SOLUPREP SIDE EFFECTS

SIDE EFFECTS

A total of 1544 subjects received at least one treatment in the studies supporting approval: pivotal studies (one of the studies, a study of 169 subjects, was discontinued early due to technical and quality issues), the persistence study, the two coverage area and dry time studies, the two drape adhesion clinical studies and the three safety challenge studies. Exclusion criteria in trials included known hypersensitivity. Thirty-one (31) AEs (2%) were reported. Adverse events reported in the development program were typically related to the skin, mild to moderate in severity and similar to typical adverse events associated with this type of product. Nine moderate adverse events occurred in studies designed to evaluate safety under exaggerated conditions. Seven discontinuations occurred secondary to adverse events in the Human Safety Studies. A few (12) adverse events required treatment. All adverse results resolved or stabilized.

Skin irritation scores of 0 to 3 for categories of erythema, edema, rash and dryness were collected for many of the clinical studies. A skin irritation rating of 3 represented significant irritation and qualified as an adverse event. There was no skin irritation rating of 3 in any clinical study. Under wet conditions in one of the studies of drape adhesion, moderate reactions of erythema were seen with all surgical preparations including this NDA product.