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Levo’s Carbetocin Faces Advisory Committee Hurdle Given FDA ‘Uncertainty’ About Its Effectiveness

 
• By Brenda Sandburg

US FDA points to inconsistency in Phase II and Phase III study results, lack of additional substantiating studies and lack of robust statistical findings. Advisory committee is to vote on whether there is ‘substantial evidence’ that the nasal spray is effective in treatment of hyperphagia associated with Prader-Willi syndrome.

Hurdle
Levo faces hurdle in getting advisory committee vote for its Prader-Willi syndrome treatment • Source: Alamy

The odds seem against Levo Therapeutics, Inc.’s carbetocin nasal spray getting an advisory committee endorsement for treatment of hyperphagia (unrelenting hunger) associated with Prader Willi syndrome given the US FDA’s negative assessment of the company’s data.

Levo’s new drug application includes two studies. The first, Study 114, is a Phase II randomized, double-blind, placebo-controlled proof-of-concept study of 9.6 mg intranasal carbetocin three times a day versus...

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