Pharmacokinetic,Safety and Exploratory Efficacy of RECTIV® in Adolescents With Chronic Anal Fissure

Key Inclusion Criteria:

• Male or female ≥12 and <17 years of age

• At least 1 anal fissure for a minimum of 3 weeks in duration

• Anal fissure pain experienced over the last 24 hours at Screening and beforeenrollment

• Patient (and parent or caregiver as appropriate) has provided written informed consent

Key Exclusion Criteria:

• Current diagnosis of hemorrhoids

• Hypersensitivity, allergy, or contraindication to nitroglycerin

• History of hypertension and/or cardiovascular disease

• History or current diagnosis of inflammatory bowel disease

• History or current diagnosis of fistula(e)-in-ano or an anal abscess

• Fibrotic anal stenosis

• Previous anal surgery

• Diagnosis of cancer

• History of migraine or chronic headaches requiring treatment with analgesics

• Pregnant or lactating female patients

• Weight <36 kg