Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

Inclusion Criteria:

- Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of
overactive bladder including: frequency, urgency, and urgency urinary incontinence.
Subjects must provide written informed consent and either be of non-childbearing
potential or of childbearing potential meeting specific criteria (e.g., negative
pregnancy test, sexual inactivity, acceptable methods of birth control, and use of
hormonal contraceptives).

Exclusion Criteria:

- Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine
prolapse, urogenital malignancy within the past 2 years, surgery for stress
incontinence or pelvic prolapse repair within the past 6 months, or bladder injections
with botulinum toxin at any time.

- Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus

- Cardiac conditions: prior cardiovascular events or procedures within 6 months of
screening; congestive heart failure; abnormal ECG findings, including ECG QT
correction interval (QTc) > 470 msec at the Screening Visit; systolic blood pressure ≥
180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate > 100 beats per minute.

- Abnormal tests of liver function

- History of prior infection due to HIV or hepatitis B or hepatitis C virus

- Allergy or hypersensitivity to solabegron or mirabegron

- Women of childbearing potential: breastfeeding, pregnant, or actively trying to become
pregnant

- Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the
Screening Visit or in any clinical trial of an investigational drug that may affect
urinary function within 3 months prior to Screening Visit.

- Inability to read, understand, or complete study-related materials.