FDA EXECUTIVE SUMMARY

April 22, 2002 Advisory Panel Discussion of CIU as an OTC Indication

The Advisory Committee meeting is being held on April 22nd, 2002, to discuss the issue of whether urticaria should be regarded as an over-the-counter (OTC) indication. The supplemental NDAs that raise this issue are from Schering-Plough. These sNDAs propose the switch of the Claritin (loratadine) line of products (single ingredient tablets, rapidly-disintegrating tablets and syrup) and combination products with pseudoephedrine (12-hour and 24-hour extended release tablets) to over-the-counter status. A previous meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee was held on May 11th, 2001 on the general safety of a switch of the newer-generation antihistamines to non-prescription status. The FDA received advice on loratadine being switched to OTC status for allergic rhinitis at that meeting and is not seeking further discussion of the issue at this time.

At the present time, oral antihistamines available OTC do not have an indication for hives (urticaria) or other skin conditions. Furthermore, there is no OTC drug specifically indicated for the treatment of "hives" in the U.S. (i.e., approving a product for OTC use for the treatment of hives would be a novel OTC indication).

Loratadine was granted an indication for Chronic Idiopathic Urticaria (or CIU) based on adequate and well-controlled trials of patients suffering from this condition, as a part of its prescription labeling. CIU is a complex entity that represents a syndrome of processes resulting in the manifestation of frequent, recurrent hives. CIU is a diagnosis of exclusion and the diagnosis itself must be made by trained health professionals. The FDA, in its presentation, plans to address the clinical profile of urticaria in general and CIU specifically, and the potential role of antihistamines in treating urticaria. The FDA will also address, as a part of its presentation, the details of how CIU indications are studied and granted for prescription antihistamine products, including loratadine.

In considering the chronic urticaria indication proposed by the sponsor, the committee will be asked to evaluate the information provided by the sponsor that assesses the ability of consumers to appropriately self-select and use the product based on the labeling (Drug Facts and Principle Display Panel). In proposing CIU as an OTC indication, the sponsor hopes to limit the OTC marketing of loratadine (aside from the rhinitis claims) to consumers with chronic hives previously diagnosed by a physician, a sub-population of consumers who experience urticaria. In support of this proposal, the sponsor has provided data from a consumer survey, a physician survey and a label comprehension study. The sponsor has also provided the recommendation from a panel of expert consultants to support this limited urticaria claim. All of this information is being provided to the committee along with FDA reviews.

The FDA presentation of the OTC issues related to the CIU claim will include:

In preparation for this advisory committee meeting, the committee members should review the data provided by the sponsor with the following questions in mind.

Based on the understanding of FDAs perspective on this disease and this proposed OTC indication and on the sponsors presentation of the data and perspective, the Advisory Committee will be asked to discuss and make recommendations on whether CIU or some broader urticaria indication should be granted to loratadine as a part of any OTC switch, and if so, if further data is needed to support a switch of this indication.