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Phase II clinical evaluation of Omnitram in neuropathic pain

Award Number: R44DA040378
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2015
PERIOD OF PERFORMANCE END DATE: 07/31/2020

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Phase II clinical evaluation of Omnitram in neuropathic pain - ¿ DESCRIPTION (provided by applicant): Neuropathic pain is caused by damage to the peripheral nerves, as occurs in diabetic neuropathy. Neuropathic pain is difficult to treat, and many patients have pain that is refractory to existing treatments. Omnitram is a novel mixed-mechanism analgesic developed by Syntrix that consists of the (-) and (+) enantiomers of O-desmethyltramadol. The (+)-enantiomer is a potent µ-opioid receptor agonist, while the (-)- enantiomer is a norepinephrine reuptake inhibitor that synergizes with the (+)-enantiomer. Omnitram is inherently an opioid-sparing opioid-adjuvant combination therapy that is predicted to have low abuse potential. O-desmethyltramadol is the primary metabolite (M1) of tramadol. Omnitram provides the same net pharmacology as tramadol, but in contrast to tramadol, does not require metabolism by cytochrome P450 2D6 (CYP2D6) for its activity (i.e. it is metabolism-independent). Individuals who are CYP2D6 poor metabolizers (PMs) fail to obtain pain relief from tramadol. The "real world" incidence of CYP2D6 PM status in patients on polypharmacotherapy is as high as 1 in 3. Omnitram is therefore an opportunity to develop an "improved tramadol" that is effective in all patients irrespective of their CYP2D6 metabolic status. Omnitram successfully completed a Phase 1b randomized, double-blind, placebo-controlled trial that demonstrated Omnitram provided significant analgesia compared to placebo in an experimental pain model in healthy subjects. This Fast-Track application aims to further the success of the Omnitram program by demonstrating analgesic efficacy in patients suffering from neuropathic pain due to diabetic neuropathy. A Cochrane systematic review concluded that tramadol is an effective treatment for neuropathic pain with efficacy similar to that reported for antidepressants and anticonvulsants. Omnitram provides the same net pharmacology as tramadol and is therefore predicted to be efficacious in treating neuropathic pain.


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	2017	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	3	3/24/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	3	7/30/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $657,180 )
2017	2017	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	001	3	7/12/2017	NON-COMPETING CONTINUATION	$657,180
2017	2015	SYNTRIX BIOSYSTEMS, INC.	215 CLAY ST NW STE B-5	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	1	2/3/2017	NEW	$0
														Subtotal = $657,180

Issue Date FY: 2016 ( Subtotal = $842,819 )
2016	2016	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	2	7/18/2016	EXTENSION WITH OR WITHOUT FUNDS	$842,819
														Subtotal = $842,819

Issue Date FY: 2015 ( Subtotal = $224,997 )
2015	2015	SYNTRIX BIOSYSTEMS INC	215 CLAY STREET NW	AUBURN	WA	98001	KING	USA	Drug Use and Addiction Research Programs	000	1	7/21/2015	NEW	$224,997
														Subtotal = $224,997

Grand Total All Awards = $1,724,996

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Phase II clinical evaluation of Omnitram in neuropathic pain

Award Number: R44DA040378

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2015

PERIOD OF PERFORMANCE END DATE: 07/31/2020

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