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news.GlaxoSmithKline has entered into an agreement to co-develop an over-the-counter gel for the treatment of erectile dysfunction currently being developed by Futura Medical, a UK pharmaceutical company focused on sexual health.
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If successful, the drug, currently known as MED2002, would be the world’s first non-prescription pharmaceutical treatment for men with erectile dysfunction (ED).
Under the terms of the agreement, GSK will pay 65% of the clinical development program costs for the drug and Futura will pay the remaining 35%.
The program, to be run and managed primarily by GSK, is expected to comprise up to three studies involving approximately 1,500 men with ED and several additional safety studies to support the existing studies already completed by Futura.
The agreement also includes license terms that are not yet legally binding, under which GSK would have global distribution and marketing rights for MED2002 as well as first refusal on two other products currently in the early stages of development: a non-prescription treatment for arousal and desire disorders associated with female sexual dysfunction and a non-prescription treatment for premature ejaculation.
According to data cited by Futura, it is expected that the number of men with ED will double from its current level of 152 million worldwide to 322 million by 2025 due to ageing populations.
“This is a very exciting new business opportunity for GSK Consumer Healthcare, one that meets a significant unmet need in the marketplace, and the prospect to be the first regulatory approved non-prescription erectile dysfunction product is compelling,” said Paul Berman, VP of business development and strategic planning at GSK Consumer Healthcare Europe.