FLD500 (the Female Lubrication Device) will be a sister product to CSD500. Unlike CSD500, the active compound will be applied to the outside of a condom thereby coming into direct contact with the vagina during sexual intercourse.
The active compound will encourage natural lubrication during intercourse. FLD500 is aimed at helping healthy women maintain natural lubrication during intercourse, reducing the risk of discomfort and condom failure.
During sexual intercourse a pharmacological dose of the active molecule will be delivered to the clitoral and peri-clitoral regions. This will result in improved local blood flow which in turn will enhance natural vaginal lubrication. The product will reduce the risk of condom slippage during intercourse. As well as improving safety, this is expected to facilitate an enhanced overall sexual experience for both partners although this is still being clinically tested.
The product is expected to be classified within the EU as a Class III medical device with an ancillary medicinal substance.
Futura has completed a Proof of Concept study. The active compound was applied to trial subjects and was found to be safe and well tolerated at the lower-strength doses, with no adverse events experienced during the exposures.
The response was measured using a technique that monitors the blood flow in the vaginal tissue. In simple terms the results showed increased blood flow in the vaginal tissue. This pattern of changes observed mimics the blood flow changes seen in women during clitoral stimulation and sexual arousal.
FLD500 uses a much lower dose of the active compound used in CSD500. This presents greater challenges in developing a product with a commercially acceptable shelf life for the product. We have developed a new prototype of the product which will simplify the manufacturing process and so far in pilot stability studies this has shown a significantly improved shelf life. We are determining the marketing and regulatory strategy for the product with SSL prior to initialising formal stability studies.
In July 2005, SSL International plc, the consumer healthcare brands company and manufacturer and distributor of Durex®, the world's biggest-selling branded condom, exercised its option for the global marketing and distribution rights for FLD500.
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