Capsaicin patch for diabetic peripheral neuropathic pain

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Capsaicin patch for diabetic peripheral neuropathic pain

Peripheral neuropathic pain is caused due to damage or injury to the peripheral somatosensory nervous system. Nerve damage can be linked to various underlying medical conditions, different diseases, or traumatic injuries that causes tingling, numbness, unusual sensations, weakness, or burning pain in the affected area. The current recent study was carried out to evaluate the long-term safety and tolerability of capsaicin 8%  patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy (PDPN).

This was a phase III, multinational, randomized, controlled, 52-week study, which included 468 patients with a confirmed diagnosis of PDPN associated with type 1 or type 2 diabetes mellitus for ≥1year prior to the screening visit. Patients either received capsaicin 8% patch repeat treatment plus standard of care (SOC) to painful areas of the feet for 30 min plus SOC, for 60 min plus SOC, or SOC alone. All patients were pretreated with a eutectic mixture of local anaesthetics (EMLA) containing lidocaine 2.5% and prilocaine 2.5%, to comfort the patienrs during the application period.

The primary aim of the study was to find out percentage change in average daily pain score from baseline between 2- 8 weeks. Secondary objective was to calculate weekly average daily pain, 30% responder rates, BPI-DN sleep interference score, and weekly sleep interference score. The mean number of patches used were same for capsaicin groups (30 min, 1.53; 60 min, 1.42) and the mean duration of patch application was 30.2 min in the 30-min group and 60.2 min in the 60-min group. More than half of patients in the capsaicin 8% patch groups received the maximum seven capsaicin treatments.

Mean changes in Norfolk QOL-DN total score from baseline [estimated mean difference versus SOC alone; 90% CI for difference] were: 30 min plus SOC, −27.6% [−20.9; −31.7, −10.1]; 60 min plus SOC, −32.8% [−26.1; −36.8, −15.4]; SOC alone, −6.7%. Mean changes [difference versus SOC alone] in UENS total score by EoS versus baseline were: 30 min plus SOC, −2.1 [−0.9; −1.8, 0.1]; 60min plus SOC, −3.0 [−1.7; −2.7, −0.8]; SOC alone, −1.2. No indications of deterioration were observed.

After 52 weeks, repeat treatment with the capsaicin 8% patch plus SOC versus SOC alone in  PDPN patients was found to be well tolerated and consistent with the established safety profile of the capsaicin 8% patch. Capsaicin plus SOC had no negative functional or neurologic effects compared with SOC alone. Thus, this study extends the range of peripheral neuropathic pain treatment for which the capsaicin 8% patch has shown both tolerability and safety.


BMC neurology

Link to the source:

Original title of article:

Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study

BMC neurology
Therapeutic, Capsaicin, Diabetic Peripheral Neuropathy, Nerves, Alkylamide, Phase 3, Multinational, Open-label, Randomised, Controlled Study, Safety, Tolerability, QOL-DN score, UENS
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