Abstract: PD26-03
Sources of Funding: Allergan plc, Serenity Pharma LLC.

Introduction

Nocturia (waking at night to void) is a bothersome condition associated with many underlying etiologies. Two randomized, placebo-controlled phase 3 trials demonstrated the efficacy/safety of SER120, a very low-dose desmopressin nasal spray formulation in patients (pts) with nocturia. A pooled analysis of the two trials compared the efficacy of SER120 in nocturia pts with contributing etiologies of nocturnal polyuria (NP), overactive bladder (OAB), and benign prostatic hyperplasia (BPH).

Methods

Two phase 3 trials enrolled pts ≥50 y of age with ≥2 nocturic episodes/night (irrespective of etiology) for at least 6 months. Pts (N=1333) were randomized 1:1:1 to SER120 0.75 mcg, 1.5 mcg or placebo for a 12-week treatment period after a 2-week double-blind, placebo lead-in phase. Data from the two phase 3 trials were pooled for analysis by the contributing etiologies of NP (n=1045); OAB (n=366); and BPH (n=518). The co-primary efficacy endpoints were mean change from baseline in nocturic episodes/night and percentages of pts with ≥50% reduction in mean nocturic episodes/night.

Results

Overall, the baseline mean nocturic episodes/night were 3.3, 3.4 and 3.3 in the SER120 0.75 mcg, 1.5 mcg, and placebo groups, respectively. SER120 at both doses resulted in significantly greater reductions in nocturic episodes/night vs placebo, regardless of etiology. The mean reductions in nocturic episodes with SER120 0.75 and 1.5 mcg vs placebo were -1.4 and -1.5 vs -1.2 in pts with NP (P<.0001 for both doses); -1.4 and -1.5 vs -1.0 in OAB pts (P=.0015; P<.0001 ); and -1.3 and -1.4 vs -1.1 in BPH pts (P=.0236; P=.0063). A significantly higher percentage of pts achieved ≥50% reduction in nocturic episodes/night in groups with NP (37.3% and 48.0% vs 27.5%; P=.0055; P<.0001), OAB (40.2% and 48.9% vs 28.3%; P=.0452; P=.0005) and BPH (31.4% and 38.3% vs 22.5%; P=.0012 for 1.5 mcg).

Conclusions

SER120 at doses of 0.75 mcg and 1.5 mcg is effective for the treatment of nocturia in pts with any etiology or a combination of etiologies, including those diagnosed with NP, OAB and BPH. Pts experienced significantly greater reductions in mean nocturic episodes with SER120 at both doses, regardless of etiology. Significantly higher responder rates were achieved with SER120 at both doses in pts with NP and OAB, and with SER120 1.5 mcg dose in pts with BPH. SER120 had an adequate safety profile and was well tolerated.

Funding

Allergan plc, Serenity Pharma LLC.