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Clincal Review(S) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 208288Orig1s000 CLINICAL REVIEW(S) Division Director Review NDA 208288 Chlorhexidine gluconate/isopropyl alcohol Summary Review for Regulatory Action Date September 1, 2017 Theresa M. Michele, MD From Director, Division of Nonprescription Drug Products Subject Division Director Summary Review NDA/BLA # 208288 Applicant Name 3M Health Care Business Date of Submission March 3, 2017 PDUFA Goal Date September 3, 2017 SoluPrep™ Film-Forming Sterile Solution / 2%w/v Proprietary Name / chlorhexidine gluconate and 70% v/v isopropyl Established (USAN) Name alcohol Dosage Forms / Route of Surgical solution Administration / Strength Patient Preoperative Skin Preparation (adults and pediatric patients ≥ 2 months of age) Proposed Indication(s) • For preparation of the skin prior to surgery • Helps reduce bacteria that potentially can cause skin infection Recommended Regulatory Complete response Action Material Reviewed/Consulted OND Action Package, including: Names of discipline reviewers Medical Officer Review--DNDP Teresa Podruchny/Francis Becker Statistical Review Joo-Yeon Lee/Rima Izem Pharmacology Toxicology Review Charlie Thompson/Jane Sohn CMC Review/OBP Review Elise Luong/Maria Cruz-Fisher/Erika Pfeiler/ Swapan De Clinical Microbiology Review Michelle Jackson Clinical Pharmacology Review Sojeong Yi/Dennis Bashaw CDTL Review Francis Becker OSE/DMEPA Grace Jones/Chi-Ming Tu RPM DNDP Lara Akinsanya CDTL=Cross-Discipline Team Leader DMEPA=Division of Medication Error Prevention and Analysis DNDP=Division of Nonprescription Drug Products IDS=Interdisciplinary Scientist OND=Office of New Drugs RPM=Regulatory Project Manager OBP=Office of Biotechnology Products 1 Reference ID: 4147866 Division Director Review NDA 208288 Chlorhexidine gluconate/isopropyl alcohol 1 INTRODUCTION This is the second cycle for this 505(b)(2) new drug application seeking approval for direct to OTC combination product of chlorhexidine gluconate 2% and isopropyl alcohol 70% solution (CHG/IPA; proposed trade name SoluPrep™) as a patient preoperative skin preparation for preparation of the skin prior to surgery and to help reduce bacteria that potentially can cause skin infection. This indication is well-established in the OTC space for both NDA and monograph products, and the language is consistent with other approved OTC patient preoperative skin preparation products. The product contains a film-forming acrylate copolymer which the sponsor states stays dissolved until it is applied on the skin to produce a water-insoluble film. Unlike currently approved CHG/IPA products currently approved, the 3M product is provided as a sterile solution in a sterile applicator. The NDA includes 3 different presentations of the product, a colorless solution in a 10.5 mL applicator, a green-tinted solution in a 10.5 mL applicator, and a green-tinted solution in a 26 mL applicator. In the first cycle, FDA issued a Complete Response determination on May 6, 2017, due to the following deficiencies: • Clinical: failure to demonstrate replicative efficacy in the groin region and inadequate financial disclosure • Clinical pharmacology: inadequate data to demonstrate absorption • Nonclinical: failure to provide qualification data for two impurities • Product quality: unacceptable limits for impurities, with inadequate justification for expiry dating • Microbiology: a number of deficiencies related to container closure integrity testing and validation to ensure sterility This review will focus only on issues related to the complete response. 2 REGULATORY HISTORY After the complete response, FDA held a Type A meeting with 3M on July 15, 2016. Discussion was held regarding the recommendation to conduct an additional clinical simulation study at the groin site, data necessary to resolve the clinical pharmacology deficiency, and the sponsor’s efforts to address the financial disclosure deficiency. The sponsor asserted that based on the totality of the data, the data were sufficient to demonstrate efficacy. 