-changer for managing pain without the risks associated with opioids.
The long quest for powerful non-opioid drugs that treat pain without risk of addiction is nearing a milestone, in the form of a pill that could soon win approval from the Food and Drug Administration. If successful, the drug developed by Vertex Pharmaceuticals would offer a possible alternative to potent prescription painkillers such as oxycodone, which was once heavily marketed by drug companies and fueled an epidemic of dependency and death.
Independent experts say it remains too early to know how revolutionary the Vertex drug, suzetrigine, will be. The company’s application that is pending before the FDA, which could be approved by the end of January, is for relatively short-term pain. It is based on successful clinical trials in people recovering from two types of surgeries, as well as a safety study that monitored participants over about six weeks. Vertex is still exploring whether the drug can be safely and effectively used for chronic, longer-lasting pain. Researchers point out that the trials to date have been too short to gauge the safety of taking the drug for an extended time, and that harmful side effects from a first-of-its-kind drug can emerge even after rigorous review by the FDA. Some are skeptical of suzetrigine’s addiction-free potential, with the memory still fresh of pharmaceutical companies downplaying the risks of opioids and aggressively marketing them to doctors in the late 1990s and 2000s. A closely watched trial measuring suzetrigine’s effect on sciatica failed to show a meaningful improvement over placebo, deflating analysts’ hopes that the experimental drug could be a breakthrough treatment for a common form of chronic pain.The experience of pain begins in a nerve ending, like stubbing a toe, as the body detects the pressure and sends a signal to the spinal cord and then the brain. An opioid acts directly on the brain to block pain, often producing a kind of euphoria that feeds addiction. By contrast, suzetrigine works by closing down the gateway that the pain signal travels through before it reaches the spinal cord. “There’s no indicator of any other feelings than just the pain going down,” Paul Negulescu, a senior vice president at Boston-based Vertex, said of suzetrigine in an interview last fall. Though Vertex collects “spontaneous reports” of what patients feel when taking the drug, it has only measured their level of pain rather than the subjective experience of it. Still, based on the trial data and how suzetrigine works, Negulescu said: “We believe there’s no addiction potential.” Vertex estimates that 80 million adults in the United States receive prescription medication for short-term pain - also known as acute pain - every year. If the company does eventually win approval for longer-term pain, financial analysts say, the company’s portfolio of painkillers in development could bring in multibillion-dollar annual sales within a decade. “The market opportunity is much bigger than people realize,” said David Risinger, an analyst at the investment bank Leerink Partners, likening the demand for effective painkillers to treatments for obesity. He added, “The number of people in the country that are in desperate need of better medicine is extraordinary.” Vertex hasn’t disclosed a price for suzetrigine, but it is virtually certain to cost more than generic opioids. If approved, it would be among treatments covered under a federal law that expands coverage of non-opioids after surgeries. It is an exciting prospect for people with chronic pain such as Kim Juroviesky, who has complex regional pain syndrome and fibromyalgia. When the nerve pain in her leg has flared up, she said, “I couldn’t have a blanket touch me at night.” “We’ve waited how many years for a new type of pain medication?” said Juroviesky, a retired nurse practitioner and Air Force veteran who has found some relief through infusions of the anesthetic ketamine. Still, she is cautious. “Usually when new drugs come out I don’t want to be the first one taking it,” she said.The United States remains mired in a staggering overdose crisis that in 2023 killed more than 100,000 people for the third year in a row, although officials are buoyed by a sharp decline in deaths during the past year. Many users later turned to heroin and now illicit fentanyl, which became the leading killer in the United States of people between the ages of 18 and 49. Officials have tightened access to opioids, cracked down on companies that failed to flag suspicious orders, and revamped guidelines for prescribing them. While opioid prescriptions have plummeted, many chronic pain patients bristle at what they say are onerous restrictions on desperately needed medications. Pain relievers such as acetaminophen and ibuprofen are common but not as effective as opioids
PAIN MANAGEMENT NON-OPIOID DRUGS FDA APPROVAL SUZETRIGINE VERTEX PHARMACEUTICALS ADDICTION OPIOIDS OVERDOSE CRISIS
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