Phase 2 Study of IW-3300 for the Treatment of Bladder Pain in Subjects With Interstitial Cystitis/Bladder Pain Syndrome

The aim of this study is to assess whether IW-3300 is safe and works for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS). The main question the study aims to answer is whether IW-3300 helps bladder pain and other symptoms (for example, bladder burning, pressure and discomfort). Subjects will be assigned to receive either the study drug or placebo by chance.

Inclusion Criteria:Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPSChronic bladder pain associated with filling the bladder over the past 6 monthsCompliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment periodHas at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgencyBody mass index (BMI) ≤40 kg/m2Willing to use a rectally administered product once daily for 12 weeksExclusion Criteria:Male subject has history of bacterial prostatitis or benign prostatic hyperplasiaHas a condition that can be a contraindication to using a rectal foamHas cancer under active treatment or a history of uterine, cervical, pelvic, rectal, ovarian, or vaginal cancerHas a history of benign or malignant bladder tumorsHas an active urinary tract infection or had ≥2 UTIs within the past 90 daysHas an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 yearsHas a malabsorption syndromeHad surgery in the pelvic or abdominal region within the past 90 daysHas received a cystoscopy (with or without hydrodistension for reason other than pain relief) for diagnostic purposes within the past 30 days or a cystoscopy involving therapeutic hydrodistension (for pain relief) within the past 90 daysHas history of pelvic irradiation or radiation cystitisHas a recent history of drug or alcohol abuse