Opioids are substances that work by activating receptors on nerve cells to reduce pain intensity. They are prescribed for treating acute and chronic pain. Long-term use carries the risk of tolerance and addiction.
Widespread misuse of prescription and illegal opioids led the U.S. Department of Health and Human Services to declare a public health emergency in 2017. A strategy was announced to address this crisis. However, opioid use disorder and addiction are still serious problems. In addition to addressing the chronic pain that opioids are prescribed to treat, these potent medications are associated with a significant number of side effects and complications, including sedation, dizziness, nausea, and physical dependence.
Because your workforce may include employees with conditions that lead to painful symptoms that impact their quality of life both at home and at work, it’s important understand prevelence and treatment options. Per the Food and Drug Administration (FDA), as we confront opioid abuse and addiction, we must also take steps to help those with acute and chronic pain who need access to medicines, including opioids, get improved treatment alternatives.
Guidelines and market trends
The Centers for Disease Control and Prevention (CDC) issued guidelines in 2022 that recommend nonopioid medication, both prescription and non-prescription (e.g., NSAIDs), for many types of acute pain because nonopioid therapies are considered at least as effective as opioids.
The nonopioid pain market is expected to grow as pharmaceutical companies hope to address the opioid crisis. According to a recent report, the global market is anticipated to increase from $78.89 billion in 2024 to $140.56 billion by 2031.
Suzetrigine – in the late-stage pipeline
Researchers are looking for less addictive and safer alternatives to help address the opioid crisis. Vertex Pharmaceuticals is a frontrunner with their novel, nonopioid product suzetrigine (formerly known as VX-548). It is an oral selective NaV1.8 pain signal inhibitor that aims to provide pain relief without the addictive potential of opioids.
Vertex recently announced positive phase 3 trial results. Suzetrigine achieved statistically significant improvements on pain primary endpoints compared to placebo in two phase 3 trials evaluating moderate-to-severe acute pain after surgery. These trials also looked at a secondary endpoint to compare the efficacy of suzetrigine to Vicodin® (hydrocodone bitartrate/acetaminophen). Neither trial met this endpoint. The majority of adverse events were mild to moderate, and there were no serious adverse events related to the study drug. Suzetrigine has been evaluated in a separate single-arm trial across a wide range of surgical and non-surgical pain conditions with results suggesting safety and effectiveness in treating pain.
Vertex has submitted a New Drug Application (NDA) for suzetrigine for the treatment of moderate-to-severe acute pain, and a decision from the Food and Drug Administration (FDA) is expected in late 2024/early 2025. It's in phase 3 development for the treatment of pain associated with diabetic peripheral neuropathy (DPN), with a trial expected to begin in the second half of 2024. In addition, a phase 2 trial is enrolling in lumbosacral radiculopathy.
Other nonopioids in development
Vertex is working on additional oral and injectable drugs in the same class as suzetrigine as well as NaV1.7 pain signal inhibitors for use alone or in combination. Other companies are also attempting to develop nonopioid NaV1.7 and NaV1.8. options for acute and chronic pain treatment. These agents are in earlier development and may have advantages over suzetrigine including better selectivity leading to improved safety. In addition, some companies are working on improved nonsteroidal anti-inflammatory drugs (NSAIDs) with better safety and tolerability.
What’s next – CarelonRx perspective
Currently, there are many opioid and anti-inflammatory options for the treatment of acute and chronic pain. While suzetrigine appears safe and effective compared to placebo, there is not enough evidence to determine how it compares to opioids. Early data versus Vicodin did not show comparable efficacy. The price has not been announced; however, it will likely be more than generic opioid products. Interest in finding alternative pain treatments is high due to the need to address the opioid crisis.
* Projections on future drug approvals and availability are based on information available at the time of publication and are not within the control of CarelonRx. Unless otherwise noted, information contained in this article was obtained from the Centers for Disease Control and Prevention (CDC) (cdc.gov), the Food and Drug Administration (FDA) (fda.gov), clinicaltrials.gov, releases from pharmaceutical manufacturers, National Institutes of Health (NIH) (nih.gov), and UpToDate.com (registration required). Information in this article is accurate as of July 15, 2024.
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