Avadel Pharmaceuticals announces published Phase 3 Noctiva data

Avadel Pharmaceuticals announced that the Journal of Urology, official journal of the American Urological Association, recently published results from pivotal Phase 3 clinical trial data on Noctiva nasal spray, the lowest effective dose of desmopressin. These data showed that treatment with Noctiva resulted in significant reductions in nocturic episodes in patients with nocturia. Additionally, Noctiva showed improvements in patients’ quality of life and had a well-tolerated safety profile. These results demonstrate that Noctiva is an effective treatment for adults with nocturia due to nocturnal polyuria. In two double-blind, placebo controlled, Phase 3 trials, DB3 and DB4, 1,333 patients with a mean of 2.16 or more nocturic voids per night were randomized to Noctiva 1.66 or 0.83 mcg, or placebo, for a 12-week treatment period. Existing etiologies of nocturia included nocturnal polyuria, benign prostatic hyperplasia and overactive bladder. Co-primary end points were the mean reduction in nocturic episodes per night from baseline and the percent of patients with a 50% or greater reduction in mean nocturic episodes per night. Secondary end points were the validated INTU questionnaire, time to first nocturic void, the percent of nights with one or fewer nocturic voids and the reduction in volume of urine produced at night. The results showed that reduction in mean nocturic episodes per night from baseline were significantly greater with Noctiva compared to placebo in both DB3 and DB4. The percentage of patients who achieved a 50% reduction in mean nocturic episodes per night was significantly higher with the Noctiva 1.66 mcg dose compared with placebo in the DB3 and DB4 studies, as well as the pooled analysis of both studies. A significant difference was also observed with the 0.83 mcg dose compared with placebo in the pooled analysis. Both doses of Noctiva had an acceptable safety profile and were well tolerated. The most common adverse events of nasal discomfort and nasopharyngitis were mild to moderate in intensity and occurred with similar incidence in the placebo group. Incidence of hyponatremia, defined as serum sodium regardless of symptoms or less than 130 mmol/L with symptoms, was low and occurred in five patients (1.1 percent) at the higher dose and in one patient who received placebo. No patient receiving the 0.83 mcg dose developed hyponatremia. In secondary endpoints, patients receiving the 1.66 mcg dose had a statistically significant improvement in the overall impact score reported on the INTU indicating better quality of life and a clinically meaningful benefit. These results mark the first time a decrease in nocturic episodes was correlated with improvement in patients’ quality of life in terms of how they feel and function. Compared with placebo in DB3 and DB4 studies and in the pooled analysis, both strengths of Noctiva significantly increased the time from bedtime to the first nocturic void. There was also a significant increase in the percent of nights with one or fewer nocturic episodes after treatment with Noctiva 1.66 mcg dose compared with placebo; in the pooled analysis both 0.83 mcg and 1.66 mcg doses showed significant improvement compared to placebo.
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