Positive results for oral difelikefalin in Phase 2 nostalgia paresthetica study

NEJM has published positive results from the KOMFORT Phase 2 trial of oral difelikefalin for nostalgia paresthetica, a condition involving itching, burning or tingly sensations on the back.

Cara Therapeutics (Nasdaq:CARA) is the developer of the drug, which won FDA approval in an injectable form for moderate-to-severe pruritus in hemodialysis patients in 2021. That form of the drug has the trade name Korsuva. Difelikefalin is a selective kappa-opioid receptor agonist.

The company’s stock dipped about 2% to $11.67 after the company announced the data.

Drug appeared effective but associated with adverse events

The KOMFORT study’s primary endpoint was a change in the weekly mean of the 24-hour Worst Itch Numeric Rating Scale (WI-NRS) score. At 8 weeks, more patients achieved an at least 4-point improvement with oral difelikefalin than with placebo.

The study recruited 126 patients total.

The NEJM article noted that, while the drug supported mo…

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