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Overcoming Tramadol Resistance In CYP2D6 Poor Metabolizers: A Phase 1 Trial Demonstrating Analgesic Superiority of Omnitram to Tramadol in Subjects Coadministered Paroxetine

Award Number: R44DA027304
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2010
PERIOD OF PERFORMANCE END DATE: 08/31/2020

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Overcoming Tramadol Resistance In CYP2D6 Poor Metabolizers: A Phase 1 Trial Demonstrating Analgesic Superiority of Omnitram to Tramadol in Subjects Coadministered Paroxetine - ¿ DESCRIPTION (provided by applicant): From 2009-2013 the utilization of the Schedule II opioids codeine, OxyContin and fentanyl declined significantly, down about 14.0% for all three drugs. In sharp contrast, the use of tramadol, a Schedule IV controlled substance, increased 32.5%. Schedule IV substances have low potential for abuse and harm relative to Schedule II substances, and the fortuitous trend to tramadol has reduced the use of the relatively unsafe Schedule II opioids dramatically. Tramadol is a weak opioid-adjunct combination that is recognized as having a better safety profile and less abuse potential than Schedule II opioids (e.g., oxycodone. tapentadol). Unfortunately, tramadol suffers from a critical shortcoming. Tramadol requires metabolic activation for efficacy, and individuals who are CYP2D6 poor metabolizers (PMs) fail to obtain pain relief. The "real world" incidence of CYP2D6 PM status in clinical practice has been shown to be as high as 1 in 3. Tramadol resistance due to CYP2D6 PM status is a shortcoming that results in a significant negative impact on patient care, and that erodes the entire utility of tramadol as a safer alternative to Schedule II opioids. There exists a significant need for an "improved tramadol" that would have the same inherent safety but be effective in all patients irrespective of their metabolic status. Omnitram is a novel mixed-mechanism analgesic developed by Syntrix that is an opioid-adjunct analgesic combination consisting of the enantiomers of O-desmethyltramadol, the active metabolite of tramadol. Omnitram provides the same net pharmacology as tramadol, but in contrast to tramadol, does not require metabolism by CYP2D6 for its activity. Omnitram broadly increases the utility of tramadol, and would leverage and accelerate the shift in prescribing trends away from the relatively unsafe Schedule II opioids. This proposal aims to demonstrate that Omnitram analgesia is superior to tramadol analgesia in otherwise healthy CYP2D6 deficient subjects. Success in this in-patient Phase 1b clinical trial will provide direct support for Omnitram's advantages in clinical pain states in CYP2D6 deficient patients.


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: 2021 ( Subtotal = $0 )
2021	2018	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	7	3/24/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $977,024 )
2018	2018	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	7	8/14/2018	NON-COMPETING CONTINUATION	$977,024
														Subtotal = $977,024

Issue Date FY: 2017 ( Subtotal = $997,596 )
2017	2017	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	001	6	7/27/2017	NON-COMPETING CONTINUATION	$997,596
2017	2014	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	4	7/25/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $997,596

Issue Date FY: 2016 ( Subtotal = $990,418 )
2016	2016	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	5	8/22/2016	COMPETING CONTINUATION	$990,418
														Subtotal = $990,418

Issue Date FY: 2014 ( Subtotal = $583,069 )
2014	2014	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	4	8/15/2014	NON-COMPETING CONTINUATION	$583,069
														Subtotal = $583,069

Issue Date FY: 2013 ( Subtotal = $1,040,927 )
2013	2013	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	001	3	8/5/2013	NON-COMPETING CONTINUATION	$933,466
2013	2012	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	2	12/19/2012	COMPETING CONTINUATION	$107,461
														Subtotal = $1,040,927

Issue Date FY: 2012 ( Subtotal = $466,668 )
2012	2012	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	2	7/27/2012	COMPETING CONTINUATION	$466,668
														Subtotal = $466,668

Grand Total All Awards = $5,055,702

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Overcoming Tramadol Resistance In CYP2D6 Poor Metabolizers: A Phase 1 Trial Demonstrating Analgesic Superiority of Omnitram to Tramadol in Subjects Coadministered Paroxetine

Award Number: R44DA027304

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2010

PERIOD OF PERFORMANCE END DATE: 08/31/2020

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