Released by FDA: 12/8/00.  Posted by FDA:  12/15/00

Mary Jane Nehring 
Director, Marketed Products Support 
Worldwide Regulatory Affairs 
Schering Corporation 
2000 Galloping Hill Road 
Kenilworth. New Jersey 07033

NDA   #20-762 
Nasonex® (mometasone furoate monohydrate) Nasal Spray 
MACMIS # 9001

Dear Ms. Nehring:

This letter concerns Schering Corporation's(Schering) dissemination of promotional materials for Nasonex (mometasone furoate monohydrate) Nasal Spray.  Through routine monitoring and surveillance, the Division of Drug Marketing. Advertising, and Communications (DDMAC) has become aware of promotional materials that contain false or misleading presentations, in violation of the Federal Food, Drug, and Cosmetic Act and implementing regulations.  The specific materials are identified as physician letter NX0895, sales aids NX0747 and NX0876.  Our specific objections follow.

Unsupported Claims of Superiority

Promotional material is false or misleading if it contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug when such has not been demonstrated by substantial evidence.

Your letter and sales aids contain two graphical presentations comparing mometasone furoate (Nasonex) with fluticasone propionate (FP) and placebo.  One presentation is that of a bar graph depicting that more patients had complete or marked relief with Nasonex than with FP.  The other graph shows that more patients had total nasal symptoms improve with Nasonex than with FP.  These presentations are misleading because they suggest that Nasonex is more effective than FP when such has not been demonstrated by substantial evidence.  In this case, your presentations are based on selected secondary endpoints from a study by Mandl, et al., referenced as “Comparison of Once-Daily Mometasone Furoate (Nasonex) and Fluticasone Propionate Aqueous Nasal Sprays for the Treatment of Perennial Rhinitis", Annals of Allergy, Asthma, & Immunology, 79:370-379, 1997.  The primary objective of the study was to compare the effectiveness and tolerability of’ Nasonex to placebo and to FP.   The primary efficacy variable was the change from baseline in total AM plus PM nasal symptom score over the first 15 days of’ treatment based on patient diaries.  For the primary efficacy variable, Nasonex was no different from FP.  Thus, your suggestion that Nasonex is superior to FP is misleading.

DDMAC is concerned that. iii spite of past regulatory action concerning similar violative superiority presentations based on the Mandl Study (untitled letter dated June 24, 1995).   Schering continues to misleadingly suggest that Nasonex is clinically superior to FP.

Minimization of Risk Information and Lack of’ Fair Balance

Promotional material is false, lacking in fair balance, or otherwise misleading if if fails to provide sufficient emphasis for information relating to risks associated with the use of the product.  Risk information should be presented with a prominence and readability reasonably comparable with the presentation of information relating to the effectiveness of the drug.

Nasonex’s approved product labeling (P1) contains important risk information relating to the possibility of the occurrence of adrenal insufficiency if a topical corticosteroid is used to replace a systemic corticosteroid.  This information appears in the WARNING section of’ the P1.  In sales aid NX0876 this warning appears once, in small type on the back page.  The placement and prominence of this risk information minimizes its importance.  Furthermore, the presentation of the adverse event information is also not presented with a prominence and readability reasonably comparable to the presentation of efficacy claims, taking into account all techniques apt to achieve emphasis.

Requested Action

Sehering should immediately discontinue these and all other promotional materials for Nasonex that contain the same or similar violations.  We request that Schering respond. in writing, with its intent to comply with the above.  This response should list similarly violative materials with a description of the method for discontinuation and the discontinuation date.  DDMAC should receive this response by December 22, 2000.

If you have any questions or comments, you may contact me by facsimile at 301-594-6759 or at the Food and Drug Administration, Division of Drug Marketing, Advertising, and Communications, HFD-42, Room 1713-20, 5600 Fishers Lane, Rockville,  MD 20857.  We remind you that only written communications are considered official.

In all future correspondences regarding this particular matter. please refer to MAMCMIS # 9001 in addition to the NDA number.

Sincerely,

 

Laurie Lenkel, R.Ph., J.D.
Regulatory Review Officer
Division of Drug Marketing,
  Advertising, and Communications