A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)

Inclusion Criteria:

- Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of
overactive bladder including: frequency, urgency, urgency urinary incontinence, and
mixed 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., uterine prolapse,
malignancy, prior surgery, or treatment with botulinum toxin.

- 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 ≥ 100 mmHg, 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