FDA fast tracks intranasal oxytocin analogue for Prader-Willi syndrome

The FDA this week granted fast track designation for intranasal carbetocin, an oxytocin analogue, for the treatment of Prader-Willi syndrome, according to a press release from Levo Therapeutics.

Carbetocin was designed to have an improved receptor binding profile when compared with oxytocin, with greater affinity for the oxytocin receptor and lower affinity for related vasopressin receptors, according to Levo. The drug is approved in more than 90 countries outside the United States for the prevention of uterine atony and excessive bleeding during cesarean section delivery, with an estimated cumulative exposure of more than 10 million patients. LV-101 is an investigational intranasal form of carbetocin, intended to be administered to people with Prader-Willi syndrome three times daily before meals.

“We are thrilled to receive fast track designation from the FDA, which supports the understanding among the Prader-Willi syndrome community that this syndrome presents serious and life-threatening issues,” Sara Cotter, CEO of Levo Therapeutics, said in the release. “Levo is committed to developing impactful treatments for patients with Prader-Willi syndrome, and our phase 3 study is designed to see whether intranasal carbetocin provides one such treatment. We look forward to finishing enrollment of this important clinical study in the coming months.”

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