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S1 Biopharma Doses First Patients in Phase 2a Clinical Trial of Lorexys in Premenopausal Women with HSDD
Date:7/29/2013

JERSEY CITY, N.J., July 29, 2013 /PRNewswire/ -- S1 Biopharma, Inc., a developer of first-in-class drugs for sexual dysfunction in women and men, today announced enrollment and dosing of premenopausal women with hypoactive sexual desire disorder (HSDD) in the Phase 2a clinical trial of its leading drug candidate Lorexys (S1P-104).  

"The initiation of this study marks a significant milestone for S1 Biopharma as we advance Lorexys' clinical development," said Nicolas G. Sitchon, chief executive officer of S1 Biopharma. "Despite significant effort over many years, there are no FDA-approved treatments for women with HSDD. We believe Lorexys may provide the first safe and effective treatment option for those whose lives and the lives of their partners are affected by the disorder. By restoring the balance of the key neurotransmitters that regulate sexual desire in the brain we expect that Lorexys will help women with sexual desire and arousal disorders regain a healthy sexual life."

The leading scientific model of the regulation of sexual desire in the brain is the Kinsey dual control model. It explains that sexual inhibition and sexual excitation are kept in balance by activating and inhibiting neurotransmitters including serotonin, norepinephrine and dopamine.

"Lorexys, which is a first-in-class drug for HSDD, was formulated by identifying the two psychiatric medications, bupropion and trazodone, that, when combined in a precise, proprietary ratio, would modulate the activity of these neurotransmitters, neutralize the monoamine modulators' side effects and maximize beneficial effects on sexual function," said Robert E. Pyke, M.D., Ph.D., chief medical officer of S1 Biopharma. "Pilot data supported positive effects, unlike other serotonergic agents or combinations studied in our early drug development. S1P-205,
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SOURCE S1 Biopharma, Inc.
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