Aquestive takes big stride towards bringing oral anaphylaxis therapy to market
15 Mar 2024
Clinical ResultPhase 3Phase 2
Aquestive Therapeutics’ Anaphylm (epinephrine) sublingual film moved a step closer to being the first oral therapy approved for severe allergic reactions, including anaphylaxis, after top-line findings from a Phase III study showed rapid and sustained plasma epinephrine levels comparable to currently-approved autoinjectors.
CEO Daniel Barber said the company is “extremely pleased with the pivotal study results” and is aiming to submit a marketing application to the FDA by the end of the year. Barber added that Anaphylm’s performance was “unprecedented among the alternate delivery options under development,” which include Belhaven Biopharma’s nasal dry powder epinephrine device Nasdepi.
On par with autoinjectors
The two-part study assessed single and repeat doses of Anaphylm against epinephrine autoinjectors - Viatris’ EpiPen and Kaleo’s Auvi-Q - as well as an intramuscular epinephrine injection. While the single-dose part focussed on comparison of pharmacokinetics (PK) as the primary endpoint, the repeat-dosing part looked at PK sustainability and safety as secondary goals.
In the single-dose part involving 64 healthy adults, Anaphylm demonstrated a median time to maximum concentration of 12 minutes, quicker than EpiPen’s 20 minutes and Auvi-Q’s 30 minutes. Exposure levels of Anaphylm, evidenced by area under the curve, remained similar to those of autoinjectors during the first 30 minutes after dosing.
In the repeat-dosing part involving 36 participants, plasma epinephrine levels with Anaphylm were comparable to or greater than the injectables at almost all timepoints up to two hours. In both parts, Anaphylm was well tolerated without any serious adverse events.
FDA concerns addressed
Additionally, Aquestive highlighted feedback received from the FDA following a recent Type C meeting at which the company addressed issues - namely product hold time, potential for emesis, and the impact of mouth conditions such as angioedema - that arose after an end-of-Phase II meeting with the agency. For the latter, the drugmaker intends to soon conduct an additional study evaluating Anaphylm’s PK performance after oral exposure to a known allergen.
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