No Substantial Evidence of LV-101 Nasal Spray’s Efficacy, FDA Committee Votes

No Substantial Evidence of LV-101 Nasal Spray’s Efficacy, FDA Committee Votes

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No Substantial Evidence of LV-101 Nasal Spray’s Efficacy, FDA Committee Votes

There is no substantial evidence supporting the efficacy of LV-101 (intranasal carbetocin), a nasal spray designed to reduce the insatiable hunger, called hyperphagia, that’s a hallmark of Prader-Willi syndrome (PWS), according to a 12-1 vote by a U.S. Food and Drug Administration (FDA) advisory committee. The overwhelmingly negative vote followed a six-hour virtual public meeting, held Nov. 4, in which the FDA committee reviewed clinical trial data and then heard the opinions and experiences — this, positive…

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