Aquestive Therapeutics has made a strategic funding agreement worth $75m with RTW Investments to support the potential launch of Anaphylm (epinephrine) sublingual film, a matrix-based epinephrine prodrug product candidate.

The funding will be accessible following US Food and Drug Administration (FDA) approval of Anaphylm and the fulfilment of specific refinancing and customary conditions related to the existing debt of the company.

RTW will obtain a tiered single-digit percentage of annual net sales of the product in the US to treat type I allergic reactions, including anaphylaxis, subject to a cap.

RTW Investments managing partner and chief investment officer Roderick Wong stated: “We are excited to support Aquestive, and today’s investment reflects our belief in the commercial prospects of Anaphylm as a rescue treatment for patients experiencing a severe allergic reaction, including anaphylaxis.”

Anaphylm begins to dissolve upon contact, eliminating the need for water or swallowing during administration.

Its packaging is thinner and smaller compared to a standard credit card, allowing for easy portability, and is engineered to withstand weather conditions such as rain and sunlight.

The product trade name for AQST-109 has received conditional approval from the FDA, with final approval dependent on its FDA endorsement.

Aquestive CEO Dan Barber stated: “This financing provides critical capital that will support Aquestive Therapeutics through 2027, enabling us to successfully bring Anaphylm to market, if approved by the FDA, and deliver a new treatment option for patients in need.

“We continue to believe Anaphylm, potentially the first and only oral rescue medication for the treatment of severe allergic reactions, including anaphylaxis, can transform how patients carry and access their rescue medication.”