Reply to ‘Mirogabalin: Promising Evidence, Uncertain Access’

We sincerely thank Dr. Antonio Alcántara Montero for his insightful and constructive commentary on our recent article, ‘Mirogabalin for Treatment of Neuropathic Pain and Associated Sleep Interference: An Updated Meta-Analysis’ (João et al. 2025). Expanding this discussion is essential, as it helps situate emerging evidence within the broader clinical and regulatory contexts that underpin global access to neuropathic pain treatments (Alcántara Montero 2025). We agree that mirogabalin is a novel therapeutic option whose clinical impact remains possibly conditioned by regulatory and geographical factors. The predominance of Asian populations in pivotal trials indeed limits the generalisability of findings to other regions (Sumitani et al. 2025; Yang et al. 2024). Additional randomised and pragmatic studies across diverse ethnic and clinical backgrounds will be paramount to confirm its efficacy and tolerability beyond the original development settings. From a broader geographical perspective, as clinicians and researchers currently practicing in Latin America, we face the ongoing challenge of applying evidence largely derived from studies conducted in other regions, often under distinct clinical, cultural, and healthcare realities. These factors may, in turn, influence therapeutic response and real-world outcomes. In this regard, it is important to note that, even for classical gabapentinoids such as pregabalin and gabapentin, low- and middle-income countries' participation in high-quality randomised controlled trials has historically been underrepresented (Meaadi et al. 2023). Therefore, expanding multicentric collaborations would strengthen the external validity of future clinical trials in pain medicine and help ensure that therapeutic advances benefit patients worldwide. Moreover, discontinuation of neuropathic pain therapy in resource-constrained environments is frequently driven by medication cost, limited availability, and fragmented follow-up care (Khoiry et al. 2023; Machado-Duque et al. 2020; de Moraes Vieira et al. 2012). Adherence assessment is additionally limited by suboptimal cross-cultural validation and internal consistency (Khoiry et al. 2023). Addressing these gaps warrants coordinated multinational research efforts to map adherence determinants in socioeconomically heterogeneous populations. These barriers are especially pertinent as newer agents such as mirogabalin transition from trials to real-world care, where global implementation strategies may ultimately determine their practical impact. We appreciate the opportunity provided by the European Journal of Pain and its editorial board to publish our work and to extend this discussion beyond its original regional context, contributing to a more globally informed understanding of neuropathic pain management. The authors declare no conflicts of interest. This article is linked to https://doi.org/10.1002/ejp.70112 and https://doi.org/10.1002/ejp.70148.