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Thursday, June 29, 2000 10:00 a.m.

Holiday Inn Bethesda Versailles I

8120 Wisconsin Avenue Bethesda, Maryland

Lynn A. Drake, M.D., Chairperson

Jaime Henriquez, Executive Secretary


Robert E. Jordan, M.D.

O. Fred Miller III, M.D. Robert S. Stern, M.D.


Wilma F. Bergfeld, M.D. Joan P. Chesney, M.D. John J. DiGiovanna, M.D.

James S. Kilpatrick, Jr., Ph.D. Joseph McGuire, M.D.

Joel Mindel, M.D., Ph.D. Eduardo Tschen, M.D. William Rosenberg, M.D.


Roselyn E. Epps, M.D. Mervyn Elgart, M.D.

Richard Steven Feldman, M.D., Ph.D. Lloyd E. King, Jr., M.D., Ph.D. Theodore Rosen, M.D.

Mary Spraker, M.D.


Jonathan K. Wilkin, M.D. Lois LaGrenade, M.D. Hon-Sum Ko, M.D.

Markham C.Luke, M.D., Ph.D. Martin Okun, M.D., Ph.D. Susan Walker, M.D.
3 C O N T E N T S

NDA 20-010 - Lotrisone (betamethasone diproprionate and clotrimazole) Lotion

Schering-Plough, Inc.

for Treatment of Tinea Pedis, Tinea Cruris and Tinea Corporis

Call to Order and Welcome: Lynn A. Drake, M.D. 5

Conflict of Interest Statement: Jaime Henriquez 5

Overview of the Issues: Jonathan Wilkin, M.D. 10

Presentations - FDA

Fixed Drug Products Combination Policy:

Antifungal Plus Corticosteroid for Tinea

Infections: Martin Okum, M.D., Ph.D. 11

NDA 20-010 Lotrisone Lotion:

Markham Luke, M.D., Ph.D. 63

Review of Lotrisone Adverse Events: 1984-1999:

Lois LaGrenade, M.D., M.P.H. 67

Recap: Markham Luke, M.D., Ph.D. 76

Presentations - Invited Experts

Perspectives on Topical Antifungal Therapy:

Theodore Rosen, M.D. 78

Open Public Hearing 95

Presentations - Invited Experts (Continued)

Tinea Incognito and Strong Topical Steroids:

Mervyn Elgart, M.D., Ph.D. 95

Use of Lotrisone in the United States:

Richard Steven Feldman, M.D. 105

Sponsor Presentation

Lotrisone Facts and Issues: Todd Plott, M.D. 135

Question for the Committee 166

5 C O N T E N T S(Continued)

NDA 20-996 - Dermex II (zinc oxinate) Ointment Dermex Pharmaceuticals, LLC

for Treatment of Actinic Keratosis, Basal Cell Carcinoma

and Squamous Cell Carcinoma

Conflict of Interest: Jaime Henriquez 223

Introductory Remarks: Jonathan Wilkin, M.D. 224

FDA Presentation

NDA 20-996 - Dermex (zinc oxinate) Ointment:

Hon-Sum Ko, M.D. 225

Sponsor Presentation

Summary of Company: Frank Potestio, M.D. 232

Updating Committee on Dermex: Carl Hanson 236

Committee Discussion 250
6 1 P R O C E E D I N G S

2 Call to Order and Welcome

3 DR. DRAKE: Good morning. I am Lynn Drake from

4 the University of Oklahoma, currently, and, as of July 1,

5 from Harvard Medical School. I would like to welcome you to

6 the fifty-second meeting of the Dermatologic and

7 Ophthalmologic Drugs Advisory Committee for the Center for

8 Drug Evaluation and Research of the Food and Drug

9 Administration. The date is June 29, 2000.

10 The first thing I would like to do, before

11 introductions, is make a primary introduction. I would like

12 to introduce our new executive secretary, Jaime Henriquez.

13 MR. HENRIQUEZ: Welcome.

14 Conflict of Interest Statement

15 MR. HENRIQUEZ: The following is the conflict of

16 interest statement. The following announcement addresses

17 the issues of conflict of interest with regards to this

18 meeting and is made a part of the record to preclude even

19 the appearance of such at this meeting.

