Avadel data shows increase in duration of FUSP with Noctiva
Avadel Pharmaceuticals presented data from two abstracts from Phase 3 clinical trials of NOCTIVA at the American Urogynecologic Society Annual Scientific Meeting, Pelvic Floor Disorder Week 2018 in Chicago, Illinois from October 9-13. These data show that patients treated with NOCTIVA Nasal Spray - the lowest effective dose of desmopressin - experienced an increase in both duration of first uninterrupted sleep period and percentage of nights with one or no nocturic voids, and NOCTIVA's safety profile was well-tolerated. These results show that NOCTIVA is an effective therapy in patients with nocturia due to nocturnal polyuria. The efficacy of NOCTIVA on FUSP and safety, as secondary endpoints, were evaluated in patients age 50 years and older with nocturia due to nocturnal polyuria in two Phase 3 randomized, double-blind pivotal studies. FUSP is defined as elapsed time from bedtime to first NOV or awakening if no void occurred. Patients were randomized into three groups and received either 1.66 mcg or 0.83 mcg of NOCTIVA, or a placebo for 12 weeks. The baseline average FUSP for all groups was 2.4 hours. In the NOCTIVA 1.66 mcg group, FUSP increased by 1.8 hours to 4.2 hours, and in the NOCTIVA 0.83 mcg group, FUSP increased by 1.6 hours to 4.0 hours, which was statistically significant compared to placebo. Incidence and severity of adverse events were similar to placebo, and the incidence of hyponatremia, defined as serum sodium less than or equal to125 mmol/L regardless of symptoms or less than130 mmol/L with symptoms, was low for both doses. No patients treated with 0.83 mcg experienced serum sodium less than or equal to125 mmol/L. These results demonstrate that NOCTIVA is an effective therapy with a well-tolerated safety profile in patients with nocturia due to nocturnal polyuria and may provide longer periods of uninterrupted sleep.