CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204442Orig1s000 PROPRIETARY NAME REVIEW(S) MEMORANDUM REVIEW OF PROPRIETARY NAME Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) Date of This Memorandum: February 18, 2016 Requesting Office or Division: Division of Anesthesia, Analgesia, and Addiction Products (DAAAP) Application Type and Number: NDA 204442 Product Name and Strength: Probuphine (buprenorphine) implant, 74.2 mg Submission Date: February 16, 2016 Applicant/Sponsor Name: Titan Pharmaceuticals, Inc. OSE RCM #: 2016-2818361 DMEPA Primary Reviewer: Millie Shah, PharmD, BCPS DMEPA Team Leader: Vicky Borders-Hemphill, PharmD 1 PURPOSE OF MEMO This memorandum is to re-assess the proposed proprietary name, Probuphine, based on the revised strength. The proposed name, Probuphine, was found acceptable in OSE review # 2015-1601445 dated December 8, 20151 and OSE review #2012-2724 dated February 11, 2013.2 The established name of the product was originally presented as the salt, buprenorphine hydrochloride, with the strength of 80 mg per implant. Based on the recommendation by the Office of Product Quality, Titan Pharmaceuticals revised the 1 Shah M. Proprietary Name Review for Probuphine (NDA 204442). Silver Spring (MD): Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis (US); 2015 Dec 08. 68 p. OSE RCM No.: 2015-1601445. 2 Borders-Hemphill V. Proprietary Name Review for Probuphine (NDA 204442). Silver Spring (MD): Food and Drug Administration, Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology, Division of Medication Error Prevention and Analysis (US); 2013 FEB 11. 32 p. OSE RCM No.: 2012-2724. 1 Reference ID: 3889206 strength of the product to reflect the active moiety, buprenorphine, as the established name with the revised implant strength of 74.2 mg. 2 METHODS AND MATERIALS REVIEWED For reassessment of the proposed proprietary name, we evaluated previous proprietary name reviews dated December 8, 2015 and February 11, 2013 to assess whether the change in strength would alter our previous conclusion regarding the acceptability of the proposed proprietary name. We searched the USAN stem list to determine if the name contains any USAN stems as of the last USAN updates.3 Our search did not identify any USAN stems present in the proprietary name. We evaluated the results of our previous POCA search in OSE review #2015-16014454 to identify names with overlapping strength and/or dose with the new 74.2 mg strength. Our search did not identify any names with an overlap in strength and/or dose with the 74.2 mg strength. Additionally, since Probuphine is being proposed in a strength that is not commonly marketed, we searched the Electronic Drug Registration and Listing System (eDRLS) database to identify any names with potential orthographic, spelling, and phonetic similarities with Probuphine that were not identified in POCA, and found to have an overlap in strength with Probuphine.5 Our search did not result in any names. Our USAN stem search, evaluation of previous POCA search results, and eDRLS search did not identify any new names that represent a potential source of drug name confusion. Our evaluation has not altered our previous conclusion regarding the acceptability of the proposed proprietary name. As a result, we maintain that the name is acceptable. 3 CONCLUSIONS The proposed proprietary name is acceptable. If you have further questions or need clarifications, please contact Davis Mathew, OSE Project Manager, at 240-402-4559. 4 COMMENTS TO APPLICANT We have completed the re-evaluation of the proposed proprietary name, Probuphine, and have concluded that this name is acceptable. 3 USAN stem search conducted on February 16, 2016. 4 POCA search conducted on October 14, 2015. 5 eDRLS search conducted on February 16, 2016. 2 Reference ID: 3889206 5 REFERENCES 1. USAN Stems (http://www.ama-assn.org/ama/pub/physician-resources/medical- science/united-states-adopted-names-council/naming-guidelines/approved-stems.page) USAN Stems List contains all the recognized USAN stems. 2. Phonetic and Orthographic Computer Analysis (POCA) POCA is a system that FDA designed. As part of the name similarity assessment, POCA is used to evaluate proposed names via a phonetic and orthographic algorithm. The proposed proprietary name is converted into its phonemic representation before it runs through the phonetic algorithm. Likewise, an orthographic algorithm exists that operates in a similar fashion. POCA is publicly accessible. 