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ACD440 gel reduces heat-evoked pain in chronic neuropathic patients and specifically affects C-fibre mediated pain without impacting Aβ and Aδ pathways.
A phase 2a study by Adriana Miclescu et al. tested a topical transient receptor potential cation channel subfamily V1 (TRPV1) antagonist (ACD440 gel) for its effects on stimulated pain and safety in patients with chronic peripheral neuropathic pain (PNP), targeting the receptor implicated in pain transmission.
This exploratory, randomized crossover trial included patients with chronic PNP and sensory hypersensitivity. Volunteers had postherpetic neuralgia, postoperative neuropathic pain, or chemotherapy-induced neuropathic pain. The selected subjects applied ACD440 gel twice daily to the affected areas for 7 days. The evoked pain responses to brush, cold, heat, and pinprick were primary endpoints, while spontaneous pain and the neuropathic pain symptom inventory (NPSI) were secondary endpoints. A post hoc analysis of the first treatment period was conducted due to a significant period effect, enabling a parallel group comparison.
Results indicated that fourteen patients completed the study, and ACD440 gel markedly decreased heat-evoked pain in heat-hyperalgesic patients, with median scores dropping from 6 (inter quartile range [IQR] 4.75–7.75) to 1.5 (IQR 0.75–2.25), while placebo showed a slight elevation from 4 (IQR 3.5–5.0) to 5.0 (IQR 4.5–6.5) (p = 0.029). The treatment was well-tolerated, with no adverse events reported. Responses to mechanical hyperalgesia and brush allodynia remained largely unchanged (p = 0.07), indicating a selective effect on thermally induced pain.
ACD440 gel successfully reduced thermally evoked pain, particularly in suprathreshold heat stimuli. The reduction was specific to C-fibre mediated pain, with no noticeable impact on Aβ or Aδ fibre responses. These results indicate potential for further clinical development in tackling chronic neuropathic pain driven by thermal sensitivity.
Scandinavian Journal of Pain
Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces temperature-evoked pain in patients with peripheral neuropathic pain with sensory hypersensitivity, a randomized, double-blind, placebo-controlled, crossover study
Adriana Miclescu et al.
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