A nifty spray-on solution could make all the difference for men plagued with the problem of climaxing too soon, as the product makes its final thrust in clinical development.
Plethora Solutions has developed the handy spray-on product, which will presumably arouse much interest from the 30 per cent of the male population thought to suffer from premature ejaculation (PE).
While erectile dysfunction has garnered much publicity thanks to the likes of high profile treatments such as Pfizer's Viagra (sildenafil citrate), PE has had to make do as the neglected younger brother, with no products currently approved to treat the problem.
The only options available to PE patients today are off-label use of products such as antidepressants (with all the associated side effects) or penile desensitisers, with topically applied options carrying the impracticalities of slow onset of action, messiness or loss of sensation altogether.
Plethora, however, believes it could have the first product on the market that is quick, user-friendly, and can increase the time between penetration and ejaculation four fold.
The product is a combination of well-known anaesthetics lidocaine (7.5mg) and prilocaine (2.5mg) which together form a eutectic mixture (i.e. the melting point of the mixture is lower than the two components separately).
However, Plethora discovered that this mixture dissolves easily in a non-CFC propellant, creating the possibility of a spray-on product that delivers pure active drug.
The formulation is only absorbed by non-keratinised skin (i.e. open or broken skin), and therefore only penetrates the glans at the tip of the penis and not the shaft.
One of the key advantages over other products that PE patients currently have to use is that Plethora's PSD502 formulation kicks in in under five minutes - much quicker than other products that can take over half an hour to take effect, or off-label use of anti-depressants that need to be taken for several months before any result can be seen.
On top of this, the effects of the spray-on treatment last for at least two hours, with the topical application meaning no systemic absorption to cause safety issues, and the rapid drying time of just a few minutes means the product will not get transferred to partners.
But most importantly, the Plethora formulation has been shown to increase the time from penetration to ejaculation within the vagina by four times - from 0.93 minutes in a placebo group to 3.7 minutes with the spray-on solution.
While this might not sound like a vast improvement, for the significant proportion of the male population who have difficulty controlling ejaculation or lasting more than a minute or so, it could be the first product approved specifically for the condition that makes real difference to their sexual performance.
The product should cost no more than the options currently being prescribed by physicians, and will come with a two to four month supply of treatment (depending on how often it's used).
Plethora announced the initiation of Phase III trials of the product yesterday, with pivotal studies expected to take no more than 12-15 months, and product launch anticipated towards the end of 2009 - just in time for Christmas.
"Premature ejaculation is much more prevalent than erectile dysfunction," Plethora's chief business officer Sandrine Cailleteau pointed out to in-PharmaTechnologist.com.
"With no approved treatment available, we hope to have the first product approved for this indication…it has the potential to be front line therapy."
The potential revenues for the product could therefore be enormous; with the erectile dysfunction market currently raking in around $3bn (€2.1bn) a year (half coming from Viagra), and the premature ejaculation market significantly larger, Plethora could be looking at some serious cash coming from its spray-on treatment.
In addition to the PE market, Plethora is also looking at the use of the PSD502 formulation in pain management, and has already reported promising results from early studies in burns patients receiving skin grafts.