The study was designed to confirm an earlier proof of concept study. It is a ‘gold standard’ double-blind, placebo-controlled, multiple-dose crossover study comparing the efficacy of intra-vaginally delivered PSD508 to that of oral non-steroidal anti-inflammatory drugs (NSAID) and placebo in relieving menstrual-associated pain.
This study is taking place across three consecutive menstrual cycles, allowing the trial to be completed in the shortest possible time frame. The study will also add to the extensive existing clinical data on the safety and tolerability of PSD508. A total of 159 patients have been enrolled into the study at three centres in the UK.
PSD508 is a proprietary delivery form of a well characterised NSAID, which is administered intra-vaginally utilising technology which Plethora licensed from Metris Therapeutics in 2006. This novel approach has the potential benefit of allowing women to access a convenient ‘on-demand’ treatment containing an NSAID while minimising systemic exposure to the drug and thereby lowering the risk of side effects which limit the usefulness of existing therapies.
Mike Wyllie, chief scientific oficer of Plethora, said: “The conclusion of this study, when the outcome is reported in full later this year, will also end our period of significant investment in Phase II studies in our women’s health portfolio. These include PSD503 for the treatment of stress urinary incontinence, PSD506 for overactive bladder and PSD597 for the treatment of interstitial cystitis; all of which are now the subject of early stage licensing discussions.”