TAVT-119 is an amlodipine besylate gel and is in development for the treatment of chronic anal fissures.
TAVT-119 is designed to reduce anal pain and bleeding, while also having an acceptable tolerability profile and avoiding some of the limitations associated with compounded agents.
The current standard of care in the U.S. is RECTIV® (nitroglycerin) Ointment 0.4%, labelled for intra-anal application and associated with a high incidence of headache.1 Alternative treatment options for patients can include other calcium channel blockers requiring preparation by a compounding pharmacy. Compounded drugs can have several drawbacks for patients including variability in final product quality resulting from the variability between individual pharmacies, and challenges with lack of reimbursement.2
Amlodipine is a long acting calcium channel blocker that can relax smooth muscles. Oral amlodipine is currently marketed in the U.S. as NORVASC® (amlodipine besylate). Tablets for oral administration for the treatment of hypertension and coronary artery disease.
TAVT-119 is a gel containing amlodipine besylate, that will be applied topically (i.e., perianally) and is expected to exert its therapeutic effect at the site of administration without significant systemic exposure, thus reducing the systemic side effects observed with the currently approved oral formulation. TAVT-119 is currently in Phase 2 clinical development evaluating the safety and efficacy as a treatment for anal fissures.
1 Hyman NH, Cataldo PA. Nitroglycerin ointment for anal fissures: effective treatment or just a headache?. Dis Colon Rectum. 1999;42(3):383-385.
2 Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72(16):2043-2050.