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# FDA Rejects Levo Therapeutics’ Carbetocin NDA
- URL: https://www.fdaweb.com/fda-rejects-levo-therapeutics-carbetocin-nda/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150948

FDA has issued Levo Therapeutics a complete response letter on its NDA for LV-101 (intranasal carbetocin) as a treatment for hyperphagia, anxiousness, and distress associated with Prader-Willi syndrome (PWS). CDER’s Division of Psychiatry concluded that, while LV-101 appears to be generally safe and well tolerated, the efficacy data available for the proposed 3.2 mg dose of LV-101 were insufficient for approval, according to the company. The agency recommended that an additional clinical study be conducted to confirm the results of the 3.2 mg dose. Levo says it is “currently in discussions with FDA regarding the design of this new study and continues to provide carbetocin to existing study patients.”

PWS is a rare, complex, neurodevelopmental disorder that is characterized by a false sense of starvation and associated hyperphagia (unrelenting hunger), to which a deficiency in oxytocin is believed to be contributory, according to the company.

The NDA rejection likely came as no surprise after FDA’s Psychopharmacologic Drugs Advisory Committee 11/5 voted 12 to 1 that the submission did not show significant evidence of effectiveness. “The primary endpoints were definitively negative; secondary endpoints were encouraging but questionable, and not even statistically significant when appropriately analyzed,” one panel member said.

Carbetocin is an analog of the naturally-occurring neuroendocrine hormone oxytocin. It was “designed to have an improved receptor binding profile compared to oxytocin, with greater affinity for the oxytocin receptor and lower affinity for related vasopressin receptors,” the company says. It is approved in over 90 countries outside the U.S. for preventing uterine atony and excessive bleeding during cesarean section delivery.