Drs. Neal Bhatia and Ted Rosen
Part 4 of an 8-part series on the large number of new topical and systemic medications that have become available or moved closer to approval in the last 12 months.
BBI-4000 (sofpironium bromide) is a new molecule that has been developed for the treatment of primary axillary hyperhidrosis (excessive underarm sweating). It is a “soft anticholinergic” that exerts it topical action and is rapidly metabolized into a considerably less active metabolite that reduces systemic side effects. Results from a phase IIb study of BBI-4000 were presented at the 2016 American Academy of Dermatology Annual Meeting. This 28-day trial evaluated the safety, tolerability and efficacy of three concentrations of BBI-4000 (5, 10, and 15%) versus placebo gel in 189 people with primary axillary hyperhidrosis. Study results indicated that BBI-4000 met its primary endpoint by successfully achieving a 2-grade improvement in the Hyperhidrosis Disease Severity Score (HDSS), in a dose-related fashion. At the maximum dose (15%), 38.3% of participants improved more than 2 points on HDSS at Day 29 vs 12.2% with vehicle. BBI-4000 also achieved a significant 1- and 2-grade improvement in a newly developed patient-reported outcome measure, the Hyperhidrosis Disease Severity Measure Axillary (HDSM-Ax).
Using this measure, 44.7% achieved a >2-point improvement at Day 29 in the 15% treatment group vs 19.5% for vehicle. Application site reactions were uncommon, were predominantly mild-to-moderate in severity, and resolved spontaneously. Treatment-related anticholinergic side effects were predominantly mild and transient and occurred in 11.2% of subjects randomized to BBI-4000.