A Pharmacokinetic Study of a Botanical Extract
DESCRIPTION (provided by applicant): A new approach is proposed for conducting
pharmacokinetic studies of a pharmacologically active botanical extract
containing mixtures of several classes of active and inactive compounds. We are
currently developing the botanical extract as a botanical drug under an allowed
Investigational New Drug (IND) by the FDA. We have identified key marker
compounds for PK studies based on relevant biological activity and relative
abundance in the extract. We propose to develop and validate a sensitive and
accurate analytical method for quantitation of the marker compounds from plasma
matrix in Phase I. Development of these methods will ultimately generate a
robust approach for conducting routine GLP PK studies in animals and humans,
which will be the subject of Phase II. The PK studies in human will provide new
information, which will be used for NDA approval of the botanical drug as an
effective treatment of insomnia, a condition with a large unmet medical need
for effective and safe therapeutics with a low adverse effect profile.
Successful completion of the long-range goals also will enable development of
unique formulations and selection of dose regimen in elderly populations.
PROPOSED COMMERCIAL APPLICATION:
This project will support the development, under IND, of an important new class of drugs,
the Botanical Drug Product. The botanical extract, which is the subject of this study, will be developed as an effective and safe new therapeutic for insomnia, a condition where currently 95% of those affected by the disease are not currently taking prescription medication. The
botanical extract we will develop as a new drug has a favorable profile relative to the "ideal"
drug for treatment of this condition.
Small Business Information at Submission:
Principal Investigator:Ronald Goldblum
ANCILE PHARMACEUTICALS, INC.
10555 SCIENCE CENTER DR, STE B SAN DIEGO, CA 92121
Number of Employees: