3M'S DURAPREP SURGICAL SOLUTION WINS FDA APPROVAL

3M announced that the FDA has approved its new drug application (NDA) for 3M DuraPrep surgical solution (iodine povacrylex [0.7 percent available iodine] and isopropyl alcohol, 74 percent w/w) patient preoperative skin preparation. DuraPrep surgical solution has been available and used in more than 20 million preoperative patient skin preparation procedures since 1988.

In 1994, the FDA published the Tentative Final Monograph for Healthcare Antiseptic Drug Products by which it regulates healthcare antiseptic solutions. In this monograph, the FDA limited the allowable form of iodophor used in patient preoperative skin preparations to povidone iodine. Because DuraPrep surgical solution uses a proprietary, film-forming iodine acrylate copolymer that differentiates it from treatments based on traditional povidone iodine, this monograph, when finalized, is not expected to cover DuraPrep surgical solution. After discussions with the FDA about the unique iodine acrylate copolymer in DuraPrep surgical solution, 3M decided to file an NDA to seek formal approval for the compound.

As part of the NDA, 3M submitted data from six efficacy studies and two safety studies. Three studies involving healthy volunteers tested DuraPrep surgical solution's efficacy on the abdomen and groin. All three studies showed DuraPrep surgical solution was either generally equivalent or superior to Hibiclens cleanser, a chlorhexidine gluconate aqueous-based antimicrobial solution.