NEW YORK, June 5, 2015 /PRNewswire/ — Yesterday’s FDA Advisory Committee recommendation for the approval of flibanserin was a landmark step for women’s health, addressing the important unmet medical need for women living with hypoactive sexual desire disorder, or HSDD. We are especially pleased for S1 Biopharma’s Dr. Robert Pyke who fathered flibanserin at Boehringer Ingelheim before it was acquired by Sprout Pharmaceuticals. Dr. Pyke joined S1 Biopharma as Chief Medical Officer in 2012 to develop our next-generation drug for HSDD, Lorexys.
HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity that cannot be accounted for by another medical, physical, or psychiatric condition, or medication. An estimated 1 in 10 women may have HSDD at some point in their life, for which therapies like flibanserin with a 9%- 13% responder rate over placebo, and S1 Biopharma’s first in class, next-generation drug Lorexys have been developed to address.
S1 Biopharma is currently preparing for upcoming Phase IIb studies for Lorexys for the treatment of HSDD. In its recently completed Phase IIa study, Lorexys demonstrated a 76% responder rate that was 38% greater than control.
About S1 Biopharma
S1 Biopharma is a developer of first-in-class drugs for sexual dysfunction in both women and men. The company’s pipeline of therapies is non-hormonal, acting on the sexual centers of the brain by restoring the natural balance of key neurotransmitters. S1 Biopharma’s pipeline utilizes its trademark philosophy of identifying and combining mechanistically opposing agents that work synergistically to maximize beneficial effects on sexual function while minimizing side effects. The company’s lead compound, Lorexys, recently completed a Phase IIa clinical trial for the treatment of hypoactive sexual desire disorder (HSDD).