Pharmacokinetics and pharmacodynamics of AQST-109 sublingual film in oral allergy syndrome: A phase 2 study.
Anna Nowak-Wegrzyn, David M Fleischer, Jay A Lieberman et al.
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In 30 seconds
This phase 2, open-label, randomized, fixed-sequence crossover study compared the pharmacokinetics and pharmacodynamics of sublingual AQST-109 in adults with screening-confirmed oral allergy syndrome, with and without oral allergen challenge (OAC). The challenge elicited moderate or severe oral symptoms in 94.4% of 36 patients. AQST-109 pharmacokinetic values were similar with and without OAC, and pharmacodynamic measures were not diminished by challenge after single or repeat dosing. The study also compared AQST-109 with intramuscular epinephrine given without OAC; pharmacodynamic parameters were higher with AQST-109 after OAC.
Key findings
- OAC elicited moderate or severe oral symptoms in 94.4% of the 36 patients.
- AQST-109 pharmacokinetic values were similar with and without OAC.
- Pharmacodynamic measures were not impacted by OAC after single or repeat AQST-109 dosing.
- Almost all patients had a related mild treatment-emergent adverse event; four events were moderate, with no new safety signals identified.
Why it matters
Oral symptoms during allergic reactions could plausibly affect absorption of a sublingual treatment. In this study, challenge-induced symptoms did not diminish AQST-109 pharmacokinetic or pharmacodynamic measures, providing evidence relevant to its performance in this context. The findings are preliminary and concern an investigational product, so they do not establish effectiveness during anaphylaxis.
What to keep in mind
The study was open-label and assessed single and repeat doses in adults with oral allergy syndrome undergoing allergen challenge; it does not establish effectiveness during anaphylaxis.