September 21, 2015
Patients with diabetic peripheral neuropathy who used a capsaicin 8% patch (Qutenza, Astellas Pharma) had more relief from pain and better sleep quality than those who received a placebo patch, according to a phase 3 study reported at the European Association for the Study of Diabetes (EASD) 2015 Meeting.
The results were presented as the company announced the patch has just been approved in Europe for the additional indication of the treatment of adult diabetes patients with peripheral neuropathic pain, either alone or in combination with other medicinal products for pain.
The capsaicin patch is already approved for use in the European Union for neuropathic pain, but that license excluded patients with diabetes. Similarly, in the United States, the capsaicin patch 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 assessed the efficacy and safety of the patch, a dermal delivery system containing 8% capsaicin, vs placebo, following patients for 12 weeks
“We found that capsaicin 8% patch provides a statistically significant improvement in pain relief and sleep quality compared with placebo in these patients,” said Dr Stoker. The capsaicin patch “was well-tolerated, and safety was consistent with previous studies in postherpetic neuralgia and HIV-associated neuropathy.”
“The most commonly reported treatment-emergent adverse events were burning sensation [14% capsaicin, 2.7% placebo]; unsurprisingly, pain in extremity [10.8% vs 5.5%]; and application-site pain. There were no serious adverse events or deaths in either group,” Dr Stoker reported.
In conclusion, he added that the study extends the range of peripheral neuropathic pain etiologies for which the capsaicin 8% patch shows efficacy and safety.