Desmopressin: PRN Treatment in OAB Prospective, randomised, multi-centre, multinational, double-blind, placebo controlled observational study Prospective, randomised, multi-centre, multinational, double-blind, placebo controlled observational study 60 women with severe daytime urinary incontinence 60 women with severe daytime urinary incontinence PRN desmopressin 40µg spray vs placebo PRN desmopressin 40µg spray vs placebo Primary Endpoint: Primary Endpoint: 4hr dry period following dosing Secondary Endpoints: Secondary Endpoints: time to first void / incontinence episode Voided volumesDry periods Patients taking desmopressin; Patients taking desmopressin; Higher frequency of dry daysLower voided volume Longer time to first void/incontinence episode Robinson et al, 2004

PRN Desmopressin: Efficacy in First 4 Hours DesmopressinPlaceboDifference Incidence of periods without leak (%) N Mean (SD)61.7 (35.4)47.9 (40.2)14.4 (28.1) Median Min - Max0.0 – – 85.7 Total volume voided (ml) N5958 Mean (SD)237 (121)317 (194)-82 (180) Median Min - Max74.3 – – Robinson et al, 2004

Desmopressin: PRN Treatment in OAB 37% of patients had no leakage on virtually all 37% of patients had no leakage on virtually all treatment days for 4 hours after administration 4-8 hours: 67.8% incidence of dry periods on desmopressin Vs 62.7% on placebo 4-8 hours: 67.8% incidence of dry periods on desmopressin Vs 62.7% on placebo 8-24 hours: incidence of dry periods was similar 8-24 hours: incidence of dry periods was similar No serious adverse effects; 11% failed to complete No serious adverse effects; 11% failed to complete Desmopressin is safe and effective, allowing women to choose when they need treatment Desmopressin is safe and effective, allowing women to choose when they need treatment Self-motivation allows choice; thus improving compliance Self-motivation allows choice; thus improving compliance Robinson et al, 2004

Desmopressin: PRN Treatment in OAB 2 week, multi-national, multi-centre, proof of concept, phase IIB, double blind, placebo controlled, prospective randomised cross over study 2 week, multi-national, multi-centre, proof of concept, phase IIB, double blind, placebo controlled, prospective randomised cross over study Men and women with OAB Men and women with OAB Inclusion: Inclusion: ≥4 voids in the first 8 hrs after rising ≥4 voids in the first 8 hrs after rising Oral Desmopressin 0.2mg Vs Placebo Oral Desmopressin 0.2mg Vs Placebo Primary endpoint; Primary endpoint; Effectiveness of desmopressin in increasing the time to first OAB symptom episodes during 8 hrs post dose Hashim et al, 2009

Desmopressin: PRN Treatment in OAB Time to 1 st void 8 min later on desmopressin (p=0.27) Time to 1 st void 8 min later on desmopressin (p=0.27) Desmopressin; Desmopressin; One less void per 8hrs (3.2 vs 4.2)(p<0.001) Increase in time to first urgency episode(p<0.003) Decrease in urgency episodes(p<0.003) Subjective improvement in frequency and urgency Subjective improvement in frequency and urgency Improvement in QoL using ICIQ-OAB Improvement in QoL using ICIQ-OAB Adverse events reported as mild, no hyponatremia Adverse events reported as mild, no hyponatremia Novel, feasible and safe short term treatment for OAB Novel, feasible and safe short term treatment for OAB Hashim et al, 2009