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

Open to people ages 18-75

• Diagnosed with IC/BPS by a urologist or other clinician specializing in IC/BPS
• Chronic bladder pain associated with filling the bladder over the past 6 months
• Compliant with eDiary completion and meets weekly average daily score for bladder pain at its worst during the pretreatment period
• Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2 voids/night, daytime frequency >8×day, urgency
• Body mass index (BMI) ≤40 kg/m2
• Willing to use a rectally administered product once daily for 12 weeks

• Male subject has history of bacterial prostatitis or benign prostatic hyperplasia with active symptoms that are difficult to distinguish from IC/BPS
• Has a condition that can be a contraindication to using a rectal foam
• Has cancer under active treatment or a history of uterine, cervical, pelvic, colorectal, ovarian, or vaginal cancer
• Has a history of benign or malignant bladder tumors
• Has an active urinary tract infection or had ≥2 UTIs within the past 90 days
• Has an uncontrolled major psychiatric condition or has made a suicide attempt during the past 2 years
• Has a malabsorption syndrome
• Had surgery in the pelvic or abdominal region within the past 90 days or is planning pelvic or abdominal region surgical procedures before the end of the study
• Has received a cystoscopy with or without hydrodistension for diagnostic purposes (ie, not for pain relief) within the past 30 days or a cystoscopy with therapeutic hydrodistension (ie, for pain relief) within the past 90 days or is planning a cystoscopy for any reason before the end of the study
• Has history of pelvic irradiation or radiation cystitis, or drug-induced cystitis.
• Has a recent history of drug or alcohol abuse