An Effectiveness and Tolerability of Tapentadol Nasal Spray in Low Back Pain

Introduction: Low back pain (LBP) is one of the most prevalent musculoskeletal conditions, leading to significant disability and healthcare burden worldwide. Effective pain relief with minimal side effects is crucial for improving patient outcomes. Tapentadol, a dual-mechanism opioid with µ-opioid receptor agonism and norepinephrine reuptake inhibition, has shown potent analgesic effects. Intranasal administration is an emerging route that ensures rapid absorption and enhanced efficacy. However, limited real-world data exist on the clinical use of tapentadol nasal spray (NS) in LBP management. This study aimed to evaluate the effectiveness and tolerability of tapentadol NS in patients with LBP. Materials and Methods: This investigator-initiated, retrospective, real-world, observational study analyzed data from electronic medical records of adult LBP patients ≤65 years old treated with tapentadol NS for three consecutive days. The primary endpoint was change in score on the numeric pain rating scale (NPRS). The secondary endpoints were the proportion of patients requiring rescue medicine, change in global sleep quality score, and incidence of adverse events (AEs). Results: A total of 300 patients were included in the analysis. The mean ± standard deviation NPRS pain score decreased significantly from 7.00 ± 0.80 on day 0 to 1.38 ± 0.45 on day 3, reflecting an 80.29% reduction (P < 0.001 for all changes from baseline). Notably, 99.00% of patients achieved >51% pain reduction by day 3. Similar trends were observed across different age groups and between male and female patients. Only 1.67% (5/300) of patients required rescue medication (intravenous paracetamol). A significant improvement in sleep quality (P < 0.001) was also noted. Importantly, no AEs were reported, indicating excellent tolerability of tapentadol NS. Conclusion: Tapentadol NS demonstrated significant pain reduction and improvement in sleep quality in adult patients with LBP. The therapy was well tolerated, with no reported AEs and a minimal requirement for rescue medication. These findings suggest that tapentadol NS is an effective and safe treatment option for acute LBP. Future prospective studies with a longer follow-up period and a comparative analysis with other analgesic formulations are warranted to further establish its role in LBP management. Keywords: Tapentadol, low back pain, tapentadol nasal spray, pain reduction, sleep quality, tolerability.