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A POTENTIAL NEW DRUG FOR DEPRESSION

Award Number: R44MH063663
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/01/2001
PERIOD OF PERFORMANCE END DATE: 08/31/2011

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A POTENTIAL NEW DRUG FOR DEPRESSION - DESCRIPTION (provided by applicant): Vasopressin (AVP) antagonists represent a novel therapeutic class for the treatment of depression. The potential utility of these compounds has emerged from observations in depressed individuals, findings in animal models, and an understanding of changes in hypothalamic-pituitary-adrenal (HPA) axis regulation under chronic stress. This proposal seeks continued support for the development of SRX246-HCl, a novel vasopressin 1a (V1a) receptor antagonist that has shown efficacy in preclinical animal models of depression and anxiety, good plasma bioavailability and CNS penetration following oral administration, a strong safety profile, and high affinity and selectivity for the target receptor. The scientific basis for V1a antagonists as a pharmacotherapy for depression includes: 1) the neuroadaptation and dysregulation of HPA function that accompanies chronic stress in affected humans and in animal models of depression, 2) recognition that AVP, not CRF, drives HPA function associated with chronic psychological stress, 3) the CNS localization of V1a receptors in limbic system regions involved in HPA regulation and control of social behaviors, and 4) preclinical data with SRX246 showing efficacy in animal models employed as screens for antidepressant/anxiolytic activity. The development of SRX246 to date has been supported by SBIR Phase I and II grants, the National Toxicology Evaluation program, and a Series A private sector investment. Phase IIa support will enable a Phase I Clinical Trial to establish safety and tolerability in humans and continued development of back-up compounds. Positive results from these efforts will accelerate commercialization opportunities by significantly advancing the likelihood of a partnership with a major pharmaceutical house and/or additional private sector investment. The public health need for new pharmaceutical treatments for depression is well documented. Depression affects some 20 million Americans each year and carries a conservatively estimated annual total economic burden of $80 billion. Existing drugs for depression are not uniformly effective and frequently have undesirable side effects. These limitations demonstrate that a new treatment approach through V1a receptor antagonism may offer significant opportunities for improved outcomes with substantial societal benefit.


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: 2010 ( Subtotal = $0 )
2010	2009	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	8	9/3/2010	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2009 ( Subtotal = $1,021,700 )
2009	2009	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Trans-NIH Recovery Act Research Support	002	8	9/29/2009	SUPPLEMENT FOR EXPANSION	$226,385
2009	2009	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	001	8	8/11/2009	NON-COMPETING CONTINUATION	$795,315
2009	2008	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	7	6/22/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,021,700

Issue Date FY: 2008 ( Subtotal = $797,078 )
2008	2008	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	7	8/30/2008	NON-COMPETING CONTINUATION	$797,078
														Subtotal = $797,078

Issue Date FY: 2007 ( Subtotal = $801,007 )
2007	2007	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	6	8/29/2007	COMPETING CONTINUATION	$801,007
														Subtotal = $801,007

Issue Date FY: 2006 ( Subtotal = $449,093 )
2006	2006	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	5	8/21/2006	NON-COMPETING CONTINUATION	$449,093
														Subtotal = $449,093

Issue Date FY: 2005 ( Subtotal = $449,073 )
2005	2005	AZEVVAN PHARMACEUTICALS INC	111 RESEARCH DRIVE	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	3	9/21/2005	NON-COMPETING CONTINUATION	$449,073
														Subtotal = $449,073

Issue Date FY: 2004 ( Subtotal = $449,054 )
2004	2004	SERENIX PHARMACEUTICALS	111 RESEARCH DRIVE B217	BETHLEHEM	PA	18015	NORTHAMPTON	USA	Mental Health Research Grants	000	2	8/31/2004	COMPETING CONTINUATION	$449,054
														Subtotal = $449,054

Grand Total All Awards = $3,967,005

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A POTENTIAL NEW DRUG FOR DEPRESSION

Award Number: R44MH063663

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/01/2001

PERIOD OF PERFORMANCE END DATE: 08/31/2011

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