Aquestive Therapeutics Completes CRL Remediation Studies for Anaphylm NDA Resubmission in Q3 2026

With human factors validation and pharmacokinetic data now in hand, Aquestive Therapeutics is positioned to resubmit its Anaphylm (dibutepinephrine) sublingual film NDA to the FDA before the close of Q3 2026, closing out the remediation cycle triggered by a Complete Response Letter dated January 30, 2026. For regulatory affairs teams managing CRL workflows, the program offers a concrete reference point on study sequencing and endpoint design under compressed timelines.

The CRL identified deficiencies in packaging design and human factors performance, along with pharmacokinetic data gaps. Aquestive's remediation addressed both in parallel. The human factors validation study evaluated a revised pouch opening, updated instructions for use, and modified pouch and carton labeling; results showed improvement across each deficiency cited. The PK study met its primary endpoints based on preliminary data, with no administration errors recorded in the self-administration arm and no serious adverse events or discontinuations. Critically, the FDA's original CRL raised no chemistry, manufacturing, or controls (CMC) deficiencies, and clinical comparability data against autoinjectors was not questioned, a distinction that narrows the resubmission scope and reduces the risk of additional review cycles.

Aquestive has confirmed it will request expedited review upon resubmission, though the agency is not obligated to grant a shortened timeline. Under 21 CFR Part 314, a Class 2 resubmission typically carries a six-month review clock from receipt; regulatory leads should plan resource allocation accordingly while monitoring for any agency communication that adjusts that cadence.

Pre-launch medical affairs activity and payer engagement are continuing in parallel, with the company targeting an allergist-focused initial commercial footprint if approval is secured. Ex-U.S. filings are on track to begin in Q4 2026, extending the regulatory workload into the next planning cycle. The broader AdrenaVerse epinephrine prodrug platform, including early-stage candidate AQST-108 for atopic dermatitis, remains in development with data readouts anticipated as the program moves toward 2027.

The completeness of the human factors package and the clean PK safety profile will be the primary determinants of whether the resubmission clears without a second CRL.

Source: Aquestive Therapeutics via GlobeNewswire, August 11, 2026. Investor call scheduled August 12, 2026, at 8:00 a.m. ET.