Aquaculture Drugs

1
Aquaculture DrugsUpdate

• Rosalie (Roz) Schnick
• Michigan State University
• RozSchnick_at_Centurytel.net
• http//ag.ansc.purdue.edu/aquanic/jsa/aquadrugs/in
  dex.htm
• Presented at the National Association of State
  Aquaculture Coordinators, Louisville, Kentucky,
  June 2-5, 2004

2
Major Initiative Nearing Final Completion

• Federal-State Aquaculture Drug Approval
  Partnership Project (IAFWA Project)
• Main partners
• Aquatic Animal Drug Approval Partnership Program
  (AADAP)
• Upper Midwest Environmental Sciences Center
  (UMESC)
• Harry K. Dupree Stuttgart National Aquaculture
  Research Center (SNARC)
• Eight years, formal portion ended September 2002
• 12 million
• 9 drugs (marked in turquoise)

3
IAFWA Project Submissions Acceptances (9/03
3/04)
Drug/Initial Label Claims Submissions Acceptances
AQUI-S/1 5 4
Copper sulfate/1 0 0
Chloramine-T/2 0 2
Florfenicol/4 4 1
Formalin/3 (2 approved) 1 0
Hydrogen peroxide/4 1 5
Oxytetracycline (oral)/2 0 2
Oxytetracycline (immersion)/4 (1 approved) 1 1
Potassium permanganate/1 0 0
TOTALS9 Drugs/22 label claims 12 15
4
IAFWA Project Submissions Acceptances (9/03
3/04)
Submitter Submissions Acceptances
AADAP 2 (EFF studies) 5 (4 EFF studies, 1 FOI)
Sponsors 7 (2 PC, 4 ES, 1 HFS) 3 (1 PC, 1 TAS, 1 NADA approved)
UMESC 3 (2 EFF, 1 EFF dose) 7 (3 TAS, 4 EFF Technical sections)
TOTAL 12 15
5
STATUS OF EFFORTS TOWARD APPROVALSAQUACULTURE
THERAPEUTANTS
6
Completed or Nearing CompletionOral
Antibacterials

• Erythromycin (BPA, NRSP-7, University of Idaho)
• Bacterial kidney diseasesalmon
• Florfenicol (was IAFWA Project, MCGP, sponsor)
• Furunculosis columnaris diseasefreshwater-reared
  salmonids (AADAP, UMESC)
• Coldwater diseasefreshwater-reared salmonids
  (AADAP, UMESC)
• Enteric septicemiacatfish (UMESC)
• Systemic columnaris diseasefreshwater-reared
  salmonids catfish (AADAP UMESC)

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Completed or Nearing CompletionOral
Antibacterials (continued)

• Oxytetracycline (oral)approvalsvarious
  diseasescatfish, salmonids, lobsters
• Coldwater diseaseall freshwater-reared salmonids
  (AADAP, UMESC)
• Systemic columnaris diseasesteelhead trout
  (AADAP, UMESC)
• Romet-30approvalsvarious diseasescatfish
  salmonids
• Romet-TCimproved palatability for top
  coatingaccepted November 2003
• Sulfamerazineapproved for furunculosissalmonids
  (sponsor not currently distributing product)

8
Work UnderwayOral Antibacterials (continued)

• Amoxicillin (sponsor, Kent SeaTech, NRSP-7,
  SNARC)
• Streptococcushybrid striped bass tilapia (work
  underway)
• Oxytetracycline (oral)approvals for catfish,
  salmonids, and lobsters
• Systemic bacterial diseasesflounder and tilapia
  (NRSP-7)
• Streptococcustilapia (SNARC)

9
Nearing CompletionExternal antibacterials

• Chloramine-T (IAFWA Project and sponsor)
• Bacterial gill diseaseall freshwater-reared
  salmonids (AADAP, UMESC)
• External columnaris diseasewalleye (UMESC)

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Nearing CompletionExternal antibacterials
(continued)

• Hydrogen peroxide (IAFWA Project)
• Bacterial gill diseaseall freshwater-reared
  salmonids (UMESC)
• External columnaris diseaseall coolwater fish
  channel catfish (UMESC)
• Oxytetracycline immersion (IAFWA Project MCGP)
• Bacterial gill diseasecoolwater warmwater fish
  (UMESC)
• External columnaris diseasecoolwater warmwater
  fish (UMESC)
• Systemic columnaris diseasecoolwater warmwater
  fish (UMESC)

