Aquestive Therapeutics

December 2024 FDA updates: Approved treatments include ustekinumab-kfce for inflammatory diseases, crinecerfont for CAH, nemolizumab for AD, and olezarsen for FCS. Notable actions: RMAT designation for rexlemestrocel-L, Boxed Warning for fezolinetant, and CRLs for glepaglutide and sotagliflozin. Pipeline updates: Tirzepatide outperformed semaglutide in weight loss, and novel therapies for HCV, PNH, and EoE showed promise.

FDA approved first generic GLP-1 injection for type 2 diabetes in patients 10+. Needle-free options for pediatric anaphylaxis and influenza emerged. Top 5 pediatric care videos of 2024 highlighted. AAP tips for managing kids' tech gifts. Speculation on Tiny Tim's diagnosis in 'A Christmas Carol'.

2024 marked significant advancements in allergy medicine, including FDA approvals for treatments like omalizumab (Xolair) for food allergies, fluticasone propionate nasal spray (XHANCE) for chronic rhinosinusitis, and epinephrine nasal spray (neffy) for anaphylaxis. New data on allergens in infant skincare and guidelines for allergen immunotherapy documentation were also highlighted.

2024 saw FDA approvals for needle-free pediatric treatments: epinephrine nasal spray (neffy) for anaphylaxis and FluMist for influenza, addressing needle phobia and improving vaccine administration.

Aquestive Therapeutics (NASDAQ:AQST) secured FDA Orphan Drug Exclusivity for Libervant Buccal Film, extending market exclusivity to April 2031 for treating seizure clusters in children aged two to five.

Aquestive Therapeutics received 7 years of FDA orphan drug exclusivity for Libervant, a buccal diazepam for pediatric seizure clusters, enhancing treatment simplicity over rectal methods. Approved in April 2024, it offers a non-invasive option until April 2031, marking progress in managing seizures in children aged 2-5.

Aquestive Therapeutics, leveraging its PharmFilm technology, is innovating drug delivery with Anaphylm, a sublingual epinephrine film for anaphylaxis treatment. With strong financials and a promising regulatory pathway, Anaphylm could disrupt the epinephrine market, facing competition but also significant growth potential.

Aquestive Therapeutics received positive FDA feedback on its planned NDA submission for Anaphylm (epinephrine) sublingual film, set for early 2025. The FDA agreed with the NDA content and format, endorsed the safety evaluation, and supported the ongoing pediatric trial. No additional adult trials are required, though an advisory committee meeting may precede final decision. Anaphylm could be the first oral epinephrine product for severe allergic reactions, with a projected launch in late 2025 or early 2026.

Aquestive Therapeutics received positive FDA feedback on its planned NDA submission for Anaphylm™ (epinephrine) Sublingual Film, which could be the first orally delivered epinephrine product for treating severe allergic reactions. The company plans to submit the NDA in Q1 2025 after completing a pediatric trial.

Aquestive Therapeutics received positive FDA feedback on Anaphylm™ (epinephrine) Sublingual Film, confirming no additional adult clinical trials are necessary prior to NDA submission in Q1 2025. A pediatric trial has commenced in the U.S. and Canada.