Inhaler solution to premature ejaculation hasn't come too soon

By Katrina Megget

- Last updated on GMT

Related tags Clinical trial

The end of premature ejaculation is in sight as a simple inhalation
of a drug promises to prolong the action under the sheets.

UK pulmonary drug development company Vectura announced a potential breakthrough for the treatment of the strikingly common sexual dysfunction, which affects 30 per cent of men at some time in their life, after receiving successful results in its Phase IIa proof-of-concept clinical study.

By simply inhaling Vectura's product VR776, patients demonstrated a clinical effect within 15 minutes of dosing and an improvement in the time it took for ejaculation within the vagina, known as intravaginal ejaculatory latency time (IVELT).

Not only is this exciting news for the some 50 million men affected in Europe and the US who have no approved product to turn to, but the novel system by which the drug is delivered, means the drug taking does not have to occur six hours before a naughty rendezvous, which would be the case if the treatment was in pill form.

By using Vectura's Aspirair dry powder inhaler (DPI), a patent-protected single unit dose DPI, VR776 can be delivered with a high lung penetration and rapid delivery to the bloodstream.

Vectura believed the device was conveniently sized and simple to use compared to other inhalers.

The inhaler works by generating an aerosol plume, triggered by a patient's inhalation, which is slower than most spray type active inhalers currently available.

This means that the amount of powder that is unintentionally deposited in the mouth and throat is reduced.

VR776, a proprietary formulation of a centrally-acting undisclosed drug which works in the brain to delay ejaculation, is formulated using PowderHale, a patented technology optimising the delivery of dry powders.

Typically, dry powder inhaled formulations have a limited penetration to the lungs, but PowderHale delivers a consistent fine particle dose of the drug to the lung with a high penetration by modifying the interactive forces holding together the active drug particle and carrier particles.

"We are very pleased to have achieved proof of concept and demonstrated the VR766 improves IVELT," Vectura director of investor relations and corporate communications Julia Wilson told in-PharmaTechnologist.com.

Clinically, PE is defined as a persistent or recurrent ejaculation occurring sooner than desired either before or shortly after penetration, typically in less than two minutes, over which the sufferer has minimal or no control.

Current treatment is counselling and/or the use of desensitising products.

Wilson said that while the product still needed further refinement, VR776 had "a huge market potential".

Vectura chief executive Dr Chris Blackwell said: "Premature ejaculation is a common and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners.

"The initial evaluation of the results of this study endorses our belief that the potential remains for VR776 to be a rapidly-acting and effective treatment for PE patients.

We are also very pleased that the study provides further validation of the effectiveness of our Aspirair dry powder inhaler device," he said.

Vectura believed the next stage in the development of VR776 was to establish whether bigger improvements in IVELT could be achieved at higher doses to optimise the potential therapeutic benefit, and may require reformulation of the product.

Vectura is also developing VR004, an inhaled systemic product for treating erectile dysfunction.

Successful Phase IIb clinical trials have been completed and Vectura is now seeking licensing partners for the product.

Earlier today, UK-based urological disorder product development and marketing company Plethora Solutions announced it had signed an exclusive license agreement with US pharmaceutical company Sciele Pharma for the marketing of PSD502 for premature ejaculation in the US.

PSD502 comprises a unique, proprietary, and rapidly absorbed formulation of two well-established anaesthetics, lidocaine and prilocaine, dispensed in a metered-dose spray.

Plethora has completed a Phase II clinical trial using PSD502, and Plethora is expected to begin a Phase III study in the second half of 2007.

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