Rapid Reduction and Free or Almost Free of Itch Response With Oral Difelikefalin in Subjects With Notalgia Paresthetica and Moderate-to-Severe Pruritus
Year: 2024
Type: article
Study design: Clinical Trial
Abstract: Notalgia paresthetica (NP) is a common neuropathic itch characterized by pruritus of the upper back 1• This phase 2, multicenter, randomized, double-blind study was conducted in subjects with NP and moderate-to-severe pruritus who were randomized to oral difelikefalin (DFK, 2 mg), a kappa-opioid receptor agonist, or placebo twice daily for 8 weeks • Of the 126 subjects included in this analysis, strict complete response rates (100% of daily Worst Itch Numeric Rating Scale [WI-NRS] scores equal to 0 or 1 during the week) were significantly greater in subjects treated with DFK (14%) versus placebo (1%) as early as week 3 (P=0.045)and were maintained through week 8 (25% vs 4%; P=0.006)• Individual WI-NRS scores demonstrated rapid onset of DFK efficacy, which was maintained through week 8• In subjects with NP, 8 weeks of treatment with DFK led to rapid improvement in itch intensity• These findings support the role of kappa-opioid receptor activation to control neuropathic itch
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4390904749