Released by FDA: 8/13/01.  Posted by FDA:  9/14/01

Jan Tomsic
Director, Regulatory Affairs 
Connetics Corporation 
3400 West Bayshore Road 
Palo Alto, CA 94303

RE:   Luxig^TM (betamethasone valerate) Foam, 0.12% 
        NDA 20-934
        MACMIS ID#10224

Dear Ms. Tomsic:

This letter objects to Connetics Corporation's (Connetics) dissemination of violative promotional materials for Luxiq (betamethasone valerate) Foam.  As part of its monitoring program, the Division of Drug Marketing, Advertising and Communications (DDMAC) has become aware of direct-toconsumer (DTC) radio advertisements, professional promotional labeling, and website for Luxiq that are false or misleading, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.  The DTC broadcast radio advertisements ("Luxiq DTC Radio Campaign (CNX16825) Common problems-spot 1,2, and 3"), professional promotional labeling ("Luxiq 2001 Radio Campaign") and website (www.luxlq.com) submitted under FDA Form 2253 are violative for the reasons described below.

Overstatement of Efficacy

Luxiq's approved product labeling (PI) includes results from a clinical trial in 159 patients with moderate to severe scalp psoriasis demonstrating that Luxiq decreased scaling, erythema, and plaque thickness by 47%, 41 % and 66%, respectively.  In your advertisements, you present the claims "90-100% clearance in the majority of patients (72%) in 28 days, in a phase III clinical trial"  and  "Tests show that Luxiq provides rapid and highly effective relief in three out of four patients."   These claims are misleading because they are inconsistent with your PI and are an overstatement of the efficacy of Luxiq.

In addition, the trial described in the PI included patients who were treated twice daily for four weeks.  According to the PI, "At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Luxiq Foam in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion."   Your website includes the statements:

"How long will it take to see and feel results? Luxiq has been proven to deliver rapid and effective results.  In clinical trials, Luxiq reduced the signs and symptoms of skin irritation (scaling, redness, and plaques) within days of treatment."

These statements are misleading because they are inconsistent with the PI and overstate the efficacy of Luxiq with respect to how long it takes to see results.

Preference and Compliance Claims

Your advertisements include claims such as "In research with patients, more than 80% preferred foam over lotions, solution, gels, creams, ointments and oils," and  "80% of patients surveyed preferred Luxiq foam over lotions, gels and other treatments."   These claims are misleading because the references provided are insufficient to support these preference claims.  Specifically, outcomes claims, including product preference claims, require substantial evidence as measured by adequate and well-controlled trials using well-developed and validated measures.  Focus group research is not adequate and well-controlled.

Similarly, your claim "Patients prefer its quick-drying, stain-free and non-dripping qualities, which may enhance a patient's comfort and compliance" is misleading because the references provided are insufficient to support these claims.  These outcomes claims, i.e., enhanced comfort and enhanced compliance, require substantial evidence as measured by adequate and well-controlled trials using well-developed and validated measures.  The reference provided described only a theoretical discussion of these outcomes, not a study that actually measured them.

Superiority Claims

Your website contains the statements "Other scalp treatments such as ointments and solutions are oily, drippy, or messy, and may be inconvenient.  For all these reasons, you may find Luxiq better for you."   Similarly, your radio advertisement states "Every prescription scalp treatment I use has some kind of drawback.  The only way I'd try something new is if it were proven really safe and effective."   These presentations are misleading because they imply that Luxiq is superior to other products on the market when such has not been demonstrated by substantial evidence.  Your PI states that "At four weeks of treatment, study results of 159 patients demonstrated that the efficacy of Luxiq Foam in treating scalp psoriasis is superior to that of Placebo foam, and is comparable to that of a currently marketed BMV lotion (emphasis added)."

Requested Action

Connetics should immediately discontinue these and all other promotional materials and activities for Luxiq that contain the same or similar claims or presentations.  We request that Connetics respond, in writing, with its intent to comply with the above.  DDMAC should receive your written response no later than August 22, 2001.  This response should list similarly violative materials with a description of the method for discontinuation and the discontinuation date.

If you have any questions or comments, please contact me by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD42, Rm. 1713-20, 5600 Fishers Lane, Rockville, MD 20857.  DDMAC reminds you that only written communications are considered official.

In all future correspondence regarding this particular matter, please refer to MACMIS ID #10224 in addition to the NDA number.

Sincerely,

 

Barbara S.. Chong, Pharm.D., BCPS 
Regulatory Review Officer 
Division of Drug Marketing, 
    Advertising and Communications