20 Based on the submitted agenda and information

21 provided by the participants, the agency has determined that

22 all reported interests in firms regulated by the Center for

23 Drug Evaluation and Research present no potential for a

24 conflict of interest at this meeting with the following

25 exceptions.
7 1 In accordance with 18 USC 208-B, full waivers have

2 been granted to Drs. Joel Mindel and Robert S. Stern.

3 Copies of these waiver statements may be obtained by

4 submitting a written request to the FDA's Freedom of

5 Information Office located in 12A-30 in the Parklawn

6 Building.

7 In addition, we would like to disclose for the

8 record that Dr. Lynn Drake has interests which do not

9 constitute a financial interest within the meaning of 18 USC

10 208-A but which could create the appearance of a conflict.

11 The agency has determined, not withstanding these interests,

12 that the interests of the government and her participation

13 outweigh the concerns that the integrity of the agency's

14 programs and operations may be questioned.

15 With respect to the FDA's invited guest, Drs.

16 Stephen Feldman, Mervyn Elgart, Theodore Rosen and Mary

17 Spraker have reported interests which we believe should be

18 made public to allow the participants to objectively

19 evaluate their comments.

20 Dr Elgart would like the disclose that he speaks

21 for Vertex concerning Mentax. Dr. Feldman would like to

22 disclose that his Department of Dermatology received a

23 teaching grant from Ortho for Spectazole and a teaching

24 grant for Allergan grant for Naftin Cream and research

25 funding from Ortho from Spectazole Cream and NDA 21-026 His

8 1 department has also received similar research funding in the

2 past from Glaxo for Oxistate.

3 Dr. Theodore Rosen would like to disclose that his

4 department received a grant from Vertex for a study of

5 Mentax. Approximately six years ago, his department

6 received a grant from Allergan for a study of Naftin. Dr.

7 Rosen was an investigator on the study but received no

8 personal remunerations. Dr. Rosen has also given talks

9 concerning Mentax for Vertex and received speakers fees from

10 1998 through 2000. In 1999, Dr. Rosen received an

11 honorarium from Allergan for a lecture concerning Naftin.

12 Dr. Mary Spraker is an investigator on unrelated

13 studies for both Schering and Glaxo. In the event that the

14 discussions involve any other products or firms not already

15 on the agenda for which the FDA participants have a

16 financial interest, the participants are aware of the need

17 to exclude themselves from such involvement and their

18 exclusion will be noted for the record.

19 With respect to all other participants, we ask, in

20 the interest of fairness, that they address any current or

21 previous financial involvements with any firms whose

22 products they may wish to comment upon.

23 DR. DRAKE: Thank you.

24 The agenda is very busy this morning. It is a

25 very interesting agenda. The first thing I would like to do

9 1 is introduce the panel. I think most of us know each other

2 but there may be some who don't and there also may be people

3 in our audience who would like to know who the participants

4 are.

5 I guess I would like to start from this side of

6 the table with the FDA folks and we will wander around the

7 table. Please identify yourself and your affiliation.

8 DR. LaGRENADE: I am Lois LaGrenade with the

9 Office of Postmarket Drug Risk Assessment at the FDA. I am

10 a medical officer.

11 DR. OKUN: I am Marty Okun with the Division of

12 Dermatologic and Dental Drug Products, FDA.

13 DR. LUKE: Markham Luke with the FDA, Center for

14 Drug Evaluation and Research, Dermatologic Division.

15 DR. WILKIN: Jonathan Wilkin, Division Director,

16 Dermatologic and Dental Drug Products.

17 DR. MINDEL: Joel Mindel, Mt. Sinai School of

18 Medicine, Departments of Ophthalmology and Pharmacology.

19 DR. McGUIRE: Joe McGuire, Stanford, Dermatology

20 and Pediatrics.

21 DR. ROSENBERG: Bill Rosenberg, Dermatology at the

22 University of Tennessee.

23 DR. KILPATRICK: Jim Kilpatrick, Biostatistics,

24 Medical College of Virginia, Richmond, Virginia.

25 DR. STERN: Robert Stern, Dermatology at the Beth
10 1 Israel Deaconess Medical Center at Harvard Medical School.

2 MR. HENRIQUEZ: Jaime Henriquez, FDA.

3 DR. BERGFELD: Wilma Bergfeld, Cleveland Clinic,

4 Departments of Dermatology and Pathology.

5 DR. JORDAN: Bob Jordan, Dermatology, University

6 of Texas, Houston.

