The Metered Dose Transdermal Spray (MDTS) patent has been awarded to Acrux Ltd, which licensed the technology to VIVUS earlier this year.
VIVUS first tapped the marketplace with an intraurethrally-delivered drug for erectile dysfunction called MUSE (alprostadil). This concept, while compelling when the prevailing products on the market were injectables, was hit hard by competition from oral treatments such as Viagra (sildenafil) from Pfizer. MUSE is still on the US market, but VIVUS is exploring the use of other delivery technologies to treat sexual health and hormonal disorders.
The new patent, entitled Dermal Penetration Enhancers and Drug Delivery Systems Involving Same, extends the intellectual property around the MDTS, and triggers a milestone payment of $250,000 from VIVUS to Acrux.
The claims of the patent (No 6,818,226) relate to a pharmaceutical formulation for application to the skin or mucosal tissue. The formulation contains a physiologically active agent, a penetration enhancer, and a volatile liquid, with the enhancer and volatile liquid chosen so that the formulation dries within three minutes of application and the enhancer serves to transport the active agent across the body surface during and/or after drying. The patent also claims a method for administering a physiologically active agent to a patient as well as a product for administering the formulation as a spray composition.
"This … provides important long-term protection for our testosterone and oestradiol spray delivery systems," said VIVUS chief executive Leland Wilson.
MDTS - which takes the form of a handheld spray applicator - sits at the heart of VIVUS' female sexual health product platform, and the oestradiol version of the system is due to start Phase III trials later this year for the alleviation of menopausal symptoms. These are treated at present using a range of delivery formats, including oral tablets, rub-on gels and injectable implants.
Meanwhile, Phase II study results on testosterone delivered by MDTS, for the treatment of sexual desire disorder, are due in the first quarter of 2005.