ARS Pharmaceutical Operations, Inc. — NEFFY® (epinephrine nasal spray) (2025-09-09)

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Silver Spring, MD 20993 Richard E. Lowenthal, MSc, MSEL

11682 El Camino Real Suite 120 San Diego, CA 92130

RE: NDA 214697 ® NEFFY (epinephrine nasal spray) MA 136

Dear Richard Lowenthal:

The U.S. Food and Drug Administration (FDA) has reviewed the promotional communication, ® a direct-to-consumer (DTC) broadcast advertisement (NEF-US-0507-1) (TV ad) for NEFFY (epinephrine nasal spray) (Neffy) submitted by ARS Pharmaceutical Operations, Inc. (ARS) under cover of Form FDA 2253. FDA has determined that the TV ad is false or misleading. Thus, the TV ad misbrands Neffy and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The TV ad includes the following claims (in pertinent part):

• “ No needles! Goodbye! ” (Jingle, 0:04 and 0:53) • “ Goodbye, needle fear. ” (Audio voiceover (VO), 0:25) • “ Goodbye needles. ” (SUPER, 0:58)

These claims are misleading because they suggest that patients will be able to completely avoid using any injectable treatments for emergency treatment of allergic reactions (i.e., say “ goodbye ” to needles) when this has not been demonstrated. According to the Patient Information for Neffy, “ When you have an allergic emergency (anaphylaxis)… Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy ” (emphasis original), which may require patients to receive an injectable product, such as epinephrine and/or other injectable treatments. These claims also misleadingly suggest that Neffy will eliminate patients’ concerns in terms of needle fear when this has not been demonstrated. FDA is unaware of any evidence to support suggestions that treatment with Neffy has an effect on needle fear or otherwise has a positive impact on a patient’s mental or emotional state regarding needles.

The TV ad also includes the following claims and presentations (in pertinent part):

• “ Hello, dining out. Goodbye, missing out. ” (VO, 0:18) • “ Hello, celebration. Goodbye, hesitation. ” (VO, 0:21) • Images of potential food allergens (e.g., birthday cake)

These claims and presentations are misleading because they suggest that Neffy alone can provide assurance that a patient with a history of life-threatening allergic reactions does not need to worry or take precautionary measures to avoid exposure to allergens. For example, the TV ad misleadingly suggests that a person who has food allergies can eat birthday cake or other food items with unknown ingredients and feel completely free from worry about any potential risk of anaphylaxis, provided they have access to Neffy, when this is not the case. In addition, the use of “ goodbye ” in these claims suggests that use of Neffy allows for the complete elimination of concerns about missing out on an event or hesitation around attending events. However, patients with severe allergies still must consider their particular situation in order to take appropriate precautionary measures to avoid allergen exposure and a potentially life-threatening anaphylactic reaction, regardless of access to Neffy treatment.

Conclusion and Requested Action

For the reasons described above, the TV ad misbrands Neffy and makes the distribution of the drug in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This letter notifies you of our concerns and provides you with an opportunity to address them. FDA requests that ARS take immediate action to address any violations (including, for example, ceasing and desisting promotional communications that are misleading as described above). Please submit a written response to this letter within 15 working days from the date of receipt, addressing the concerns described in this letter, listing all promotional communications (with the 2253 submission date) for Neffy that contain representations like those described above, and explaining your plan for the discontinuation of such communications, or for ceasing distribution of Neffy.

If you believe that your products are not in violation of the FD&C Act, please include in your submission to us your reasoning and any supporting information for our consideration within 15 working days from the date of receipt of this letter.

The concerns discussed in this letter do not necessarily constitute an exhaustive list of potential violations. It is your responsibility to ensure compliance with each applicable requirement of the FD&C Act and FDA implementing regulations.

Please direct your response to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-1266 . A courtesy copy can be sent by facsimile to (301) 847-8444. Please refer to MA 136 in addition to the NDA number in all future correspondence relating to this particular matter. All correspondence should include a subject line that clearly identifies the submission as a Response to Untitled Letter. You are encouraged, but not required, to submit your response in eCTD format. All correspondence submitted in response to this letter should be placed under eCTD Heading 1.15.1.6. Additionally, the response submission should be coded as an Amendment to eCTD Sequence 0241 under NDA 214697.

Questions related to the submission of your response letter should be emailed to CDER- OPDP-RPM@fda.hhs.gov .

Sincerely,

{See appended electronic signature page}

George Tidmarsh, M.D., Ph.D. Director Center for Drug Evaluation and Research

Signature Page 1 of 1 -------------------------------------------------------------------------------------------- This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record. -------------------------------------------------------------------------------------------- /s/ ------------------------------------------------------------

CARTER M BEACH 09/09/2025 05:07:21 PM On behalf of George Tidmarsh, M.D., Ph.D