FDA Wants Additional Trial of LV-101 Nasal Spray to Confirm Efficacy
The U.S. Food and Drug Administration (FDA) has told Levo Therapeutics that an additional clinical trial will be necessary to confirm the efficacy of LV-101 (intranasal carbetocin), a nasal spray aimed at reducing insatiable hunger, called hyperphagia, in Prader-Willi syndrome (PWS) patients. Levo Therapeutics had submitted a new drug…