Anaphylm (epinephrine) / Aquestive - LARVOL DELTA

Aquestive Therapeutics Announces Resubmission of New Drug Application to FDA for Anaphylm Sublingual Film (Investing News Network (INN)) - "Resubmission supported by positive topline human factors and pharmacokinetic (PK) study results announced in August 2026; FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission."

FDA filing • Allergy • Immunology

Non-CME Corporate Forum - Aquestive Therapeutics, Inc. : Sublingual Epinephrine and Meeting the Unmet Need in Anaphylaxis Care (ACAAI 2026) - "We will discuss the unmet need in anaphylaxis treatments; AQST-109 clinical program; and how this novel treatment may address this unmet need. Also visit Aquestive Therapeutics, Inc. at Booth #1234."

Pharmacokinetics and pharmacodynamics of AQST-109 sublingual film in oral allergy syndrome: A phase 2 study. (PubMed, Ann Allergy Asthma Immunol) - "AQST-109 PK and PD are not diminished with oral symptoms and changes, supporting reliable absorption in allergic reactions with such contexts."

Journal • P2 data • PK/PD data • Allergy • Cardiovascular • Immunology

Aquestive Therapeutics Announces Completion of Type A Meeting with FDA for Anaphylm (dibutepinephrine) Sublingual Film (The Manila Times) - "Aquestive provided the proposed PK study design to the FDA prior to the Type A meeting and received preliminary comments in advance of the meeting. Most of the preliminary comments provided by the FDA were focused on ensuring consistency between past PK studies conducted by the Company and the proposed current design...Based on the outcome of the Type A meeting, Aquestive reaffirms its guidance to resubmit the Anaphylm NDA in the third quarter of 2026."

FDA event • FDA filing • Allergy • Immunology

Novel Sublingual Epinephrine Is Not Associated with a Diastolic Blood Pressure Dip (AAAAI 2026) - "Methods Analysis of data from one pivotal, open-label, single-dose trial compared PD profiles of Anaphylm™ (dibutepinephrine) sublingual film, epinephrine 0.3 mg manual IM injection, EpiPen® 0.3 mg, and Auvi-Q® 0.3 mg in 64 healthy volunteers...Due to sublingual administration, Anaphylm likely bypasses β2-driven vasodilation that can lead to transient hypotension with IM administration. This may potentially support better clinical outcomes in patients with distributive shock."

Hypotension

Epinephrine Plasma Concentration and Hemodynamic Threshold Response Following Novel Sublingual Epinephrine Administration (AAAAI 2026) - "Conclusions Our data suggest there is no direct association between plasma epinephrine concentrations and elevations in HR, SBP or DBP attributable to higher concentrations following Anaphylm administration. These findings suggest that plasma epinephrine concentrations do not correlate with greater hemodynamic effects within ranges observed in this study population."

Allergy • Immunology

Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm (GlobeNewswire) - "In the CRL, which focuses on administration and labeling guidance, the FDA cited deficiencies in the Anaphylm human factors (HF) validation study. These included instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis...The Company also plans to further address potential tolerability issues in its resubmission. Comparability data submitted as part of the Anaphylm NDA, such as bracketing, repeat dose, and sustainability, were not questioned in the CRL....Based on its initial review of the CRL, the Company estimates resubmission in Q3 2026, assuming completion of the HF and PK studies and typical response times from the FDA."

CRL • FDA filing • Allergy

Aquestive also plans to continue advancing its global expansion strategy for Anaphylm, having initiated regulatory engagements in Canada, Europe, and the United Kingdom in 2025. (GlobeNewswire) - "Aquestive expects to submit its marketing authorization application in Europe as well as its New Drug Submission (NDS) in Canada in the second half of 2026. The Company also expects to receive feedback from the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in the first quarter of 2026."

Filing • Allergy

Aquestive Therapeutics Announces Regulatory Development for Anaphylm Sublingual Film and Provides Business Update (Investing News Network (INN)) - "Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at this time; Receives confirmation from FDA that Agency's review of Anaphylm NDA application is ongoing and no final FDA decision has been made...'We are advancing our global expansion of Anaphylm with plans to submit for regulatory approval in Canada, Europe, and the United Kingdom in 2026.'...The Company is in contact with the U.S. Food and Drug Administration (FDA) to gather further information about the deficiencies presently identified by the FDA in the New Drug Application (NDA) for Anaphylm, with the goal of addressing those deficiencies prior to the scheduled PDUFA action date of January 31, 2026, once disclosed to the Company."

