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Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse

Award Number: R43DA050395
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2020

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Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse - PROJECT SUMMARY / ABSTRACT With nearly 116 mln people suffering from chronic pain in the US alone and the global market projected to reach $83 bln by 2024, there is both a major unmet medical need and a significant commercial opportunity. Dominated by opioid drugs, this field also suffered from alarming consequences of opioid drug overuse and misuse. Antagonists acting at TRPV1 receptor have long been recognized as one of the most promising novel classes of non-opioid analgesics. Several drug companies have developed highly selective and potent compounds. Initial tests in humans have confirmed pharmacodynamic profile expected for this class of agents (i.e. analgesia). However, despite an overall good safety and tolerability, there were significant effects on thermoregulation resulting in clinically meaningful hyperthermia and partial loss of heat sensitivity. These effects have led to the discontinuation of essentially all of the advanced programs in the field of TRPV1 antagonists. In this regard, and in line with funding opportunity RFA-DA-19-019, the current application proposes to conduct a set of preclinical proof of concept studies in rats to support the claims that, at doses that have minimal, clinically acceptable or negligible impact on cardiovascular function, a2 adrenoceptor agonists can diminish thermoregulatory effects of TRPV1 receptor antagonists. In Phase 1, we will demonstrate that (Aim 1) presynaptically acting a2 adrenoceptor agonists such as lofexidine can prevent or diminish the hyperthermic responses to TRPV1 receptor antagonists; (Aim 2) at the doses controlling thermoregulatory effects of TRPV1 receptor antagonists, a2 adrenoceptor agonists have minimal or acceptable effects on hypotension.


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: 2020 ( Subtotal = $0 )
2020	2019	SYNVENTA LLC	5117 N FAIRWAY HEIGHTS DR	TUCSON	AZ	85749	PIMA	USA	Drug Use and Addiction Research Programs	000	1	9/20/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $222,276 )
2019	2019	SYNVENTA LLC	5117 N FAIRWAY HEIGHTS DR	TUCSON	AZ	85749	PIMA	USA	Drug Use and Addiction Research Programs	001	1	9/17/2019	NEW	$0
2019	2019	SYNVENTA LLC	5117 N FAIRWAY HEIGHTS DR	TUCSON	AZ	85749	PIMA	USA	Drug Use and Addiction Research Programs	000	1	9/16/2019	NEW	$222,276
														Subtotal = $222,276

Grand Total All Awards = $222,276

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Fixed dose analgesic combination with non-opioid mechanism to prevent opioid misuse

Award Number: R43DA050395

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/30/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2020

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