Susan Rinne
Vice President, Regulatory Affairs
NeurogesX, Inc.
2215 Bridgepointe Parkway
San Mateo, CA 94404-5067

RE: NDA # 022395
      QUTENZA® (capsaicin) 8% patch
      MA # 22

Dear Ms. Rinne:

The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed an exhibit booth (Q2010050) for QUTENZA® (capsaicin) 8% patch (Qutenza) submitted by NeurogesX, Inc. (NeurogesX) under cover of Form FDA 2253. The exhibit booth was displayed at the American Academy of Nurse Practitioners meeting held in Las Vegas, Nevada, on June 22-26, 2011, and viewed individually by three OPDP representatives at three separate times. The exhibit booth is false or misleading because it presents efficacy claims for Qutenza but fails to communicate information about the risks associated with its use. The exhibit booth therefore misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 352(a) and 321(n). Cf. 21 CFR 202.1(e)(5).

Background

Below is the indication and summary of the most serious and most common risks associated with the use of Qutenza.¹

According to its FDA-approved product labeling (PI), Qutenza is indicated for the management of neuropathic pain associated with postherpetic neuralgia.

The PI for Qutenza includes warnings and precautions regarding eye and mucous membrane exposure, aerosolization of capsaicin, unintended skin exposure, application associated pain, and increase in blood pressure. The most common adverse reactions (>_5% and greater than control) are application site erythema, application site pain, application site pruritus, and application site papules.

De Facto Omission of Risk Information

Promotional materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.

The exhibit booth prominently presented a panel with effectiveness claims for Qutenza which were clearly visible to viewers. However, the exhibit booth failed to communicate risk information associated with the use of Qutenza. Specifically, the risk information included in the exhibit booth was not visible to viewers as a practical matter. As witnessed individually by three OPDP representatives on three separate occasions, the risk information was presented on the bottom of the display panels, behind bags, boxes, and other materials; thus it was completely obscured from view and inaccessible to viewers. Presenting risk information in this manner is not sufficient to ensure that the claims in the exhibit booth are truthful and non-misleading. Thus, the exhibit booth presentation misleadingly suggested that Qutenza is safer than has been demonstrated by substantial evidence or substantial clinical experience.

Conclusion and Requested Action

For the reasons discussed above, the exhibit booth misbrands Qutenza in violation of the FD&C Act, 21 U.S.C. 352(a) and 321(n), and FDA implementing regulations. Cf. 21 CFR 202.1(e)(5).

OPDP requests that NeurogesX immediately cease the dissemination of violative promotional materials for Qutenza such as those described above. Please submit a written response to this letter on or before December 27, 2011, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Qutenza that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials.

Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, Division of Professional Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 or by facsimile at (301) 847-8444. Please note that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has been reorganized and elevated to the Office of Prescription Drug Promotion (OPDP). OPDP consists of the Immediate Office, the Division of Professional Promotion (DPP) and the Division of Direct-to-Consumer Promotion (DDTCP). To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g., a sticker) to indicate that the submission is intended for OPDP. In addition, OPDP recently migrated to a different tracking system. Therefore, OPDP letters will now refer to MA numbers instead of MACMIS numbers. Please refer to the MA # in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Qutenza comply with each applicable requirement of the FD&C Act and FDA implementing regulations.

Sincerely,

Twyla Thompson, Pharm.D.
Regulatory Review Officer
Division of Professional Promotion
Office of Prescription Drug Promotion