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Plethora Clinical Update – Positive Outcomes from Final Phase III Pivotal Trial of PSD502 for Premature Ejaculation.
• Statistically and Clinically Significant Increase in all Co-primary Endpoints
• Well Tolerated and Devoid of Systemic Side Effects
London UK, July 29th, 2009 - Plethora Solutions Holdings PLC ("Plethora", AIM: PLE), the specialist developer of products for the treatment and management of urological disorders, announces that the second and final Phase III double-blind placebo controlled study of PSD502 for the treatment of premature ejaculation (PE) has met all co-primary endpoints of Intra-vaginal Ejaculation Latency Time (‘IELT), Index of Premature Ejaculation (‘IPE’; Ejaculatory Control and Sexual Satisfaction domains) and Distress.
This successful study, involving patients from the USA, Canada and Europe, is one of two pivotal Phase III studies which were run in parallel with identical protocols. The previously announced Phase III study was conducted entirely in Europe and its successful outcome was reported in November 2008. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
Phase III Study Details:
Each Phase III study was a multi-centre, randomised, double blind, placebo-controlled efficacy study which recruited a total of 540 patients across the two studies. Patients were treated for a 12 week period with an optional open label phase of up to 9 months.
Outcome of Second Phase III Study:
Entirely consistent with the first study, analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all co-primary study endpoints. The intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with PSD502 when compared to baseline (p<0.0001). There was a 5 point difference between PSD502 and placebo in the IPE domains for Ejaculatory Control and Sexual satisfaction (p<0.0001), where a 2 point difference is considered clinically significant. As a secondary endpoint, partner satisfaction, was also found to be considerably greater with PSD502 than placebo.
The incidence of serious adverse events and overall side effect incidence were similar in the PSD502 and placebo group. Overall, PSD502 was well tolerated and there were no systemic adverse events. As previously, a very low incidence of mild penile numbing (<3%) was observed.
About PSD502:
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation; a disorder affecting between 25% and 30% of men in the USA and Europe.
In May 2007, Plethora signed an exclusive license agreement with Sciele Pharma, Inc., (‘Sciele’) a subsidiary of Shionogi Corporation, to market PSD502 for premature ejaculation in the USA. In May 2009 Sciele acquired global rights to the product.
Ed Schutter, President and Chief Operating Officer of Sciele Pharma, said, “We are pleased with these initial Phase III efficacy results in this final Study for PSD502, which, upon FDA approval, would be the first prescription treatment in the United States for premature ejaculation.”
The Principal Investigator, Dr Culley Carson, Rhodes Professor of Urology, University of North Carolina, commented; “These are highly clinically significant results that show PSD502 is likely to be of considerable benefit to both patient and partner. Particularly pleasing is the ability to take the product on demand.”
Dr Mike Wyllie, CSO of Plethora, said: “We are delighted with these highly significant results from the second and final Phase III clinical study which reinforce the results from the European Phase III trial. This represents an important milestone in the regulatory submission process.”
About Plethora:
Plethora is focused on the development and marketing of products for the treatment of urological disorders. The Company has products in clinical development for the treatment of overactive bladder (PSD506), stress urinary incontinence (PSD503), interstitial cystitis (PSD597), gynaecological pain (PSD508), erectile dysfunction (PSD510) and premature ejaculation (PSD502). The Company is headquartered in the UK and is listed on the London Stock Exchange (AIM:PLE)
Further information is available at www.plethorasolutions.co.uk
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