The Safety and Tolerability of Budesonide Foam in Subjects With Active Ulcerative Proctitis or Proctosigmoiditis

This is a Phase 3, multicenter, open label study in subjects who have participated
previously in a Salix-sponsored budesonide rectal foam study for the treatment of ulcerative
proctitis or proctosigmoiditis. Approximately 300 subjects will be enrolled into the study
and receive budesonide foam cyclically for 6 weeks (BID for 2 weeks and QD for 4 weeks) each
time they have an ulcerative proctitis or proctosigmoiditis flare. The study will continue
until regulatory approval of budesonide foam occurs, or the sponsor decides to terminate the
study.

Inclusion Criteria:

- Male or non-pregnant, non breast-feeding females ≥ 18 years old.

- Subject has previously been diagnosed with active mild to moderate UP/UPS and is
currently experiencing symptoms of active UP/UPS disease after having completed
participation in Salix's BUCF3001 or BUCF3002 study.

- Willingness to undergo sigmoidoscopy.

Exclusion Criteria:

- Active systemic, ocular or cutaneous infection (e.g., parasitic, fungal, amoebic,
viral or bacterial disease).

- History of sclerosing cholangitis, cirrhosis, or hepatic impairment, including
chronic hepatitis of any etiology.

- Subject has taken systemic, inhaled, oral, topical or rectal corticosteroids (other
than budesonide rectal foam) within 7 days of starting a treatment cycle.

- Subject has taken ketoconazole and other potent CYP3A4 inhibitors within 7 days of
starting a treatment cycle.

- Subjects who take diuretics with cardiac glycosides.

- Unstable significant cardiovascular, hepatic, renal, endocrine, neurologic or
pulmonary disease.