Sciele Pharma, Inc. (“Sciele”)
(NASDAQ:SCRX), a specialty pharmaceutical company, today announced that
Plethora Solutions Holdings PLC (“Plethora”)
(AIM:PLE), the specialist developer of products for the treatment and
management of urological disorders, has completed its European Phase III
study of PSD502 for the treatment of premature ejaculation (PE) in
Europe. The study was initiated in December 2007 and these results from
the blinded study are expected in the fourth quarter of 2008.
In recently published results from a Phase II study, PSD502 was shown to
increase ejaculation latency time significantly when compared with
placebo (Dinsmore W et al BJU Int 2007; 99: 369-35).
There are two pivotal PSD502 studies running in parallel, one in North
America and one in Europe. Each is a multi-centre, randomized, double
blind, placebo-controlled efficacy study recruiting a total of 540
patients across both studies. 275 patients will have completed the
blinded phase of the study across 32 investigational centers in 4
countries across Europe. Of these, 265 patients have entered an optional
5 month open-label study.
Recruitment in the equivalent study in the U.S. is ongoing and data from
the two studies will be combined for submission for regulatory approval
in the U.S. and Europe. A new drug application (NDA) for PSD502 is
expected to be submitted to the FDA in the first half of 2009.
In May 2007, Sciele signed an exclusive licensing agreement with
Plethora Solutions to market PSD502 in the U.S.
Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, “We
are pleased with the progress Plethora has made with the development of
PSD502, which addresses an unmet medical need that affects a significant
number of adult males in all age groups.”
Dr. Mike Wyllie, CSO of Plethora, commented, “We
are delighted to have completed this arm of the Phase III study. The
willingness of patients to enter the open-label study is most
encouraging as is the low dropout rate throughout the trial. The speed
at which recruitment was completed, given the stringent entry criteria,
confirms both the number of PE patients in the general population and
their willingness to seek treatment.”
About Sciele Pharma, Inc.
Sciele Pharma, Inc. 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.
