Cara Gets US Approval Of I.V. Korsuva, But Prospects Murky For Oral Version

The kappa opioid receptor agonist is not listed as a scheduled substance and labeling meets expectations. Cara and partner Vifor plan to launch the product in early 2022.

Dialysis center Korsuva approval
Cara and Vifor hope to bring Korsuva to market in early 2022 • Source: Alamy

Cara Therapeutics, Inc. and Vifor Pharma Group ’s Korsuva (difelikefalin) reached the end of the long path to approval on 23 August, as the intravenous kappa opioid receptor agonist was cleared by the US Food and Drug Administration to treat pruritus in chronic kidney disease patients on dialysis. Cara’s prospects for an oral version of the drug remain unclear, however, given mixed data reported earlier this year in atopic dermatitis.

For more than a decade, Connecticut-based Cara has built its whole business strategy around difelikefalin, with a particular emphasis on...

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