The Safety of AQUI-S 20E (10% Eugenol) as a Sedative on Clownfish at Cornell University

Principal Investigator: Rodman Getchell

Department of Microbiology and Immunology
Sponsor: FDA-Food & Drug Administration
Grant Number: 1R01FD007317-01
Title: The Safety of AQUI-S 20E (10% Eugenol) as a Sedative on Clownfish at Cornell University
Project Amount: $137,063
Project Period: May 2021 to April 2022

DESCRIPTION (provided by applicant): 

Generation and dissemination of data for safe and effective therapeutic applications for minor use in major species or for use in minor species is a priority of the FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS). This project addresses the need to increase the availability of fish sedatives for marine finfish. The lack of approved drugs for marine finfish producers is threatening the growth and long-term viability of these collective industries and the security of our food supply. Although some new aquaculture drugs have been added to the collective finfish “medicine chest” in the past 10-15 years, the total number of FDA approved drugs for aquatic animals is still very limited. Researchers within the Cornell University Aquatic Animal Health Program and USFWS Aquatic Animal Drug Approval Partnership (AADAP) program are proposing to continue a collaboration to conduct studies to increase the number of safe and effective drugs that can be used to benefit the U.S. aquaculture community. A target animal safety study will be conducted with a eugenol-based sedative (AQUI-S 20E®). Cornell University’s Aquatic Animal Health Program brings a long history of conducting research on fish therapeutants and was funded by USDA NIFA during the last two years. This grant application proposes tasks that will be completed in partnership with the team of researchers, pathologists, statisticians, and quality assurance personnel at both the Cornell University College of Veterinary Medicine and AADAP. This study will evaluate the safety of AQUI-S®20E to saltwater-reared marine finfish when overexposed to either the highest proposed efficacious dose (1×) or 1.5× the highest proposed efficacious dose. The target animal safety study of AQUI-S 20E® will be conducted with clownfish, one of the most popular ornamental species cultured in the U.S. The results of these safety studies, if accepted by FDA/CVM, will be used to complete the TAS technical section data requirements for marine finfish and support a New Animal Drug Application to FDA/CVM to approve the use of AQUI-S 20E® as a sedative for marine finfish.