Phase II Study Efficacy and Safety of Two Dosing Regimens of MN-001 in Patients With Interstitial Cystitis

Inclusion Criteria: Male or female ≥ 18 years of age with a diagnosis of moderate to severe IC; Bladder pain ≥ 6 months prior to baseline; Urinary frequency of ≥ 8 ≤ 30 micturitions within 24 hours while awake; Nocturia ≥ 2x/night; Males and females of child-bearing potential (not surgically sterile or post-menopausal) must be abstinent or agree to use an study-accepted contraceptive regimens throughout the study: Female patients of child bearing age must have a negative urine pregnancy test at screening; Must provide a signed informed consent. Exclusion Criteria: Male or females < 18 years of age; Initiation of new IC medication ≤ 30 days prior to baseline; Treatment with Elmiron ≤ 120 days prior to baseline; Treatment with bladder hydro-distention ≤ 6 months prior to baseline; Treatment with intravesical therapy ≤ 60 days prior to baseline; History of previous procedure(s) (e.g., augmentation cytoplasty, cystectomy or cystolysis) that has affected bladder function; Active genital herpes or vaginitis ≤ 90 days prior to baseline; Urinary tract or prostatic infection ≤ 90 days prior to baseline; History of urethral diverticulum; History of bladder or ureteral calculi; History of cyclophosphamide or chemical cystitis, urinary tuberculosis or radiation cystitis; History of bladder tumors; History of uterine, cervical, vaginal, prostatic or urethral cancer ≤ 5 years prior to baseline; Patient is currently pregnant, lactating or likely to become pregnant during the study; Participated in another clinical study with an investigational drug or device ≤ 30 days prior to baseline.