Anaphylm (epinephrine) / Aquestive - LARVOL DELTA

Rapid Symptom Resolution in Oral Allergy Syndrome Following Anaphylm Administration: A Phase 2 Study Update (EAACI 2025) - No abstract available

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

Aquestive Therapeutics to Present Positive Data from Pharmacokinetic and Pharmacodynamic Studies for AQST-109 Epinephrine Sublingual Film at American Academy of Allergy, Asthma, and Immunology (AAAAI) Annual Meeting (GlobeNewswire) - "Aquestive Therapeutics...announced that four late breaking posters recapping the positive data from pharmacokinetic and pharmacodynamic studies of AQST-109 epinephrine sublingual film will be presented at the American Academy of Allergy, Asthma, and Immunology (AAAAI) annual meeting, which will be held from February 24-27 in San Antonio, Texas. 'We are excited to share the positive results from our two completed AQST-109 pharmacokinetic and pharmacodynamic studies at the upcoming AAAAI Conference....We look forward to engaging with leaders in the allergy community and providing insights into how our therapeutic candidate has the potential to provide an important advancement for the treatment of acute allergic reactions, if approved by the FDA.'"

Late-breaking abstract • PK/PD data • Allergy • Immunology

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)