7 DR. MILLER: Fred Miller, Geisinger Medical

8 Center, Dermatology.

9 DR. DiGIOVANNA: John DiGiovanna, Dermatology,

10 Brown University and National Cancer Institute.

11 DR. TSCHEN: Eduardo Tschen, Dermatology,

12 University of New Mexico.

13 DR. DRAKE: This panel, just for the audience's

14 pleasure, are our invited experts. Please.

15 DR. EPPS: Roselyn Epps, Children's National

16 Medical Center, Washington, D.C.

17 DR. ROSEN: Ted Rosen, Department of Dermatology,

18 Baylor College of Medicine, Houston.

19 DR. FELDMAN: Steve Feldman, Department of

20 Dermatology and Pathology at Wake Forest University School

21 of Medicine.

22 DR. KING: Lloyd King, Vanderbilt University and

23 Nashville V.A., Dermatology and Dermatopathology.

24 DR. DRAKE: I would like to thank all the

25 committee and our experts for your time. I also want to
11 1 thank the FDA for the very nice presentations, that we have

2 received the documents ahead of time which is nice because

3 we have had an opportunity to review them and we look

4 forward to your presentations.

5 I guess we would like to start with Dr. Wilkin,

6 who is Chair of the Dermatologic and Opthalmologic Drugs

7 Division. Dr. Wilkin, would you give us an overview,

8 please, of what we discussing today.

9 Overview of the Issues

10 DR. WILKIN: Thank you, Dr. Drake. What we are

11 going to be looking at later this morning is Lotrisone

12 Lotion which is currently under review as an NDA in our

13 division. You will hear the regulatory history of Lotrisone

14 Lotion. You will learn that it received an approvable

15 letter in past. I can tell you that the sponsor has met the

16 conditions spelled out for approvability and so the intent

17 is, in the very near future, that I will be signing an

18 approval letter for this product.

19 This product is, of course, a line extension from

20 the Lotrisone Cream which has been of interest in the

21 literature to dermatologists and different comments have

22 been made. We have invited guests to speak to some of those

23 very specific Lotrisone-related issues.

24 What we hope to hear from the committee and also

25 from the guests is constructive suggestions for labeling

12 1 that might address some of these issues.

2 Before we get into the very specific aspects of

3 this particular antifungal corticosteroid combination

4 product, we would first like to begin the morning session

5 with an overview of antifungal/corticosteroid combination

6 product policy and ways of thinking about the attributes of

7 these products and how they might be labeled.

8 Again, in general, we will not be talking about a

9 specific product but I think those kinds of answers will

10 then help inform the specific questions that will follow on

11 this particular product.

12 DR. DRAKE: Thank you very much.

13 I think we will move, then, onto the main part of

14 the program. Dr. Okun, would you like to begin?

15 Presentations - FDA

16 Fixed Drug Products Combination Policy:

17 Antifungal Plus Corticosteroid for Tinea Infections

18 DR. OKUN: Good morning.

19 [Slide.]

20 As Dr. Wilkin indicated in his introduction, my

21 purpose here is to present an overview of how the agency's

22 combination policy is applied to topical drug products

23 containing an antifungal agent and a corticosteroid agent.

24 [Slide.]

25 First, I would like to define some symbols that

13 1 will be used in the presentation. AF+CS refers to a fixed-

2 drug combination topical drug product containing and

3 antifungal and a corticosteroid agent for treatment of tinea

4 infections. AF refers to a topical drug product containing

5 an antifungal agent. CS refers to a topic drug product

6 containing a corticosteroid agent.

7 [Slide.]

8 21 CFR 300.50 spells out the informational needs

9 for approval of fixed combination prescription drugs. Each

10 component of the combination must be shown to make a

11 contribution to the treatment effect. The dosage of each

12 component is such that the combination is safe and effective

13 for a patient population requiring combination therapy as

14 defined in the labeling of the product.

15 [Slide.]
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