FDA approves first injection treatment to help alleviate severe itching while undergoing dialysis

There is good news for people on dialysis who experience debilitating itching. The U.S. Food and Drug Administration (FDA) recently approved Cara Therapeutics' injection IV KORSUVA (difelikefalin) — the first-of-its-kind treatment for people who experience moderate to severe itching, known as pruritis, while undergoing dialysis.

Chronic itching is one of the most common and challenging side effects of dialysis. People often describe pruritis as an itch that is under the skin and cannot be relieved. This can significantly impair people's quality of life, with people experiencing poor sleep and increased depression as a result. This is the first and only FDA-approved treatment for a condition that affects 40-50% of people on dialysis.

IV KORSUVA is designed to be administered three times a week after each dialysis treatment. The medicine helps to reduce the activity of the sensory nerve that causes itching from the skin to the spinal cord and to the brain. Patient engagement throughout the clinical trial process helped successfully bring this new medication to market.

In two phase three studies of 1,300 dialysis patients with moderate-to-severe itching, 40% and 37% of IV KORSUVA recipients indicated a significant improvement on their most severe itch, compared to 21% and 26% for those who received the placebo.

Patient engagement is vital for clinical trial success and has created positive impacts on various developments and regulatory processes, including improved health outcomes and enhanced quality of life. AKF is deeply dedicated to helping people with kidney disease learn more about clinical trials and engage in them. Clinical trials can lead to new therapies for people with kidney disease.

To learn more about other clinical trials for people with kidney disease, please visit our clinical trials resource page.