pipeline

The Company has selected as its lead clinical candidates two compounds (SRX251 and SRX246) that selectively and specifically block the V1a receptor.

Phase I clinical studies with SRX251 were completed in 2008, establishing safety and tolerability. SRX251 is being developed for women’s health, with a strategic focus on menstrual-related disorders (Primary Dysmenorrhea) and Raynaud’s Disease. Primary Dysmenorrhea, defined by pelvic pain and discomfort, also can trigger stress or anxiety. In its most severe form, premenstrual dysphoria/dysmenorrhea, the pelvic pain and discomfort is accompanied by depression. The prevalence of Primary Dysmenorrhea in women between18-50 is estimated at 40%. Premenstrual Syndrome (PMS) and Premenstrual Dysphoric Disorder (PMDD) are observed in 20% and 5% of premenopausal women, respectively, and can co-occur with Primary Dysmenorrhea. Raynaud’s Disease, a vasospastic disorder defined by severe pain and discoloration in the extremeties, is five times more prevalent in women and is associated with emotional stress. The ability of SRX251 to cross the blood-brain barrier provides, through V1a receptor antagonism, a unique approach for treating both peripheral pain and CNS disorders.

SRX246 is under development as a novel therapeutic for stress-related affective illness. An IND was submitted for the treatment of anxiety in Q2 2009. Pre-clinical studies with this compound were supported by the National Institutes of Health through the National Toxicology Evaluation Program, the NIH RAID Program, and SBIR grants. In the U.S. alone, anxiety and depression affect over 35 million people and pharmaceutical treatments represent an estimated $25 billion annual market.