Evicenter
P&T meetings

Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Regulatory submission
NDA resubmitted September 2026
Launch
Not announced
Last updated
121 sources

Product information and disease descriptionProduct description

Phase of product development

11 evidence topics · 8 sources

Regulatory submission: NDA resubmitted September 2026

“today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis.” (opens the source at this quote in a new tab)

“Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026” (opens the source at this quote in a new tab)

Launch

No evidence found.

Investigational status

“ANAPHYLM (dibutepinephrine) sublingual film is an investigational product candidate that has not been approved by the U.S. Food and Drug Administration.” (opens the source at this quote in a new tab)

“Anaphylm™ (dibutepinephrine) sublingual film is a polymer matrix-based epinephrine prodrug investigational product.” (opens the source at this quote in a new tab)

Regulatory pathway: 505(b)(2) and Fast Track designation

“The FDA confirmed that the 505(b)(2) regulatory approval pathway is acceptable for the development of Anaphylm. The FDA granted Fast Track designation of Anaphylm in March 2022.” (opens the source at this quote in a new tab)

Orphan drug, breakthrough therapy, and priority review designations

No evidence found.

Original New Drug Application submission, filing acceptance, and PDUFA date

“The Company’s original NDA for Anaphylm was submitted in March 2025.” (opens the source at this quote in a new tab)

“Aquestive completed the Anaphylm NDA submission to the FDA in the first quarter of 2025. On June 16, 2025, the NDA submission was accepted by the FDA and a PDUFA target action date of January 31, 2026 was assigned.” (opens the source at this quote in a new tab)

“has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026” (opens the source at this quote in a new tab)

Advisory committee meeting

“The Company was informed in September that the FDA would not hold an Advisory Committee meeting regarding the approval of Anaphylm.” (opens the source at this quote in a new tab)

Complete Response Letter dated January 30, 2026

“today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 for the New Drug Application (NDA) seeking approval of Anaphylm™ (dibutepinephrine) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more (approximately 66 pounds).” (opens the source at this quote in a new tab)

“In the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors (HF) validation study.” (opens the source at this quote in a new tab)

“Due to the requirements related to HF, clinical pharmacology requested a single pharmacokinetics (PK) study to understand the impact of any modifications to packaging and labeling. The Agency indicated that the HF and PK studies can be conducted in parallel. No additional studies were requested in the CRL.” (opens the source at this quote in a new tab)

“There were also no CMC issues noted in the CRL.” (opens the source at this quote in a new tab)

“The FDA issued a Complete Response Letter (CRL) on January 30, 2026, which requested that the Company complete a human factors study addressing packaging and administration, and a confirmatory pharmacokinetic (PK) study of Anaphylm.” (opens the source at this quote in a new tab)

Type A meeting completed March 2026

“today announced the receipt of preliminary comments and successful completion of an in-person Type A meeting with the U.S. Food and Drug Administration (FDA) regarding the resubmission of the Company's New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film” (opens the source at this quote in a new tab)

“In addition, the Company and FDA aligned on the concept of including labeling language to manage potential chewing of the film rather than creating additional clinical data.” (opens the source at this quote in a new tab)

“Based on the outcome of the Type A meeting, Aquestive reaffirms its guidance to resubmit the Anaphylm NDA in the third quarter of 2026.” (opens the source at this quote in a new tab)

“Following receipt of the CRL, Aquestive held a Type A meeting with the FDA to discuss the Company’s proposed approach to addressing the matters identified in the CRL.” (opens the source at this quote in a new tab)

Topline human factors and pharmacokinetic results announced August 2026

“The new HF study shows significant improvement across each deficiency identified by the FDA.” (opens the source at this quote in a new tab)

“The median time to open a pouch decreased from 17 seconds in the previous study to 3 seconds.” (opens the source at this quote in a new tab)

“No administration errors were observed in the self-administration arm of the PK study.” (opens the source at this quote in a new tab)

“No protocol-defined use errors were observed in the self-administration arm of the PK study.” (opens the source at this quote in a new tab)

Expected review classification and timeline for the resubmission

“FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission” (opens the source at this quote in a new tab)

“The Company will request an expedited review upon resubmission, though no shortened or expedited review timeline can be guaranteed.” (opens the source at this quote in a new tab)

Regulatory filings outside the United States

“The Company remains on track to submit regulatory applications in Canada by the end of 2026 and in the European Union in the first quarter of 2027. The Company expects its existing clinical data to support regulatory submissions in additional markets in 2027, including the United Kingdom.” (opens the source at this quote in a new tab)

“The Company received positive feedback from the European Medicines Agency (EMA) that no further clinical trials are needed prior to regulatory approval submission.” (opens the source at this quote in a new tab)

“Ex-US expansion is on track – filing in Canada before the end of 2026 and the filing in the E.U. in Q1 2027” (opens the source at this quote in a new tab)

Citizen petitions relating to Anaphylm

“risks that the FDA may consider issues raised in the citizen petition submitted to the FDA regarding Anaphylm on October 1, 2025” (opens the source at this quote in a new tab)

“the risk that the FDA may consider issues raised in one or more citizen petitions or similar submissions relating to Anaphylm” (opens the source at this quote in a new tab)