29th Jul 2009 07:00
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For Immediate Release |
29th July 2009 |
PLETHORA SOLUTIONS HOLDINGS PLC
Clinical Update - PSD502 for Premature Ejaculation
Positive Outcomes from Final Phase III Pivotal Trial
Statistically and Clinically Significant Increase in all Co-primary Endpoints
Well Tolerated and Devoid of Systemic Side Effects
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 point difference between PSD502 and placebo in the IPE domains for Ejaculatory Control and Sexual satisfaction (p, 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 (
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."
-Ends-
Enquiries:
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Plethora Solutions Steven Powell |
Tel : +44(0) 20 3077 5400 |
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FinnCap Geoff Nash/Marc Young |
Tel : +44(0) 20 7600 1658 |
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Hansard Group Adam Reynolds/John Bick |
Tel: +44(0) 20 7245 1100 |
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
About Sciele Pharma, Inc.
Sciele Pharma, Inc., a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of Cardiovascular, Diabetes, Women's Health and Pediatrics. The Company's Cardiovascular and Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its Pediatrics products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Georgia, Sciele employs more than 1,000 people. The Company's success is based on placing the needs of patients first, improving health and quality of life, and implementing its business platform - an Entrepreneurial Spirit, Innovation, Execution Excellence, Simplicity, and Teamwork.
On October 9, 2008, Shionogi & Co., Ltd. and Sciele Pharma announced the completion of Shionogi's acquisition of Sciele. Sciele is now an indirect wholly owned subsidiary of Shionogi.
About Shionogi & Co., Ltd.
Shionogi & Co., Ltd. is a major research-driven Japanese pharmaceutical manufacturer. The company's primary businesses are research and development, manufacturing, marketing, and import and export sales of pharmaceuticals and diagnostics. Shionogi follows a basic policy of continually providing the superior medicines essential to people's health. For more details, please visit www.shionogi.co.jp.
Safe Harbor Statement
This press release contains forward-looking statements that are subject to risks and uncertainties that could cause actual results to materially differ from those described. Although we believe that the expectations expressed in these statements are reasonable, we cannot promise that our expectations will turn out to be correct. Our actual results could be materially different from and worse than our expectations.
CONTACT: Sciele Pharma, Inc.
Joseph T. Schepers, Director of Corporate Communications
678-341-1401
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