Cara Therapeutics Inc (NASDAQ:CARA) stock was flying high on Friday following good news from the U.S. Food and Drug Administration (FDA).
The good news that is sending CARA stock up today is the awarding of “Breakthrough Therapy” status to I.V. CR845. I.V. CR845 is Cara Therapeutics Inc’s treatment for moderate-to-severe uremic pruritus in chronic kidney disease patients undergoing hemodialysis.
Cara Therapeutics Inc’s I.V. CR845 is being awarded the Breakthrough Therapy status so that it can be developed more quickly. This is done for treatments that have evidence that they will work better than current methods.
Cara Therapeutics Inc’s drug has the evidence to back it. A Phase 2/3 clinical trial of I.V. CR845 saw the drug meet both its primary and secondary endpoints. This includes a 68% reduction in worse itching scores and a 100% improvement to quality of life.
“The FDA’s decision to grant Breakthrough Therapy designation is recognition of both the significant unmet medical need among CKD patients with UP and the potential of I.V. CR845 to address it,” Derek Chalmers, President and CEO of Cara Therapeutics Inc, said in a statement. “We have already initiated our Phase 3 program and look forward to working closely with the FDA to bring this potential new treatment option to hemodialysis patients as quickly as possible.”
Cara Therapeutics Inc’s next Phase 3 study will include 240 hemodialysis patients with CKD-associated pruritus that have already taken part in its previous studies. The goal will be to determine the long-term safety of the drug.
Marijuana stocks, such as CARA, have been gaining attention of late. This is due to regulations around the drug becoming more relaxed.
CARA stock was up 9% as of noon Friday and is up 134% year-to-date.
As of this writing, William White did not hold a position in any of the aforementioned securities.