S1 Biopharma’s first-in-class lead product, Lorexys, targets hypoactive sexual desire disorder (HSDD) in women, the most common type of female sexual dysfunction. Lorexys is designed to restore the balance of three neurotransmitters – dopamine, serotonin and norepinephrine – that are known to regulate sexual inhibition and sexual excitation. An oral, non-hormonal, fixed-dose combination of two antidepressants, bupropion and trazodone, Lorexys is formulated with a ratio that is precisely balanced to neutralize the side effects of its individual components and maximize efficacy.
Lorexys is well-positioned to progress toward FDA approval. The FDA has granted it 505(b)(2) status, allowing an accelerated path to product approval because its components are already FDA-approved and have established safety records. This lowers development costs and reduces both developmental and regulatory risk. S1 Biopharma’s sophisticated trial designs address challenges in the measurement of patient-reported outcomes. Lorexys’ clinical development plan anticipates FDA requests for data on issues such as drug-drug or drug-alcohol interactions.
Lorexys has completed a Phase 2a clinical study that evaluated its safety, tolerability and pro-sexual efficacy as compared to bupropion, one of its constituent drugs.