Released by FDA: 11/3/99.  Posted by FDA: 12/15/99

Carol Karp 
Vice President, Regulatory Affairs 
VIVUS, Inc. 
605 East Fairchild Drive 
Mountain View, CA 94043

RE:    NDA 20-700 
         MUSE (alprostadil) urethral suppository 
         MACMIS ID #6925

Dear Ms. Karp:

As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has become aware of promotional labeling for MUSE (alprostadil) urethral suppository, disseminated by VIVUS, Inc. (VIVUS) that is in violation of the Federal Food, Drug and Cosmetic Act and its implementing regulations.  Specifically, we refer to a promotional brochure, submitted by Vivus on Form FDA 2253, for MUSE entitled “Another meaning for the phrase SAFE SEX....”  DDMAC objects to the brochure for the following reasons.

“Another meaning for the phrase SAFE SEX. ..MUSE (alprostadil) urethral suppository”

This claim is presented prominently on the front cover of your promotional brochure in large, bolded typeface and represents the title of the promotional brochure.  Your implication that MUSE is associated with “SAFE SEX” is misleading.  We refer you to the approved product labeling (PI) for MUSE, which states “Patients should be informed that MUSE offers no protection from the transmission of sexually transmitted diseases.  Patients and partners who use MUSE need to be counseled about the protective measures that are necessary to guard against the spread of sexually transmitted agents, including the human immunodefficiency virus (HIV).”  The brochure fails to include this risk information.  Moreover, your subsequent presentation of risks associated with MUSE therapy, including the potential for priapism, symptomatic hypotension, and syncope are minimized by this misleading message of “safe sex."

“When considering treatment options for your patients with impotence, think of SAFETY.”

“MUSE is a local treatment option designed to minimize the risks that may be associated with systemic therapy for impotence.”

These claims are misleading because they suggest that MUSE is safer, has fewer, or less incidence of, or less serious side effects, than other treatment options for erectile dysfunction (ED) because it is a “local treatment.”  This suggestion is reinforced by your presentation of selected statements such as “no increased cardiovascular risk associated with sexual intercourse.”  This presentation suggests that MUSE may be used without caution in patients with cardiovascular disease, when, in fact, the PI includes a warning concerning the potential for symptomatic hypotension and syncope in patients treated with MUSE.  In addition, the PRECAUTIONS section of the PI states “Sexual intercourse is considered a vigorous physical activity, and it increases heart rate as well as cardiac work.  Physicians may want to examine the cardiac fitness of patients prior to treating erectile dysfunction.”  Finally, you have not demonstrated that MUSE’s safety profile is superior to other treatment options for ED as the brochure suggests.

In order to address these violations, DDMAC recommends that Vivus take the following actions:

1. Immediately discontinue the use of this brochure, and all other promotional materials for MUSE that contain the same or similar violations.

2. Provide to DDMAC, in writing, Vivus’ intent to comply with #1 above.  Your response should be received by November 17, 1999.

3. This response should include the date that the brochure was discontinued, and a list of all similarly violative promotional materials and Vivus’ method for discontinuing their use.

If you have any questions or comments, please contact the undersigned by facsimile at (301) 594-6771, or at the Food and Drug Administration, Division of Drug Marketing, Advertising and Communications, HFD-42, Rm. 17B-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 #6925 in addition to the NDA number.

Sincerely,

 

Mark W. Askine, R.Ph. 
Regulatory Review Officer 
Division of Drug Marketing, 
  Advertising and Communications