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Pivotal Study For PSD502 — The First Potential Treatment For Premature Ejaculation

November 19, 2009

On-demand aerosol spray increased ejaculatory latency

At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC (“Plethora” ““ AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE). Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo. Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.

An estimated one-third of U.S. men ages 18 – 59 are affected by PE, making it twice as prevalent as erectile dysfunction. Currently, there are no prescription therapies approved in the U.S. to treat PE.

PSD502, a product in development for the treatment of PE, is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed by a metered dose aerosol. PSD502 works selectively on non-keratinized skin on the glans penis (head of the penis).

“Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners,” said Professor Stanley E. Althof, PhD, Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida. “Recently, the international sexual health community agreed that PE should be defined as ejaculation occurring within approximately one minute of penetration that causes the patient distress. Now we need to work to develop treatments, and these encouraging results with PSD502 seem to be a step in the right direction.”

Both pivotal trials showed clinically and statistically significant efficacy in the treatment of premature ejaculation, as measured by changes in Intravaginal Ejaculatory Latency Time (IELT) and Index of Premature Ejaculation (IPE), a patient-reported outcome of ejaculatory control, sexual satisfaction, and distress.

“We are excited that results from two pivotal studies have shown that PSD502 was effective for men with PE, and we look forward to the opportunity to help patients who have had no real options to date,” said Patrick Fourteau, Chief Executive Officer of Sciele Pharma, Inc. “This data will support the New Drug Application for PSD502 that we are planning to submit to the U.S. Food & Drug Administration (FDA), which upon FDA approval would make PSD502 be the first prescription treatment in the U.S. for premature ejaculation.”

Pivotal Study Details

The new study, the second of two major pivotal trials, was designed to assess the clinical benefit and safety of PSD502 in men with PE. The trial, which randomized 256 patients across 38 investigational centers in the U.S., Canada and Poland, also assessed the safety and tolerability of the therapy. Final analyses of the three months data confirmed that PSD502 produced a clinically and statistically significant increase from baseline in all study primary and secondary endpoints. The time for IELT for PSD502 group increased 4.7-fold compared to 1.5-fold in placebo (p< 0.0001), resulting in a geometric mean IELT of 2.6 minutes in the PSD502 group and 0.8 minutes in the placebo group.

There were improvements in IPE scores in the PSD502 group, which recorded patient and partner feedback, compared to placebo, resulting in 5.0-, 4.6- and 2.5-point differences between PSD502 and placebo in ejaculatory control, satisfaction and distress domains, respectively (p<0.0001 between treatment comparisons).

Overall, PSD502 was well-tolerated, with no serious adverse events reported by patients or partners in the studies.

Also presented for the first time at SMSNA were two subset analyses of the European Phase III trial data showing:

    * Increased ejaculatory latency and improvements in patent-reported outcomes seen in the first month of use with PSD502 were maintained over two to three months of treatment; and
    * A significant positive correlation between mean IELT and IPE domain scores after three months of treatment, indicating that increases in IELT are associated with improvements in patient-reported outcomes.

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