Topline PK Data Released on Self-Administered Epinephrine Sublingual Film for Severe Allergy
PK data from a self-administration study are comparable to those seen following administration by a clinician and Tmax equal at 15 minutes.
Topline pharmacokinetic (PK) data from a self-administration study of epinephrine delivered via sublingual film (Anaphylm) demonstrate that serum concentrations of the drug are comparable to those observed following administration by a health care professional (HCP), according to the manufacturer Aquestive Therapeutics, Inc.
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The orally delivered epinephrine is for the treatment of severe, life-threatening allergic reactions, including anaphylaxis. The company plans to submit a new drug application (NDA) to the US FDA in late 2024 or early 2025, according to a news release.
The new data come from a single dose, 3-period randomized cross over study of 36 healthy adult subjects that compared PK and pharmacodynamics (PD) of the sublingual epinephrine when self-administered, when administered by a health care professional and against PK and PD after intramuscular injection of adrenaline by a health care professional. The PK parameters of primary interest were maximum epinephrine measured in plasma (Cmax) and area under the curve (AUC) at several times following dosing. The study researchers reported no statistical difference in Cmax across the first 60 minutes post-administration between self- and HCP-administered epinephrine sublingual film.
While the median time to maximum concentration (Tmax) for IM adrenaline administered by a clinician was 50 minutes, Tmax for both self- and HCP-administered medication was just 15 minutes.
The PK and PD data show “that rapid and substantial epinephrine absorption is achieved under a variety of administration conditions,” Daniel Barber, president, and CEO of Aquestive said in the news release. “This built-in functionality addresses potential real-world emergency scenarios, where ideal administration may not happen.”
“Experiencing and managing a severe allergic reaction can be unsettling and chaotic for patients and caregivers. An orally administered product that can be rapidly and easily administered has the potential to be a game-changer for the allergy community,” Matthew Greenhawt, MD, MBA, MSc, an anaphylaxis expert, and allergist at Children’s Hospital Colorado and a member of the Aquestive scientific advisory board, said in the release. Greenhawt lauded several features of the sublingual film formulation that are important to both individuals and their caregivers including ease of administration, rapid delivery of epinephrine, no needles, and portability.
Features, benefits
Anaphylm, a trade name conditionally approved by the FDA is “a polymer matrix-based epinephrine prodrug candidate product.” The delivery vehicle is approximately the size of a US postage stamp and comes in packaging that is both thinner and smaller than a credit card. The product is highly portable, weighing less than 1 ounce and amenable to carrying in a pocket. The packaging is resistant to weather excursions including exposure to rain or direct sunlight, according to Aquestive.
Aquestive says the final study that will support the company’s NDA submission to the FDA, the oral allergy syndrome challenge is underway with completion slated for the third or fourth quarter this year. There is also a pediatric study planned, of children weighing 30 kg and more. The company projects a full product launch of epinephrine sublingual film in late 2025 or early 2026.
Anaphylaxis is a potentially fatal systemic hypersensitivity reaction that is a chronic condition for up to 49 million people within the US. Hospital admissions for anaphylaxis have increased between 500% and 700% in the past 10-15 years, according to the news release. Of individuals who had experienced anaphylaxis in the past, more than half (52%) had never been prescribed an epinephrine autoinjector, and of those who had, 60% of them did not have one available to use in the situation that brought them to the hospital.
Epinephrine injection is the current standard of treatment to reverse the severe manifestations of anaphylaxis. The costs associated with the reaction are substantial with annual expenditures estimated at $1.2 billion, direct costs for epinephrine reaching $294 million and indirect costs of $609 million.
