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TRANSDERMAL CANNABINOID PRODRUG TREATMENT FOR CANNABIS WITHDRAWAL AND DEPENDENCE

Award Number: RC2DA028984
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2009
PERIOD OF PERFORMANCE END DATE: 08/31/2013

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TRANSDERMAL CANNABINOID PRODRUG TREATMENT FOR CANNABIS WITHDRAWAL AND DEPENDENCE - DESCRIPTION (provided by applicant): Cannabis use disorders affect approximately 1.5% of the United States population, and more than half of the individuals addicted to marijuana experience significant withdrawal symptoms if they try to quit, which contributes to the relapse and maintenance of marijuana use. AllTranz is seeking funding to create a transdermal delivery system of delta-9-tetrahydrocannabinol (THC) as an adjunct treatment for marijuana withdrawal and dependence. While the approved THC (Marinol) capsule provides potentially effective treatment for cannabis use disorders, oral drug delivery is not desirable because of the peak plasma level related side effects and short duration of action. The transdermal system would be a non-invasive non-oral dosage form with ultimate dosing/duration flexibility, and also have fewer drug side effects (i.e. no THC plasma peak level related euphoria). Initial positive preliminary data has encouraged AllTranz to seek funding to develop new THC prodrugs and optimize their use through a transdermal drug delivery system. Prodrugs are chemically modified parent drugs that are more skin permeable than the parent, and once they cross the stratum corneum quickly separate back into the parent drug and prodrug moiety. Transdermal formulations also provide more abuse deterrence than immediate release dosage forms. Transdermal delivery systems offer a number of improvements over other delivery systems. Patches and gels do not require swallowing, eliminating oral side effects and bitter taste concerns; nor do they require skin puncture by needles, eliminating pain and patient visits to a physician. Permeation through the skin allows the drug to directly enter the systemic circulation and avoid the first pass effect, decreasing gastric side effects and liver damage effects in hepatocompromised drug abusers. Specifically we aim to synthesize skin permeable prodrugs of THC. We then aim to assess their in vitro human skin permeation for optimum flux. The optimal prodrugs will be evaluated for chemical stability and performance in adhesive patch formulations. The best prodrug candidate will undergo synthesis scale-up optimization, prototype patches will be manufactured, and preclinical toxicology testing will be completed. An IND will be submitted to the FDA so that a Phase I clinical trial can be completed. A proof of concept study in marijuana withdrawal can be completed under this two-year plan. We will create a marketable transdermal drug that will significantly aid in the treatment of marijuana dependence and withdrawal. PUBLIC HEALTH RELEVANCE: Cannabis use disorders affect approximately 1.5% of the United States population, and more than half of the individuals addicted to marijuana experience significant withdrawal symptoms if they try to quit, which contributes to the relapse and maintenance of marijuana use. AllTranz is seeking funding to create a transdermal delivery system of THC as an adjunct treatment for marijuana withdrawal and dependence. The transdermal system would be a non-invasive non-oral dosage form with ultimate dosing flexibility, and also have fewer drug side effects (i.e. no THC plasma peak level-related euphoria).


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: 2012 ( Subtotal = $0 )
2012	2010	ALLTRANZ INC	4080 WEBER WAY	LEXINGTON	KY	40514	FAYETTE	USA	Trans-NIH Recovery Act Research Support	000	2	5/9/2012	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2010 ( Subtotal = $1,932,519 )
2010	2010	ALLTRANZ INC	4080 WEBER WAY	LEXINGTON	KY	40514	FAYETTE	USA	Trans-NIH Recovery Act Research Support	000	2	9/17/2010	NON-COMPETING CONTINUATION	$1,932,519
														Subtotal = $1,932,519

Issue Date FY: 2009 ( Subtotal = $2,080,746 )
2009	2009	ALLTRANZ INC	4080 WEBER WAY	LEXINGTON	KY	40514	FAYETTE	USA	Trans-NIH Recovery Act Research Support	000	1	9/30/2009	NEW	$2,080,746
														Subtotal = $2,080,746

Grand Total All Awards = $4,013,265

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TRANSDERMAL CANNABINOID PRODRUG TREATMENT FOR CANNABIS WITHDRAWAL AND DEPENDENCE

Award Number: RC2DA028984

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2009

PERIOD OF PERFORMANCE END DATE: 08/31/2013

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