Development of Alkontrol herbal for Treating Alcohol Abuse

This application for a Fast Track STTR award represents a collaboration between Natural Pharmacia
InternationalIncNPIand McLean Hospital to initiate steps toward commercializing a isoflavone botanical
product for treating alcoholismExcessive use of alcohol accounts for much of the public health burden related
to alcohol use disordersincluding fetal alcohol syndromefatal motor crashesaccidents and homicidesOn
college campuses alonealcohol use results annually in almostdeathssexual assaultsinjuriesandassaultsFor mostproblematic drinking and its associated morbidity will not be
brought to the attention of Primary Care Professionals and so many go without treatmentThis is precisely
where an OTC herbal product could have the greatest impactAn extract of kudzuPueraria lobatahas been
patented by McLean Hospital and licensed it to NPI under the name Alkontrol herbalOver the pastyearsour team has extensively studied this kudzu extract and demonstrated its safety and efficacy in healthy control
subjects as well as in heavy binge drinkersThe reason for pursuing the STTR mechanism is two foldwhile
NPI has been able to produce enough product for our modest clinical studiesthey are not in a position to ramp
up full production in order to support larger scale clinical trialsandwe have conducted and publishedstudies in human subjectsbut we have yet to conduct a study in heavy drinkers who are alcohol dependent
and are treatment seekingThusthere is a significant need for this clinical trial to demonstrate efficacy in this
important populationThe reason for the Fast Track approach is that we have already developed productlicensed it to NPIand have the backbone of a commercialization planbut need fiscal support to develop the
processes needed to increase production of enough standardized product to support not only the clinical trialbut to be able to meet the needs once the commercialization plan is implementedThus Phase I will be
focused on providing NPI with the infrastructure to scale up production of standardizedhigh quality Alkontrolherbal
while the clinical trial will be the major milestone of Phase IICollectivelysuccessful completion of these
two phases will pave the way for the commercialization of Alkontrol herbalKey milestones for Phase I includeprocure and authenticate Pueraria lobata from our source in Chinaperform GMP extraction and precipitationdevelop independent QC analytical protocolsoptimize ratio of isoflavonesand finalize submission of an IND
for FDA approved labeling and IRB applicationsPhase II milestones includescale up production of Alkontrolherbalisolate puerarin for standardizationdevelop a urinary biomarker for medication adherence and conduct
proof of concept clinical trial in treatment seeking alcohol dependent individuals