Tricaine (MS-222) is the only drug currently approved by the US Food and Drug Administ ration (FDA) for fish sedation. Cornell University researchers have teamed up with the USFWS Aquatic Animal Drug Approval Partnership (AADAP) to generate data to support approval of a new fish sedative by FDA’s Center for Veterinary Medicine (CVM). Our overall goal is to increase the number of safe and effective drugs that can be used by the aquaculture industry. We have conducted a series of studies under a FDA concurred protocol (AQS20E-18-SEA-TAS.2b) to evaluate the safety of AQUI-S®20E (10% eugenol) to sedate marine fish to the handleable stage of anesthesia in saltwater . This project has generated margin of safety data to support a New Animal Drug Application to the FDA to approve the use of AQUI-S®20E for this indication in marine finfish. FDA-CVM depends on stakeholders such as fish health researchers, drug sponsors, AADAP, and the Drug Approval Working Group (DAWG) to increase the number of safe and effective drugs that can be used by the public and private aquaculture groups. The DAWG is comprised of members from state resource agencies, as well as from USFWS, NOAA, and USGS. Since the late 1990s, AADAP has contributed to virtually every new fish medication approved by the FDA. Cornell University’s Aquatic Animal Health Program also brings a long history of conducting research on fish therapeutants.
With support from USDA -NIFA and the FDA MUMS grants we have continued our efforts to generate data for safe and effective therapeutic applications of animal drugs for minor species (such as fish). The ultimate outcome of these studies will be the FDA approval of a fish anesthetic that requires no withdrawal period, i.e., an immediate-release anesthetic. We have completed our three consecutive target animal safety studies with AQUI-S® 20E and determined there was an adequate margin of safety when juvenile Striped Bass Morone saxatilis , Florida Pompano Trachinotus carolinus, and Y ellow Clownfish Amphiprion clarkii were sedated with a dose of 400 mg/L or 600 mg/L AQUI-S® 20E . The statistical results from survival, fish health, and behavior qualitative comparisons will be presented.