Safety of AG200-15, an Investigational Transdermal Patch, in Three Phase 3 Studies [1J

Abstract

INTRODUCTION: AG200-15 (Twirla®) is an investigational transdermal contraceptive delivery system (TCDS), which delivers daily exposure of approximately 120 µg of levonorgestrel and 30Î1/4 g of ethinyl estradiol. We report the safety from three Phase 3 studies - the SECURE (ATI-CL23) study, ATI-CL12, and ATI-CL-13. METHODS: SECURE was a single-arm, 13-cycle, open-label study conducted in 2014-2016. ATI-CL12 (13-cycles) and ATI-CL13 (6-cycles) were conducted in 2010-2011 and were open-label, randomized, active-controlled (an approved oral contraceptive (OC)) safety and efficacy studies. Subjects reported all treatment emergent adverse events (TEAEs) and serious adverse events (SAEs). TEAEs were defined as adverse events with an onset date on or after the first patch application through Day 28 of the subject's final treatment cycle. The results reported represent combined safety data. RESULTS: For AG200-15 in all studies combined, 54% of 3,481 subjects had at least one TEAE, 26% had at least one study drug-related TEAE, 5% had TEAEs of severe intensity, and 11% had TEAEs resulting in study drug discontinuation. Fewer than 2 percent of subjects (n=56) had SAEs, and 0.5% (n=18) had study drug-related SAEs. The SAEs occurring in >2 subjects were cholelithiasis (n=4), deep vein thrombosis (3), pulmonary embolism (3), and depression (3). No deaths were reported. The most common TEAEs (≥-2%) included nasopharyngitis (5.7%), upper respiratory tract infection (4.5%), nausea (4.3%), headache (3.6%), and urinary tract infections (3.5%). CONCLUSION: The percentages of TEAEs and SAEs were generally similar across the Phase 3 studies. The adverse event profile of AG200-15 appears to be similar to approved OCs.