A safety & tolerability study of administration of PSD502

• Research type

  Research Study

• Full title

  A Phase I, single-centre, double-blind, randomised, placebo controlled, parallel group, pharmacokinetic and safety study to evaluate systemic exposure and local vaginal exposure to lidocaine and prilocaine and the metabolites 2,6,dimethylalanine (2,6,DMA) and o-toluidine; and the safety and tolerability of PSD502 in female healthy volunteer subjects following daily application to the vagina and cervix for seven days with three different doses of PSD502 or placebo.

• IRAS ID

  34527

• Contact name

  David J A Bell

• Sponsor organisation

  Sciele Pharma, Inc

• Eudract number

  2009-017414-68

• Research summary

  The study drug is a metered dose anaesthetic spray which is being developed for the treatment of premature ejaculation (PE). The use of anaesthetic in topical creams has been well established and there is a licensed topical anaesthetic cream already on the market with the same active ingredients as this spray (EMLA Cream 5%, lidocane & prilocane). The use of a cream does not result in the concentrated drug being in direct contact with the cells, unlike the spray.Eight clinical studies have already been carried out for this spray, two involved the recuritment of 556 PE patients with some being dosed for up to one year. These studies have demonstrated an increase the time it takes for ejaculation in a male during intercourse and no safety concerns for male patients or their female partners. The partners of clinical study participants have been asked to report health changes during the studies. Reports of vaginal numbness have not been common however, effects of the transfer to a partner cannot be excluded. This study is being conducted to determine the effects in females of the drug on the whole body's well as local vaginal exposure to the spray. This study will be conducted in order to support a marketing application in the US at the request of the FDA.

• REC name

  HSC REC A

• REC reference

  09/NIR01/69

• Date of REC Opinion

  18 Dec 2009

• REC opinion

  Further Information Favourable Opinion