Exploration of developmental approaches to companion animal antimicrobials: providing for the unmet therapeutic needs of dogs and cats.
The American Academy of Veterinary Pharmacology and Therapeutics (AAVPT) and the United States Pharmacopeia (USP) co-sponsored a workshop to explore approaches for developing companion animal antimicrobials. This workshop was developed in response to the shortage of antimicrobials labeled for dogs and cats, as there is a shortage of approved antimicrobials for the range of infectious diseases commonly treated in small animal practice. The objective of the workshop was to identify alternative approaches to data development to support new indications consistent with the unmet therapeutic needs of dogs and cats. The indications for currently approved antimicrobials do not reflect the broader range of infectious diseases that are commonly diagnosed and treated by the veterinarian. Therefore, the labels for these approved antimicrobials provide limited information to the veterinarian for appropriate therapeutic decision-making beyond the few indications listed. Industry, veterinary practice, and regulatory challenges to the development of new antimicrobial indications were discussed. The workshop resulted in short- and long-term recommendations. Short-term recommendations focus on the use of additional data considerations for product labeling. Long-term recommendations center on legislative or regulatory legal initiatives. The workshop recommendations will need collaboration from industry, academia, and regulatory authorities and a legal shift in the drug approval and availability processes.
Kansas State University, USA.
Apley
M
M
Claxton
R
R
Davis
C
C
DeVeau
I
I
Donecker
J
J
Lucas
A
A
Neal
A
A
Papich
M
M
D000818:Animals; D000829:Animals, Domestic; D000890:Anti-Infective Agents / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*; D002371:Cat Diseases / Q000188:drug therapy*; D002415:Cats; D003141:Communicable Diseases / Q000188:drug therapy / Q000662:veterinary*; D004283:Dog Diseases / Q000188:drug therapy*; D004285:Dogs; D017277:Drug Approval / Q000331:legislation & jurisprudence; D007880:Legislation, Drug; D012107:Research Design; D014481:United States; D019155:Veterinary Drugs / Q000493:pharmacokinetics / Q000494:pharmacology / Q000627:therapeutic use*
D000890:Anti-Infective Agents; D019155:Veterinary Drugs