Feb. 06, 2020: Aquestive Therapeutics, Inc, announced today that it had a constructive face-to-face pre-IND Application meeting with the U.S.FDA for its drug candidate, AQST-108, a “first of its kind”
Oral sublingual film formulation delivering systemic epinephrine under development for anaphylaxis treatment using Aquestive’s proprietary PharmFilm ® technology.A pre-IND meeting provides an opportunity for an open communication between a drug sponsor and the FDA in order to discuss the sponsor’s IND development plan and to obtain the agency’s guidance for the clinical studies for the sponsor’s new drug candidate.
The FDA has confirmed that the clinical development for AQST108 will be reviewed under the 505(b(2) pathway as proposed by Aquestive and that no further studies would be required before the proposed IND application is opened.
The FDA indicated that patients who resist the standard use of intramuscular injection in the treatment of anaphylaxis appear to have an unmet medical need, and that AQST-108 may potentially address some of those unmet needs.
“Anaphylaxis is a severe condition affecting a large population of patients for whom a major unmet need exists. The only options available to patients currently require an injection and AQST-108 would potentially bring major progress and positive change to patients.”
AQST-108: AQST-108 is a “first of its kind” oral sublingual film formulation for delivering systemic epinephrine that is in development for the treatment of anaphylaxis using Aquestive’s proprietary PharmFilm® technologies.
https://fda.einnews.com/pr_news/509054323/aquestive-therapeutics-announces-fda-confirmed-505-b-2-pathway-for-aqst-108-sublingual-film-formulation-delivering-systemic-epinephrine-for
