The Safety and Efficacy of AF-219 in Female Subjects With Interstitial Cystitis /Bladder Pain Syndrome

This study is a double-blind, placebo-controlled, randomized trial designed to assess the
efficacy and safety of a single dose level of AF-219 in female subjects with moderate to
severe IC/BPS. The study will consist of 4 phases: Screening, Baseline, Treatment, and
Follow-up.

Inclusion Criteria:

- Women

- Women of child bearing potential must not be pregnant during the study and must use
two forms of birth control

- Clinical evidence of IC/BPS

- Have provided written informed consent

Exclusion Criteria:

- History of diseases that can be confused for IC/BPS

- Unable to void spontaneously

- Immunosuppressant, intravesicular, nerve stimulator or opioid treatment during the
study and for certain periods prior to start of the study.

- Changes to doses of Elmiron®, antidepressant, alpha-adrenergic antagonist, H1
antagonist, or anti-muscarinic treatment within a certain period prior to the start
of the study.