Levo Therapeutics announced that the FDA has issued a complete response letter to the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger and anxiety associated with Prader-Willi syndrome (PWS). The FDA accepted the application for priority review in July 2021. According to Levo, the FDA has requested an additional clinical study to provide more efficacy data for the 3.2 mg dose of LV-101, and the company is discussing the study design with the agency.
Levo licensed the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and initiated a Phase 3 trial of the nasal spray in December 2018. In August 2020, the company announced that the trial, which had stopped enrolling PWS patients due to the COVID-19 pandemic, had missed its primary endpoint but had demonstrated improvement in several secondary endpoints.
Levo Therapeutics CEO Sara Cotter commented, “We are disappointed by the outcome of FDA’s review of our application and the continued lack of treatments for the most significant symptoms of the syndrome. We are hopeful that our discussions with FDA regarding the next study will be productive and that we can initiate enrollment of a confirmatory study later this year.”
Foundation for Prader-Willi Research Director of Research Programs Theresa Strong said, “We remain steadfast in our support of carbetocin and all potential treatments for our community. We hope that, going forward, FDA will recognize the tremendous unmet need and exercise the flexibility it has when considering new products for rare, serious diseases such as PWS.”
Read the Levo Therapeutics press release.
