Leveraging the HyantX delivery system, BPX-04 (minocycline), 1% is a novel topical gel formulation of fully solubilized minocycline for the treatment of moderate-to-severe papulopustular rosacea. The product has demonstrated safety and efficacy in a randomized, double‑blind, vehicle‑controlled Phase 2b clinical trial enrolling 206 subjects with moderate-to-severe papulopustular rosacea.
The below table details the primary and secondary efficacy results from the trial whereby BPX-04 demonstrated a statistically significant improvement from baseline. In addition to meeting the primary and secondary endpoints of the trial, BPX-04 demonstrated a statistically significant reduction in the number of facial inflammatory lesions at all time points (weeks 4, 8 and 12).
BPX-04 appeared to be generally well-tolerated. The most commonly reported adverse events across both treatment groups were upper respiratory tract infection (5.3%), gastroenteritis (2.4%) and headache (2.4%) with the majority of these adverse events determined to be not treatment-related. There were no serious treatment-related adverse events.
ROSACEA – The National Rosacea Society describes rosacea as a common, but poorly understood disorder of the facial skin that affects an estimated 16 million Americans, many of whom do not even know they have the condition. Rosacea is characterized by facial redness, pimples, bumpy breakouts, and thickening of the skin. The condition can also affect the eyes by causing dry eyes and blurred vision.