Epinephrine

A novel epinephrine film, Anaphylm, developed by Aquestive Therapeutics, provides rapid relief for oral allergy syndrome (OAS) symptoms, with complete symptom relief in about 12 minutes. The film's effectiveness was tested in OAS patients to ensure mouth swelling does not hinder absorption. Aquestive plans to conduct further studies and submit Anaphylm for FDA approval in early 2025, aiming for a 2026 launch. The film, designed for adults and children weighing 66 pounds and more, offers a convenient alternative to auto-injectors.

Aquestive Therapeutics announces positive OAS challenge study results for Anaphylm, showing rapid symptom resolution and consistent PK profile. The study met primary and secondary endpoints, positioning Anaphylm for a pre-NDA meeting in Q4 2024.

Anaphylm (epinephrine) sublingual film rapidly resolves severe allergic reaction symptoms within 2 minutes, with a consistent pharmacokinetic profile. The Oral Allergy Syndrome (OAS) challenge study demonstrated Anaphylm's efficacy and safety, prompting Aquestive Therapeutics to seek FDA pre-NDA meeting and plan pediatric trials and NDA submission.

Prescription drugs like Sovaldi, Humira, Epipen, Insulin, Cymbalta, and Ozempic/Wegovy cost significantly more in the U.S. than in other countries. Reasons for this disparity include lack of government price regulation, market exclusivity, high R&D costs, complex pricing structures, consumer willingness to pay, lobbying influence, global pricing strategies, and limited competition. The U.S. has not regulated prices due to its free-market system's success in producing breakthrough drugs and the pharmaceutical industry's economic importance. Government intervention, such as Medicare negotiating drug prices and capping costs, is becoming more common to address high drug prices.

EURneffy, a needle-free adrenaline nasal spray, was approved in the EU and US as a first-of-its-kind treatment for anaphylaxis, overcoming barriers like fear of injections and accidental needle-related side effects. It offers comparable efficacy to traditional injectables, with simpler use and better temperature sensitivity, potentially increasing patient compliance.

Epinephrine nasal spray Neffy, developed by ARS Pharmaceuticals, aims to reduce fear of needle injections for treating severe allergic reactions. FDA-approved for patients 66 lbs or heavier, it offers painless, instantaneous relief with potential side effects like throat irritation. ARS is working on lower doses for children and infants.

ARS Pharmaceuticals introduces Neffy, a needle-free epinephrine nasal spray for treating severe allergic reactions, approved by the FDA. Aimed at reducing fear and hesitation associated with EpiPen injections, Neffy offers a simpler, quicker administration method, potentially improving treatment accessibility for millions.