AcelRx Pharmaceuticals, Inc.: DSUVIA

Cosmetic Act (FDCA) for DSUVIA (sufentanil sublingual tablet).

We have determined that the human factors (HF) validation study data did not demonstrate that the user interface supports safe and effective use of the product by intended users for intended uses and environments.

Failures that result in dropped sufentanil tablets pose a risk for accidental exposure, improper dosing, and diversion.

Develop mitigation strategies to address the risk of dropped sufentanil tablets.

2. Modify the figures that depict the patient's mouth by labeling parts of the mouth so they represent a more accurate representation of human anatomy.

Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks[section 505-1(a)].

The REMS, should it be approved, will create enforceable obligations.

We reserve final comment on the proposed container label and carton labeling until the application is otherwise adequate.

We recommend the proprietary name "DSUVIA" is presented in all the same color without any intervening matter.

Our ongoing review of these citizen petitions does not change DAAAP's decision to issue a complete response for the application that is the subject of this letter.