Canada filing • EMA filing • FDA event • MHRA filing • PDUFA • Allergy

Pharmacokinetics and pharmacodynamics of AQST-109: phase 3 results comparing epinephrine sublingual film with intramuscular injection. (PubMed, Ann Allergy Asthma Immunol) - "SD AQST-109 demonstrated PK exposures consistently bracketed within established levels for approved IM epinephrine and autoinjectors, with a more rapid Tmax and comparable PD responses. These results suggest that AQST-109 represents a safe and effective alternative to injectable epinephrine that is more portable and needle free."

Journal • P3 data • PK/PD data

Sublingual Epinephrine (Anaphylm™™) Provides Consistent Pharmacokinetics in both Adult and Pediatric Subjects (ACAAI 2025) - "Results In adult subjects, median Tmax (and IQR) were as follows: sublingual epinephrine median 12 min (IQR 5.0 min); EpiPen, median 20 min (IQR 25 min); Auvi-Q, median 30 min (IQR 32 min); and manual IM injection, median 50 min (IQR 15 min)...Conclusion In both adult and pediatric subjects, sublingual epinephrine achieved the fastest median Tmax (12 min), with the narrowest IQR (5 min), indicating the tightest clustering of individual responses and thus the lowest interpatient variability compared to autoinjectors or IM injection. Anaphylm’s PK consistency suggests potentially greater clinical dependability than currently available autoinjectors, if approved."

Clinical • PK/PD data • Pediatrics

Phase 1 Evaluation of Anaphylm Sublingual Film: Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability in Pediatric Patients at High Risk for Allergic Reactions (AAP-NCE 2025) - "In pediatric subjects, DESF demonstrated PK and PD profiles comparable to adult data, along with a favorable safety and tolerability profile. These results support DESF as a promising, non-invasive epinephrine delivery option for the treatment of anaphylaxis in children. The findings are a key component of the New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA), and further highlight DESF's potential to expand treatment accessibility across a broad age range."

Clinical • P1 data • PK/PD data • Allergy • Mucositis • Pediatrics • Stomatitis

Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm (GlobeNewswire) - "The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm remains January 31, 2026."

FDA event • PDUFA • Allergy

Aquestive Therapeutics Provides International Expansion Update for Anaphylm (epinephrine) Sublingual Film (GlobeNewswire) - "Aquestive Therapeutics, Inc...announced today that Health Canada has granted the Company a meeting to discuss Aquestive’s planned New Drug Submission (NDS) for Anaphylm (epinephrine) Sublingual Film in Canada. In addition, the Company has submitted an initial briefing book to the European Medicines Agency (EMA). The Company plans to submit a Marketing Authorization Application (MAA) to the EMA as soon as possible."

EMA filing • Regulatory • Immunology

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm for the Treatment of Severe Allergic Reactions (The Manila Times) - "Aquestive Therapeutics, Inc...announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for Anaphylm in the treatment of Type 1 allergic reactions, including anaphylaxis, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 31, 2026. The FDA reiterated that it may decide to conduct an Advisory Committee meeting for the approval of Anaphylm. If approved by the FDA, Anaphylm would be the first and only orally delivered epinephrine option for the treatment of severe allergic reactions in the United States."

FDA filing • PDUFA • Allergy • Immunology

Rapid Symptom Resolution in Oral Allergy Syndrome Following Anaphylm Administration: A Phase 2 Study Update (EAACI 2025) - "Conclusion These findings demonstrate that Anaphylm facilitates rapid symptom resolution following allergen exposure in OAS, with a median resolution time significantly shorter than previously reported literature estimates (~60 minutes). The study reinforces the utility of OAS as a model for evaluating novel epinephrine formulations and their impact on symptom relief kinetics when considering their use in anaphylaxis."

Late-breaking abstract • P2 data • Allergy • Immunology

Aquestive Therapeutics Announces Positive Topline PK Results from its Pediatric Study and Completes the NDA Submission for Anaphylm (epinephrine) Sublingual Film (GlobeNewswire) - P=NA | N=NA | AQ109302 | "Aquestive Therapeutics, Inc...today announced positive topline results from its pediatric study for Anaphylm (epinephrine) sublingual film in patients aged seven to seventeen and weighing greater that thirty kilograms with a personal history of allergic reactions....Aquestive has submitted the Anaphylm NDA to the U.S. Food and Drug Administration (FDA) and expects to receive potential acceptance of the NDA during the second quarter of 2025....These results demonstrate that Anaphylm maintains its consistent PK profile in pediatric patients between the ages of seven and seventeen and weighing greater than thirty kilograms....We continue to prepare for commercial readiness and plan to launch Anaphylm in the first quarter of 2026, if approved by the FDA....Importantly, Anaphylm was shown to be safe and well-tolerated with no serious adverse events (SAEs) reported."

