Oral difelikefalin shows benefits in patients with CKD-related pruritus
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Cara Therapeutics recently announced phase 2 trial results that demonstrated its oral form of difelikefalin safely reduced itch intensity for patients with chronic kidney disease.
“These exciting results underscore oral Korsuva’s potential to be the first approved therapy in the U.S. for CKD patients suffering from moderate to severe pruritus,” Gil Yosipovitch, MD, professor in the Dr. Phillip Frost department of dermatology and cutaneous surgery and director of the Miami Itch Center, said in a press release. “There is an unmet medical need for an effective long-term therapy for treating intractable pruritus and the results from this trial suggest oral Korsuva holds great promise for CKD patients.”
Similar to a study presented at ASN Kidney Week that showed IV-administered difelikefalin reduced itch intensity for patients on hemodialysis, this 12-week trial was designed to test the safety and efficacy of three dose levels of oral Korsuva (0.25 mg, 0.5 mg and 1 mg, once daily) vs. placebo in 240 patients with stage 3 to 5 CKD. The daily 24-hour worst itching intensity numeric rating scale (WI-NRS) was used to gauge itch intensity throughout the study period. Itch-related quality of life was also considered and was assessed by the total skindex-10 and 5-D itch scales.
Researchers found that, after the 12-week period, patients treated with 1 mg of oral difelikefalin daily had a significant reduction in weekly mean of the daily WI-NRS scores vs. the placebo group (-4.4 vs. -3.3 for placebo). In addition, 72% of patients taking oral difelikefalin achieved a 3-point or greater improvement from baseline in the weekly mean of the daily WI-NRS score at week 12 compared with 58% of those taking placebo.
Although these results did not achieve statistical significance, researchers reported that patients who took oral difelikefalin also showed improvements in itch-related quality of life. The most common adverse effects included dizziness, fall, diarrhea and constipation.
“CKD-associated pruritus remains a significant unmet need for approximately one-third of diagnosed CKD patients in the U.S.,” Derek Chalmers, PhD, DSc, president and CEO of Cara Therapeutics, said. “We are pleased that this phase 2 study has successfully identified an appropriate tablet strength of oral Korsuva to carry forward into a pivotal phase 3 registration program which we expect to initiate next year.”
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