PD21-04 EXTENDED CONTINUOUS INTRAVESICAL DELIVERY OF TROSPIUM CHLORIDE SIGNIFICANTLY IMPROVES OAB SYMPTOMS OVER 12 WEEKS

Abstract

INTRODUCTION AND OBJECTIVE: Overactive Bladder (OAB) is a serious and prevalent condition, with symptoms affecting roughly1 in 6 adults[1]. A substantial need exists for therapies with better efficacy, reduced side effects, and improved patient convenience and compliance over existing therapies. TAR-302 is a novel drug-device combination product that continuously delivers trospium chloride into the bladder for prolonged periods. This abstract presents the results of a clinical study in 31 subjects administered a single dose for 84 days. METHODS: This open label Phase 1 study evaluated the safety, tolerability, and preliminary efficacy of TAR-302 in patients with wet OAB failing oral therapy. The protocol was reviewed and received ethical approval by IRBs for each participating study site. Subjects received one intravesical dose of TAR-302 for 84 days. TAR-302 was placed via insertion catheter and removed via cystoscope. Pharmacokinetic (PK) analyses were conducted in blood and urine. Response to TAR-302 was assessed using 3-day incontinence diaries and the OAB-q Short Form (OAB-q SF). RESULTS: Median patient age was 60; 27 of 31 (87%) subjects were female. 29 of 31 subjects successfully completed the study. TAR-302 was well tolerated: treatment-emergent adverse events (AEs) were all mild to moderate. There were 3 cases of UTI and 1 case of symptomatic bacteriuria. Mean daily urge incontinence (UI) was reduced by 48.5% at Day 84 vs. baseline (5.33/Day to 2.75/Day, p<0.001; this benefit appeared durable 4 weeks after TAR-302 removal (44.6% reduction, 2.95/Day at Day 112; p<0.001). Subjects experienced clinically and statistically significant improvements in both domains of the OAB-q SF. Detailed efficacy data are presented in Figures 1 & 2. CONCLUSIONS: TAR-302 demonstrated encouraging safety, tolerability, and preliminary efficacy in the management of symptoms for patients with OAB. This potential therapy warrants further study. Source of Funding: TARIS Biomedical LLC