FDA filing • Launch US • Allergy

Aquestive Therapeutics to Present New Findings on Anaphylm (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting (GlobeNewswire) - P2 | N=36 | NCT06527937 | Sponsor: Aquestive Therapeutics | "Aquestive Therapeutics, Inc...today announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting...In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study ('OASIS') study...Anaphylm matched or exceeded IM epinephrine in all key PK parameters. No significant differences in drug performance compared to IM epinephrine were observed, regardless of whether patients had an oral allergen challenge or not. Median symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes."

P2 data • Real-world • Allergy • Immunology

Oral Anaphylm Symptom Intervention Study (OASIS) (AAAAI-WAO 2025) - "Conclusions This study demonstrates that oral physiological changes induced by allergen exposure in subjects with OAS do not alter the pharmacokinetic or pharmacodynamic profiles of Anaphylm. A challenge model of OAS may serve as a potential tool to better understand the value of new epinephrine technologies that cannot be ethically or feasibly studied in anaphylaxis."

Late-breaking abstract • Cardiovascular • Immunology

Stability Results of AnaphylmTM (Epinephrine Sublingual Film) Under Extreme Temperature Conditions (AAAAI-WAO 2025) - "Conclusions This study demonstrated that Anaphylm maintains stability across a wide range of extreme temperatures, proving robust resilience to environmental stressors. These findings validate Anaphylm's reliability in real-world conditions, ensuring sustained efficacy and potency throughout its shelf life for patients facing life-threatening allergic reactions."

Allergy • Immunology

Epinephrine Delivered via Sublingual Film (AnaphylmTM) Elicits Rapid and Consistent Pharmacokinetic and Pharmacodynamic Responses (AAAAI-WAO 2025) - "Results After single dose administration, the T max variability as reflected by interquartile range (IQR) was 5.0 minutes (min) for Anaphylm (median T max 12 min), 23.5 min for EpiPen (median T max 20 min), 32.0 min for Auvi-Q (median T max 30 min), and 15.0 min for manual IM injection (median T max 50 min)...Moreover, Anaphylm's PD profile showed clinically relevant increases in SBP, DBP, and HR. These results further support the development of sublingual epinephrine film as a reliable needle-free alternative for the treatment of Type I allergic reactions, including anaphylaxis."

PK/PD data • Allergy • Immunology

Durability of AnaphylmTM (Epinephrine Sublingual Film) under Real-World Use (AAAAI-WAO 2025) - "Conclusions Anaphylm demonstrated durability, stability and performance within specification after exposure to extreme real-world conditions. Performance attributes demonstrated that Anaphylm is the sole epinephrine rescue candidate proven effective under sub-freezing conditions, when other liquid-based formulations would freeze."

Clinical • Real-world • Real-world evidence • Allergy • Immunology

Integrated Phase I Pharmacokinetics and Pharmacodynamics of Epinephrine Administered via Sublingual Film, Autoinjector, or Manual Injection. (PubMed, Ann Allergy Asthma Immunol) - "AQST-109 delivered epinephrine with PK and PD results within the bracketed range of approved IM products. AQST-109 shows promise as an innovative, needle-free, non-device, portable and orally delivered alternative for the first-line treatment of Type I allergic reactions, including anaphylaxis."

Journal • P1 data • PK/PD data • Allergy

Pharmacokinetics Study of DESF in Adults with Oral Allergy Syndrome (clinicaltrials.gov) - P2 | N=36 | Completed | Sponsor: Aquestive Therapeutics | Recruiting ➔ Completed

Trial completion • Allergy • Immunology

Pharmacokinetics and Pharmacodynamics of Epinephrine Following Administration via Sublingual Film, Autoinjector, or Manual Injection (AAAAI 2024) - "The final formulation of AQST-109 was compared with epinephrine delivered by two different approved autoinjectors (EpiPen and Auvi-Q) or by manual injection (IM)... The PK and PD of AQST-109 delivered epinephrine within range of the approved epinephrine manual IM and EAI products. These results demonstrate that the sublingual administration of the novel prodrug in AQST-109 shows promise as a viable needle-free alternative for treatment of Type I allergic reactions."

PK/PD data • Allergy