Anaphylm human factors validation study

13 evidence topics · 3 sources

Objective

Evaluation of a revised packaging design and instructions for use

“The new HF study evaluated a revised packaging design, incorporating modifications to the pouch opening, instructions for use, and pouch and carton labeling intended to address previously identified issues.” (opens the source at this quote in a new tab)

Use-related deficiencies identified by the FDA that the study addressed

“Specifically, the Company received a Complete Response Letter (CRL) from the FDA in January 2026 which indicated that, in a previous human factors study, participants had difficulty opening the pouch, tore the film during pouch opening, incorrectly placed the film during administration, chewed the film, and/or removed the film after administration.” (opens the source at this quote in a new tab)

Location and study date

Topline results reported in August 2026

“Human factors and clinical study results support planned resubmission of Anaphylm™ NDA in the third quarter of 2026” (opens the source at this quote in a new tab)

Study design

User groups and protocol agreed with the FDA

“The FDA recommended changes to the user groups to be included in the HF study design and, after discussion at the Type A meeting, the Company believes there is general alignment with the FDA on key HF study elements. Aquestive plans to submit the HF study protocol for FDA review, as recommended by the FDA.” (opens the source at this quote in a new tab)

Container closure revisions tested in the study

“During the meeting, the Company shared with the FDA the revisions made to the opening mechanisms of the product container closure, which were designed to provide improvements in the ability to open the pouch while also mitigating the potential tearing of the film. The FDA acknowledged the changes made to the Anaphylm container closure, which will be tested in the Company’s upcoming HF study.” (opens the source at this quote in a new tab)

Eligibility criteria

No evidence found.

Treatment

Revised packaging, instructions for use, and labeling

“In response to the CRL, Aquestive completed a human factors study evaluating revised packaging that incorporated modifications to the pouch opening, instructions for use, and pouch and carton labeling.” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using observed use errors as the primary endpoint

Use errors mapped to the deficiencies named in the Complete Response Letter

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

Pouch-opening time and film placement as reported endpoints

“Revised packaging design reduced median time to open pouch from 17 seconds in the previous human factors study to 3 seconds” (opens the source at this quote in a new tab)
“Revised instructions for use reduced incorrect film placement from previous human factors validation study by over 80%” (opens the source at this quote in a new tab)

Statistical analysis description

Number of participants (Planned and analyzed)

Participants in the previous and the revised human factors studies

“The number of participants who had difficulty opening the pouch decreased from 26 (out of 166) to 1 (out of 105).” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

Use errors observed with the revised packaging and instructions for use

“The median time to open a pouch decreased from 17 seconds in the previous study to 3 seconds. The number of participants who had difficulty opening the pouch decreased from 26 (out of 166) to 1 (out of 105). The number of participants who incorrectly administered the film in the mouth decreased from 20 (out of 166) to 2 (out of 105). In the latest HF study, no participants were observed chewing the film or removing the film.” (opens the source at this quote in a new tab)

Pouch-opening time reported at resubmission

“The completed studies generated human factors, pharmacokinetic, and pharmacodynamic data supporting the revised packaging design and instructions for use, including reducing median pouch-opening time from 17 seconds to 3 seconds.” (opens the source at this quote in a new tab)

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

Film retention during the study

“From a tolerability perspective, there were no participants in the HF study and no subjects in the PK study who prematurely removed the film.” (opens the source at this quote in a new tab)

Study limitations

Summary: study limitations

The comparison of 105 participants in the revised study with 166 participants in the earlier study is a comparison across two separate human factors studies rather than a randomized within-study comparison, and the user groups differed after the FDA recommended changes to them. Simulated-use testing measures handling of the packaging under observation and does not establish behaviour during an actual allergic reaction. Only topline counts have been released, with no report of the full set of use errors, the task analysis, or the participant characteristics, and the results have not been published or registered.