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Biopharmaceuticals FDA

 News Release - August 20, 2015

S1 Biopharma Supports FDA Approval of First-Ever Treatment for Hypoactive Sexual Desire Disorder

NEW YORK, Aug. 20, 2015 -- (Healthcare Sales & Marketing Network) -- S1 Biopharma is a developer of first-in-class drugs for sexual dysfunction in both women and men. The company's lead compound, Lorexys, is currently in Phase IIb for the treatment of hypoactive sexual desire disorder (HSDD).

Tuesday's approval of flibanserin by the U.S. Food and Drug Administration (FDA) was a significant advancement for women's health, addressing the important unmet medical need for women living with HSDD. The condition is marked by a lack of sexual thoughts and desire for sexual activity that cannot be accounted for by another medical, physical, psychiatric, or medication-induced condition. An estimated one in 10 women may have HSDD at some point in their life, for which therapies like flibanserin and Lorexys, S1 Biopharma's next-generation first in class drug, are being developed to address.

We are pleased for Dr. Robert Pyke, who before joining S1 Biopharma as Chief Medical Officer in 2012 to develop Lorexys, had fathered flibanserin at Boehringer Ingelheim before it was acquired by Sprout Pharmaceuticals.

S1 Biopharma, Inc. is continuing the development of Lorexys, a unique multi-receptor oral tablet being studied for the treatment of HSDD in pre-menopausal women. Lorexys will provide first-line treatment for women suffering from HSDD as an easy to administer daily pill.

With a novel mechanism, which modulates pathways in the brain already proven to be involved in sexual response, Lorexys is designed to help a majority of patients achieve meaningful response. In its Phase IIa study, 76% of women responded to Lorexys, a 38% improvement over active control. Unlike flibanserin, with a 9%- 13% responder rate over placebo, or other FSD treatments in development, Lorexys appears to help a large majority of patients achieve meaningful response. This meaningful response has a wide margin of efficacy over control treatment and restores women's sexual desire rather than serve as a mild aid. Also important, the proprietary ratio of ingredients in Lorexys has helped women achieve remission rapidly, in a month or less. In contrast to other treatments, in its Phase IIa studies Lorexys was not associated with dropouts related to drowsiness, dizziness or nausea. Lorexys is planned to be the most personalized treatment available. To optimize dosage for every woman, more than one strength is available. It can also be taken in combination with social alcohol consumption or other medications. Lorexys is expected to be an effective and broadly applicable treatment option among those women suffering from HSDD.

S1 Biopharma looks forward to upcoming clinical trials expected to bring Lorexys closer to approval as a treatment for HSDD, expanding the HSDD marketplace. This coming year, S1 Biopharma expects to start enrolling pre-menopausal women with HSDD in Phase IIb trials for Lorexys. Each of the eight-week parallel-group trials will be multicenter, randomized, and placebo controlled. An open-label extension study is anticipated for those who complete treatment in the parent trial. The clinical trials are designed to randomize a total of at least 300 women to evaluate the efficacy and safety of Lorexys in premenopausal women with HSDD. More information on the trial protocol, including trial design and inclusion/exclusion criteria, will soon appear at

About HSDD and Sexual Interest and Arousal Disorder

The DSM-IV defines HSDD as a lack or absence of sexual fantasies and desire for sexual activity, as judged by a clinician, which causes marked distress or interpersonal difficulties. ICD-9 and the upcoming ICD-10 also recognize HSDD, though in DSM-5 female sexual arousal and desire disorders are combined into female sexual interest/arousal disorder. Both the DSM-IV and DSM-5 diagnostic categories require that a patient experience significant distress resulting from a loss in desire and arousal. In a U.S. study of 30,000 women, it was found that 10% met these criteria for HSDD without depression or other possible causes.

About Lorexys

Lorexys is being investigated as a first-in-class drug for HSDD. An oral, non-hormonal fixed-dose combination of two antidepressants, bupropion and trazodone, Lorexys is precisely formulated to restore the balance of three neurotransmitters modulating desire in the sexual centers of the brain. These neurotransmitters, dopamine, serotonin and norepinephrine, are known to regulate sexual inhibition and sexual excitation. Lorexys is also formulated to neutralize the monoamine modulators' side effects.

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, is currently in a Phase IIb clinical trial for the treatment of hypoactive sexual desire disorder (HSDD).

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Source: S1 Biopharma

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