3. Electronic Drug Registration and Listing System (eDRLS) database The electronic Drug Registration and Listing System (eDRLS) was established to supports the FDA’s Center for Drug Evaluation and Research (CDER) goal to establish a common Structured Product Labeling (SPL) repository for all facilities that manufacture regulated drugs. The system is a reliable, up-to-date inventory of FDA-regulated, drugs and establishments that produce drugs and their associated information. 3 Reference ID: 3889206 --------------------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature. --------------------------------------------------------------------------------------------------------- /s/ ---------------------------------------------------- MILLIE C BRAHMBHATT 02/18/2016 BRENDA V BORDERS-HEMPHILL 02/18/2016 Reference ID: 3889206 PROPRIETARY NAME REVIEW Division of Medication Error Prevention and Analysis (DMEPA) Office of Medication Error Prevention and Risk Management (OMEPRM) Office of Surveillance and Epidemiology (OSE) Center for Drug Evaluation and Research (CDER) *** This document contains proprietary information that cannot be released to the public*** Date of This Review: December 8, 2015 Application Type and Number: NDA 204442 Product Name and Strength: Probuphine (buprenorphine HCl) implant 80 mg implant Product Type: Single ingredient Rx or OTC: Rx Applicant/Sponsor Name: Titan Pharmaceuticals, Inc. Panorama #: 2015-1601445 DMEPA Primary Reviewer: Millie Shah, PharmD, BCPS DMEPA Team Leader: Vicky Borders-Hemphill, PharmD Reference ID: 3857515 Contents 1 INTRODUCTION........................................................................................................1 1.1 Regulatory History................................................................................................1 1.2 Product Information ..............................................................................................1 2 RESULTS.....................................................................................................................1 2.1 Misbranding Assessment ......................................................................................1 2.2 Safety Assessment.................................................................................................2 3 CONCLUSIONS..........................................................................................................4 3.1 Comments to the Applicant...................................................................................5 4 REFERENCES.............................................................................................................6 APPENDICES .....................................................................................................................7 Reference ID: 3857515 1 INTRODUCTION This review evaluates the proposed proprietary name, Probuphine, from a safety and misbranding perspective. The sources and methods used to evaluate the proposed name are outlined in the reference section and Appendix A respectively. The Applicant did not submit an external name study for this proposed proprietary name. 1.1 REGULATORY HISTORY The Applicant previously submitted the proposed proprietary name, Probuphine on November 15, 2012. The Division of Medication Error Prevention and Analysis (DMEPA) found the name, Probuphine acceptable in OSE Review #2012-27241, dated February 11, 2013. Given the time that has elapsed, the Applicant submitted the name, Probuphine, for review on September 30, 2015. 1.2 PRODUCT INFORMATION The following product information is provided in the September 30, 2015 proprietary name submission. Intended Pronunciation: pro-bu-feen Active Ingredient: buprenorphine hydrochloride Indication of Use: maintenance treatment of opioid dependence Route of Administration: subdermal Dosage Form: implant Strength: 80 mg Dose and Frequency: 4 implants inserted subdermally once, and then removed after 6 months. Therapy may continue after 6 months with insertion of new implants How Supplied: One Probuphine carton consists of four individually packaged sterile implants. Each implant is 26 mm in length and 2.5 mm in diameter and contains 80 mg of buprenorphine. Each package contains the four-pouched implants and one sterile, disposable applicator packaged in a (b) (4) pouch. Storage/Container Closure System: Store PROBUPHINE at 20 to 25°C (68 to 77°F); excursions permitted at 15 to 30°C (59-86°F) [see USP Controlled Room Temperature]. 2 RESULTS 1 Borders-Hemphill V. Proprietary Name Review for Probuphine (NDA 204442). Silver