Results of a phase 3 study presented last month at the European Association for the Study of Diabetes (EASD) 2015 Meeting in Stockholm found that patients with diabetic peripheral neuropathy who received a capsaicin 8% patch experienced more complete pain relief and better sleep quality than those who received a placebo patch. The study was supported by Astellas Pharma Europe, which also announced at the meeting that the patch had received approval in the European Union for the additional indication of the treatment of adult diabetes patients with peripheral neuropathic pain, either alone or in combination with other pain treatments.
The capsaicin patch had previously been approved for use in the EU for neuropathic pain, and in the United States is approved for the treatment of postherpetic neuralgia, but this label doesn't include diabetes patients. At the EASD meeting, Malcolm Stoker, PhD, global medical lead at Astellas Pharma Global Development, the Netherlands, presented the findings of the randomized, placebo-controlled, double-blind STEP trial involving 369 participants to gauge the efficacy and safety of the patch, a dermal delivery system containing 8% capsaicin, vs placebo, following patients for 12 weeks. According to Dr. Stoker, the study found that the cohort receiving the capsaicin 8% patch reported a statistically significant improvement in pain relief and sleep quality compared with the cohort receiving a placebo patch, and that the capsaicin patch “was well-tolerated, and safety was consistent with previous studies in postherpetic neuralgia and HIV-associated neuropathy.”
To read more about techniques to combat DPN, click here.
To view a slide presentation on DPN, click here.
A news story about the above study findings, with reference to additional information from the presentation, may be read here.