
The study described is a phase 2, double-blind, placebo-controlled trial that investigates the efficacy and safety of oral difelikefalin, a selective kappa opioid receptor agonist, in the treatment of notalgia paresthetica. The study's primary outcome was the change in the weekly mean score on the Worst Itch Numeric Rating Scale (WI-NRS) at week 8. The results showed that the difelikefalin group had a greater reduction in itch intensity scores compared to the placebo group, with a difference in change of −1.6 points. However, the secondary outcomes did not support the primary analysis results, and the difelikefalin group experienced more adverse events, such as headache, dizziness, constipation, and increased urine output, compared to the placebo group. The study concludes that further larger and longer trials are needed to fully assess the efficacy and safety of difelikefalin treatment in notalgia paresthetica.
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