3M also discussed potential reasons for divergent results between the two laboratories performing the clinical simulation studies, including the lower body mass index resulting in differences in skin folds and different microbiomes between the two geographic regions (Virginia versus Montana). The Division provided significant advice on potential pathways to resolve deficiencies but did not agree with the sponsor’s assertion that further clinical simulation studies were unnecessary. On August 12, 2016, 3M requested formal dispute resolution to appeal the Division’s determination that the clinical simulation studies were insufficient for approval due to failure to provide replicative evidence of efficacy at the groin site and the recommendation to conduct a repeat study. Dr. Charles Ganley, ODEIV granted this appeal on the basis of a 2 Reference ID: 4147866 Division Director Review NDA 208288 Chlorhexidine gluconate/isopropyl alcohol number of factors, which when taken together, were deemed sufficient to support the efficacy of the proposed product. These factors included: (1) similar results were obtained to that of an approved product containing the same active ingredients, (2) in vitro testing using a time-kill approach demonstrated efficacy, (3) replicative efficacy was demonstrated in one study using two different presentations of the test product (10.5 mL and 26 mL), (4) the study that did not meet the pre-specified response rate at the groin site did meet criteria at the abdominal region, (5) there are only two laboratories in the U.S. that conduct these types of clinical simulation studies and the results are known to be variable between the labs which may reflect different populations enrolled, and (6) the results of a pilot study in Romania showed a mean log reduction in bacteria by greater than 3 log for all study arms, although the study was underpowered to meet the response criteria. Dr. Ganley goes on to note that these conclusions are not generalizable to other products, particularly those containing new active ingredients with more limited data elsewhere to support effectiveness. At the sponsor’s request, the Division held a discipline specific in review meeting on June 12, 2017, to discuss the toxicology information requests. The sponsor asserted that FDA failed to raise concerns regarding the protocol for the rabbit toxicology study conducted to qualify impurities; however, this protocol was never submitted to FDA by the sponsor. FDA provided advice to the sponsor regarding additional data needed to evaluate the submitted toxicology study and noted that additional toxicology data of the requested type would likely constitute a major amendment. Following this teleconference, the product quality and nonclinical teams issued a discipline review letter on August 11, 2017, outlining outstanding deficiencies in the application. Two subsequent teleconferences were held with the sponsor on August 17 and August 23, 2017, to discuss pathways for resolution of these deficiencies. 3 CHEMISTRY, MANUFACTURING, AND CONTROLS In the first cycle, 3M originally proposed an expiration date of 24 months, with impurity (b) (4) (b) limits of % total impurities and (4) % individual impurities. However, data demonstrate increasing amounts of degradants over time, with two impurities (b) (4) exceeding 1.0% at (b) (4) months, respectively. The 1.0% level is based on the ICH Q3B(R2)1, which sets limits for impurity specifications above which toxicology qualification is required. The sponsor subsequently proposed alternative analyses of (b) impurities and a shelf life of (4) months; however, these approaches failed to limit the impurities below the 1.0% level considered acceptable by ICH standards. A further (b) decrease in shelf life to below(4) months would not be acceptable from a clinical standpoint, because these products are stored in various hospital environments in which checking for expiration dates very frequently would likely pose an undue burden on the health care system and put patients at risk of use of expired product with untested impurities. 1 ICH Harmonized Tripartite Guideline: Impurities in New Drug Products Q3B(R2), Step 4 version dated 2 June 2006. Downloaded at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3B_R2/Step4/Q3B_R2__ Guideline.pdf 3 Reference ID: 4147866 Division Director Review NDA 208288 Chlorhexidine gluconate/isopropyl alcohol In this cycle, the sponsor submitted qualification data for these two impurities; however, the proposed specifications for these two impurities as well as the total impurities remained unacceptably high. Based on levels of impurities in the product real time stability data, the quality team recommended lowering the specifications, as follows: (b) (4) The sponsor accepted this recommendation. The quality team concluded that the application is potentially approvable, provided the specified levels are qualified. Control of overall impurities is especially important for an antiseptic product in which a lower concentration of the active ingredient (due to active ingredient degradation to form impurities) could result in decreased efficacy, leading to a higher incidence of surgical wound infections. (b) (4) The manufacturing quality microbiology review in the first cycle concluded that sterility of the finished product could not be assured due to a number of deficiencies. These included lack of validation data for the container closure integrity test,
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