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Work Underway or PossibilityExternal
antibacterials (continued)

• Copper sulfate (IAFWA Project)
• Possibility for development (SNARC)
• Potassium permanganate (IAFWA Project)
• Possibility for development (SNARC)
• Pyceze (sponsor)
• Early development stage

12
Completed or Nearing CompletionFungicides
(control saprolegniasis)

• Formalinsalmon, trout, esocid eggs
• Approval extended (IAFWA Project, UMESC)all fish
  eggs 6/18/98
• Almost completeall fish (UMESC)
• Hydrogen peroxide (IAFWA Project)
• Almost completeall fish eggs (UMESC)
• Almost completeall fish (UMESC)

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Work UnderwayFungicides (control saprolegniasis)
(continued)

• Copper sulfate (IAFWA Project sponsor)
• Work underway (SNARC)
• Potassium permanganate (IAFWA Project)
• Possibility for development (SNARC)
• Pyceze (sponsor)
• Work underway

14
Completed or Nearing CompletionExternal
parasiticides

• Copper sulfate (IAFWA Project and sponsor)
• Ichthyophthiriuschannel catfish in earthen
  ponds (SNARC)
• FormalinApprovals for certain fish penaeid
  shrimpexternal protozoans
• Approval extended (NRSP-7, IAFWA Project,
  UMESC)all fishexternal protozoans monogenetic
  trematodes 6/18/98
• Hydrogen peroxide (IAFWA Project)
• External protozoanssalmonids (UMESC)
• Sea lice controls
• SliceSponsor actively pursuing claim

15
Work UnderwayExternal parasiticides (continued)

• Potassium permanganate (IAFWA Project)
• Ichthyophthiriuschannel catfish in earthen
  ponds (SNARC)
• Pyceze (sponsor)
• Early development stage

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Work UnderwayInternal Parasiticides

• Myxozoan controls
• Fumagillin
• Whirling diseasetrout (way underway by FWS,
  others)
• Proliferative gill diseasecatfish (some work by
  Mississippi State University)
• Digenetic trematode or cestode controls
• Praziquantel
• Bolbophorus confusus in catfish (under
  consideration by sponsor)

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STATUS OF EFFORTS TOWARD APPROVALSOTHER
AQUACULTURE DRUGS
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Completed or Work UnderwayZero withdrawal
Anesthetics

• AQUI-S (IAFWA Project and sponsor)major effort
  underway by both entities
• All freshwater-reared fish (AADAP UMESC)
• Saltwater salmonids (sponsor IAFWA Project)
• MS-222
• Approvedseveral fish species but with 21-day
  withdrawal time

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Who Needs Zero Withdrawal Anesthetic?

• All private fish shellfish aquaculture
  industries
• All federal state agencies involved in
• Fish shellfish culture
• Commercial recreational fisheries
• Fisheries stock restoration
• Threatened endangered aquatic species

20
Completed or Work UnderwaySpawning aids

• Human chorionic gonadotropin (many partners)
• Approvedall fish 9/7/99
• Crude carp pituitary (NRSP-7)
• Almost complete but no possibility of product
  chemistry, so LRP?
• Ovaplant Ovaprim (sponsor)
• Work underway
• ReproBoost (sponsor)
• Work underway

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Nearing CompletionGender Manipulation Aids

• 17 alpha-methyltestosterone (sponsor Auburn
  University)tilapia other species
• Contract let for product chemistry data
• Contract let for environmental safety data
• Contract to be let for target animal
  safetytilapia

22
Completed or Work UnderwayChemical Marking Aids

• Calcein (have sponsor)work underway
• Oxytetracycline immersion (NRSP-7, various
  partners including IAFWA Project)
• Approvedall fish 12/24/03
• Strontium chloride (have sponsor)work underway
  through NRSP-7

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FUTURE PLANS
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Future Plans

• Develop data on all drugs in progress for initial
  or supplemental NADAs complete goals of the
  IAFWA Project
• Seek additional sponsors for additional drugs to
  gain initial or supplemental NADAs
• Seek additional funding sources for aquaculture
  drug approval research