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The US Food and Drug Administration approved the first nasal spray epinephrine drug for severe ... barriers to rapid treatment of anaphylaxis.” The approval was based on studies in 175 healthy ...
[2] [30] [38] It is the first nasal spray for the treatment of anaphylaxis approved by the US Food and Drug Administration (FDA). [30] The approval of epinephrine nasal spray is based on four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of epinephrine ...
The US Food and Drug Administration on Tuesday did not approve a needle-free epinephrine for treatment of severe allergic reactions, a move that drugmaker ARS Pharmaceuticals called surprising.
The nasal-spray Neffy was rejected by the FDA. The epinephrine nasal spray would've been the first needle-free alternative to EpiPens, but the FDA said additional research was needed.
Anaphylm has the potential to be the first and only orally delivered epinephrine product for the treatment of severe allergic reactions, including anaphylaxis, if approved by the FDA. “We believe FDA alignment on the completeness of our adult development program for Anaphylm is a major milestone for the Company and the allergy community ...
An epinephrine autoinjector (or adrenaline autoinjector, also known by the trademark EpiPen) is a medical device for injecting a measured dose or doses of epinephrine (adrenaline) by means of autoinjector technology. It is most often used for the treatment of anaphylaxis. The first epinephrine autoinjector was brought to market in 1983.
WARREN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today commented on the approval of a non-injection-based device for delivery of epinephrine for the treatment of ...
Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026. AQST-108 (epinephrine) Topical Gel The Company completed its first human clinical study for AQST-108. The two-part study ...
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