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

Inclusion Criteria: * 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 Exclusion Criteria: * 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 cystoscop…