US-based biotechnology firm Strategic Science and Technologies (SST) has started a Phase I trial of its product candidate SST-6006 to treat women with female sexual arousal disorder (FSAD).

SST-6006 is a first-in-class topical sildenafil product candidate currently being developed for the treatment of sexual health conditions in both men and women.

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The trial is designed to evaluate the safety, tolerability and pharmacokinetics of SST-6006 in healthy, post-menopausal women following a single dose applied topically to the vaginal tissue.

"This marks an important milestone for the treatment of FSAD, a significant unmet and under discussed need for many women."

The company said that a single centre, open-label, placebo-controlled, within-subject dose-escalation trial design will be used to assess three dose levels of SST-6006.

In the trial, safety evaluations will include physical examination, clinical laboratory evaluations, ECG, and adverse events.

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In order to determine concentrations of sildenafil in plasma, pharmacokinetic analyses will be completed at pre-specified time points from pre-dose up to 32 hours post-dose.

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In nonclinical and clinical studies conducted in healthy men, the topical application of SST-6006 has resulted in very low systemic absorption of sildenafil, compared to a comparable oral dose of sildenafil, providing the potential to reduce the side effects long associated with oral phosphodiesterase type-5 (PDE-5) inhibitors.

SST scientific founder and chief executive officer Eric Fossel said: "Based on the positive results in the Phase I trial in men, we are excited to begin our clinical evaluation of SST-6006 in women with FSAD. This marks an important milestone for the treatment of FSAD, a significant unmet and under discussed need for many women.

"With SST-6006’s novel topical delivery and potential review by the FDA as an over-the-counter product, we believe it could be a groundbreaking new therapy that positively impacts sexual health in both men and women."

The company aims to show that SST-6006 is a safe and effective treatment for women with FSAD, and intends to pursue potential registration of SST-6006 as an over-the-counter (OTC) topical product.

SST-6006 is developed using the company’s KNOSIS technology, a patented topical cream product containing 5% sildenafil citrate by weight.

Women of all ages are affected by FSAD, which is a disorder characterised by a persistent or recurrent inability to attain sexual arousal or to maintain arousal until the completion of a sexual activity.