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A Bioequivalence Study of Two Different Formulations of Chlorambucil in Beagle Dogs

Award Number: R01FD007590
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 05/31/2023

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A Bioequivalence Study of Two Different Formulations of Chlorambucil in Beagle Dogs - Chronic Lymphocytic Leukemia (CLL) in dogs represents an unmet veterinary need. The literature reports a response rate of 70% to protocols using vincristine, prednisone, and chlorambucil combinations; with chlorambucil as the maintenance drug. However, despite therapy for CLL being generally rewarding, the mainstay treatment, chlorambucil, is not an FDA approved drug for veterinary use. Presently, chlorambucil licensed for human use is being used off-label, however currently available tablet sizes, 2 mg, of chlorambucil present a challenge for treating dogs at standard prescribed dosages. Due to this challenge, unregulated compounded chlorambucil products, with reports of varying potency and stability, are in wide use in veterinary care with increased risk to the animal population, as well as the owners, pharmacists, and the veterinarians handling these compounded products. As a result, there is a clinical need for a veterinary specific chlorambucil product, developed and manufactured to the highest quality and safety standards, and at the appropriate strength to facilitate accurate dosing in small animals. Chlorambucil 1 mg tablets are being developed to address the limitations of the 2 mg tablets licensed for human use. This product is a Minor Use and Minor Species (MUMS) designated investigational product that is eligible for conditional approval. The proposed study will contribute to completing the requirements of the safety technical section for the designated intended use in dogs with CLL. The safety of chlorambucil 1 mg tablets for the treatment of CLL has been previously established in a target animal safety study using the reference product. This bioavailability study is designed to evaluate the in vivo comparability of two formulations, termed test and reference, of chlorambucil 1 mg tablets in healthy dogs thereby enabling bridging of the previously established safety information of the reference product to the test product. This study will be a randomised, non-terminal GLP (Good Laboratory Practices) study in purpose-bred beagle dogs. The primary outcome variables will be AUC(0-t) and Cmax.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$102 )
2023	2022	EIRGEN PHARMA LIMITED	WESTSIDE BUSINESS PARK	WATERFORD				IRL	Food and Drug Administration Research	000	1	5/12/2023	NEW	-$102
2023	2022	EIRGEN PHARMA LIMITED	WESTSIDE BUSINESS PARK	WATERFORD				IRL	Food and Drug Administration Research	001	1	8/14/2023	NEW	$0
														Subtotal = -$102

Issue Date FY: 2022 ( Subtotal = $250,000 )
2022	2022	EIRGEN PHARMA LIMITED	WESTSIDE BUSINESS PARK	WATERFORD	MUNSTER			IRL	Food and Drug Administration Research	000	1	6/3/2022	NEW	$250,000
														Subtotal = $250,000

Grand Total All Awards = $249,898

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A Bioequivalence Study of Two Different Formulations of Chlorambucil in Beagle Dogs

Award Number: R01FD007590

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 05/31/2023

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