epinephrine (AQST-108) / Aquestive - LARVOL DELTA

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

Recognizing Unmet Needs in Anaphylaxis Care: Insights from Clinician and Caregiver Surveys (ACAAI 2025) - "Additional clinician education is needed for evaluation of emerging epinephrine products. Feedback from providers and caregivers indicates that novel delivery platforms hold promise for improving both portability and time to epinephrine administration."

Clinical • Food Hypersensitivity

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

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

New P2 trial • 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

Comparison of the Pharmacokinetic and Pharmacodynamic profiles of epinephrine delivered by a sublingually absorbed film (DESF), versus 0.3 mg administered by a standard IM injection or the EpiPen® (AAAAI 2023) - "DESF provides a unique and distinctly attractive PK profile relative to 0.3 mg injectable IM epinephrine, with a faster median Tmax and higher early dose partial AUC’s between 15-30 minutes. DESF shows promise as a viable alternative for the treatment of anaphylaxis."

Late-breaking abstract • PK/PD data

Pharmacokinetics of epinephrine sublingual film following three different administration procedures (AAAAI 2023) - "Rationale:AQST-109 is the first and only sublingual film using a novel prodrug of epinephrine (DESF) being developed for the same target indication as epinephrine injection in the emergency treatment of Type 1 allergic reactions...All administration routes produced rapid clinically relevant epinephrine Tmax, Cmax and early exposure levels which outperformed the IM injection route. Holding saliva during administration enhanced early exposure. Not holding saliva still provides clinically meaningful levels but increase the risk of lower absorption relative to the other procedures."

PK/PD data • Allergy

Impact of food exposure on the pharmacokinetics of epinephrine sublingual film (AAAAI 2023) - "Rationale:AQST-109 is the first and only sublingual film using a novel prodrug of epinephrine (DESF) being developed for the same target indication as epinephrine injection in the emergency treatment of Type 1 allergic reactions...These results suggest that the presence of food residue from a sticky substance such as peanut butter, has no relevant impact on the pharmacokinetics or pharmacodynamics of DESF. Tmax, Cmax, early partial AUCs, and pharmacodynamic responses were consistent regardless of the presence of food residue. This provides reassurance that the product absorption would not be impaired in “real-world” situations if used to treat a food allergy with very recent ingestion."

PK/PD data • Allergy • Food Hypersensitivity • Immunology

Pharmacokinetics and pharmacodynamics of epinephrine sublingual film versus intra-muscular epinephrine (AAAAI 2023) - "AQST-109 is the first and only sublingual film using a novel prodrug of epinephrine (DESF) being developed for the same target indication as epinephrine injection in the emergency treatment of Type 1 allergic reactions...These results suggest that sublingual DESF provides comparable levels of epinephrine to that of IM epinephrine and achieved an epinephrine plasma Tmax in a significantly shorter time frame. Preliminary work suggests that sublingual DESF is a safe, alternative treatment that would address major unmet needs in patients at risk of anaphylaxis."

PK/PD data • Allergy

"$AQST Aquestive Therapeutics Receives Positive FDA Written Response for AQST-109 Epinephrine Sublingual Film https://t.co/i1BLBBRolO" (@stock_titan)

Aquestive Therapeutics Files IND for Pharmacokinetic Clinical Trials of AQST-108 (Sublingual Film Formulation Delivering Systemic Epinephrine) for Anaphylaxis Treatment (GlobeNewswire) - "Aquestive Therapeutics, Inc....announced today that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for pharmacokinetic (PK) clinical trials of its drug candidate AQST-108."

IND • Allergy • Immunology

Aquestive Therapeutics reports first quarter 2020 financial results and provides business update: AQST-108 and libervant remain on track (GlobeNewswire, Aquestive Therapeutics, Inc.) - "Expects to submit AQST-108 (epinephrine) IND by June 2020 and to commence PK trials by end of 2020....The Food and Drug Administration (FDA) confirmed that the drug candidate will be reviewed under the 505(b)(2) regulatory approval pathway, and that no additional studies will be necessary prior to opening the proposed IND application...Expected to meet adjusted EBITDA targets by reducing expenses by limiting...to...AQST-108."

Commercial • IND • New trial • CNS Disorders • Epilepsy • Infectious Disease • Novel Coronavirus Disease