WARREN -
Anaphylm is the Company's orally administered epinephrine prodrug product candidate under development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.
The two-part, Phase 3, single-center, open-label, randomized study is designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anaphylm versus single and repeat doses of the epinephrine IM injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy adult subjects. The primary objective is to compare the PK of epinephrine following the single administration of Anaphylm to single administration of epinephrine IM injection in healthy adult subjects. The secondary objectives include evaluating PK sustainability following repeat administration and evaluating the safety and tolerability following single and repeat administrations versus epinephrine IM injection and epinephrine autoinjectors.
'With the dosing of our first patient, we are officially one step closer to reaching our goal of filing our Anaphylm New Drug Application with the FDA in 2024,' said
Part A of the two-part Phase 3 is designed as a three-period, three-treatment, six sequence, comparative PK study and is expected to enroll up to 36 subjects. Part A will assess both the PK performance and sustainability of Anaphylm 12mg with the bracketed comparison of an epinephrine autoinjector (EpiPen) and epinephrine manual IM injection. Part B is designed as a four-period, four-treatment, four-sequence, comparative PK study and is expected to enroll up to 64 subjects, inclusive of those who participated in Part
About Anaphylm
Anaphylm is a polymer matrix-based epinephrine prodrug candidate product. The product is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The tradename for AQST-109 'Anaphylm' has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About
Aquestive is pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the
Forward-Looking Statement
Certain statements in this press release include 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'believe,' 'anticipate,' 'plan,' 'expect,' 'estimate,' 'intend,' 'may,' 'will,' or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the FDA, regarding the potential benefits Anaphylm could bring to patients, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on the Company's business including with respect to its clinical trials including site initiation, enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approval of Anaphylm and Libervant, pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution and ongoing availability of an appropriate labor force and skilled professionals.
These forward-looking statements are based on the Company's current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company's development work, including any delays or changes to the timing, cost and success of its product development activities and clinical trials for Anaphylm and our other product candidates; risk of the Company's ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anaphylm; risk of the Company's ability to address the
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