Breakthrough Clinical Results
Vertex Pharmaceuticals announced that its non-opioid pain medication, JOURNAVX™ (suzetrigine), has been recognized as a groundbreaking healthcare technology by Premier, Inc. JOURNAVX is a first-in-class, oral, highly selective NaV1.8 pain signal inhibitor approved by the FDA for treating moderate-to-severe acute pain in adults. This award highlights JOURNAVX's innovative approach to pain management, offering an alternative to opioid-based treatments. Vertex and Premier have a group purchasing agreement to ensure broad access to JOURNAVX for patients and healthcare providers.
Key Highlights
- JOURNAVX™ (suzetrigine) wins Premier, Inc.'s Breakthroughs Innovation Celebration award.
- JOURNAVX is a first-in-class, non-opioid treatment for moderate-to-severe acute pain.
- The FDA approved JOURNAVX for twice-daily use in adults.
- A national group purchasing agreement with Premier ensures broad access to JOURNAVX.
Incidence and Prevalence
Global Epidemiology of Acute Pain: Current Evidence
After thorough examination of the available literature, there appears to be a significant gap in comprehensive global data specifically addressing the worldwide incidence and prevalence of acute pain. While numerous studies have investigated various pain conditions, the current evidence base lacks specific global statistics for acute pain epidemiology.
Regional Pain Prevalence Data
Some regional data provides partial insights into pain prevalence:
- In Israel, a cross-sectional population survey of 2,210 adults found that 44% reported pain on the day of the interview
- The prevalence of chronic widespread pain in the Israeli adult population was estimated at 10.2% after adjusting for sex and age (with rates of 14% in women and 3% in men)
COVID-19 Related Pain Data
Recent studies have documented pain prevalence in COVID-19 patients:
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A 2021 study found pain symptoms were reported by 61.54% of hospitalized COVID-19 patients, with most common symptoms being:
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Generalized myalgia (32.96%)
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Headache (27.47%)
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Low back pain (22.53%)
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A 2022 study found COVID-19 was associated with a significantly higher prevalence of:
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De novo pain (65.2% vs. 11.0% in controls)
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De novo chronic pain (19.6% vs. 1.4% in controls)
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Another 2022 study of COVID-19 survivors found:
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50.8% reported new-onset pain
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38.5% reported clinically significant pain
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A separate 2022 study estimated the prevalence of chronic pain in COVID-19 survivors to be 63.3%, with the most common sites being:
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Low back (37.8%)
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Joints (28.9%)
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Neck (12.2%)
Cancer-Related Pain Data
Pain prevalence in cancer patients has been documented:
- A 2017 study found pain prevalence rate was 48.5% in cancer patients, with three quarters of patients in pain having chronic background pain, moderate to severe
- A 2009 study of cancer patients with breakthrough pain found that minorities reported significantly greater severity for consistent pain and breakthrough pain compared to white patients
Demographic Variations
Several demographic factors influence pain prevalence:
- Gender differences were noted in multiple studies, with women generally reporting higher rates of pain than men
- Age was also a factor, with one study noting that the prevalence of any chronic pain (regional or widespread) increased with age
The available literature does not provide sufficient information specifically addressing methodological approaches used in recent research to quantify the worldwide burden of acute pain syndromes.
Economic Burden
Economic Burden of Acute Pain Treatment: Recent Estimates from USA and Europe
Recent Cost Estimates
The most recent data from 2022 shows that for Chinese cancer patients with breakthrough cancer pain (BTcP), the total cost per patient was 2941.60 euros per month. This cost breaks down as: - 88% direct medical costs - 5% non-medical direct costs - 7% indirect costs due to lost productivity
A 2014 study examining neuropathic pain in US adults found that after adjusting for demographic and clinical variables, total mean annualized costs per subject were: - Direct medical costs to payers: US$6,016 (95% CI 5,316-6,716) - Direct costs to subjects: US$2,219 (95% CI 1,919-2,519) - Indirect costs: US$19,000 (95% CI 17,197-20,802)
This study also determined that indirect costs were the primary cost driver at all pain severity levels, with significant differences across pain severity levels.
Cancer-Related Pain Costs
A 2003 study of cancer-related pain found that 76% of patients experienced at least one pain-related cost, resulting in an average monthly direct cost of US$891 per patient.
In the same study, 69% of patients experienced direct medical costs due to pain, averaging US$825/month per patient, while 57% reported indirect pain-related expenses averaging US$61/month per patient.
Higher pain intensity, greater pain interference, and presence of breakthrough pain were identified as predictors of higher direct and indirect medical expenses.
Treatment-Specific Cost Analyses
A 2002 study comparing intrathecal drug therapy (IDT) with conventional pain therapy (CPT) for chronic low back pain found that the cumulative costs for IDT during a 5-year period were $29,410, compared to $38,000 for CPT. The high initial costs of equipment required for IDT were recovered by 28 months, after which CPT became the more expensive treatment option.
From a 2022 study on methadone for refractory cancer pain, the median daily cost of analgesic regimens was $19.5 (IQR: 12.3-46.2) before switching to methadone and $10.8 (IQR: 7.1-18.7) after switching.
A 2024 study on intrathecal drug delivery systems (IDDS) for cancer pain reported that double-catheter IDDS had higher cumulative hospitalization expenses, IDDS opioid costs per month, and refill costs compared to single-catheter IDDS. However, monthly oral opioid costs and total costs of analgesic were significantly lower with double-catheter IDDS. Despite higher initial costs, double-catheter IDDS demonstrated superior long-term pain control, reduced incidence of breakthrough pain, and lower overall monthly analgesic costs.
Recent Intervention Studies
A 2023 Australian study of an intensive pain management program showed improved health outcomes, reduced healthcare services' cost, and reduced number of medications taken 1 month after participation.
A 2022 study on Guanxin Shutong Capsules (GSC) for coronary heart disease angina pectoris found that it was more economical for patients to use GSC combined with conventional treatment than conventional treatment alone, based on the assumption that the per capita disposable income in 2020 is the willingness-to-pay threshold.
Economic Burden by Pain Severity
The economic burden of pain, particularly indirect costs, was highest among those with severe pain and higher than previously reported in studies of specific neuropathic pain conditions.
A 2016 study on noncancer pain in outpatient settings showed that pain had a significant negative impact on physical and mental health-related quality of life, which correlates with increased economic burden.
Drug used in other indications
JOURNAVX (Suzetrigine) Clinical Trials Beyond Acute Pain
Based on a thorough review of the available information, there is no data regarding clinical trials of JOURNAVX (suzetrigine) for indications beyond acute pain. The only reference to suzetrigine in the available information identifies it as VX-548 in the context of emerging therapeutic agents for acute pain treatment, as mentioned in a 2023 source.
No information is available about: - Clinical trials for non-acute pain indications - Intervention models for such trials - Dosing regimens or study designs - Mechanism of action for non-pain indications
The limited information only establishes suzetrigine as one of several emerging therapeutic agents being developed for acute pain management, alongside other compounds such as Cebranopadol, AAT-076, Combogesic intravenous, sublingual ketamine, XG004, and HTX-011 (Zynrelef).