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 bladderpain at its worst during the pretreatment period

• Has at least 1 of the following urinary symptoms over the past 6 months: nocturia ≥2voids/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 hyperplasiawith 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 duringthe past 2 years

• Has a malabsorption syndrome

• Had surgery in the pelvic or abdominal region within the past 90 days or is planningpelvic 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 therapeutichydrodistension (ie, for pain relief) within the past 90 days or is planning acystoscopy 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