Apricus Biosciences, Inc, a specialty pharmaceutical company, reported that the Israeli Patent Office recently issued a Notice of Allowance to grant a patent for the company's development of a topical cream utilizing vasoactive prostaglandin E to treat premature ejaculation (PE).
When issued, the patent, entitled, “Compositions and Methods for the Treatment of Premature Ejaculation,” will provide Israeli patent protection until March 2024. It is one in a series of issued patents and pending applications that Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary NexACT technology, which includes its Vitaros product to treat erectile dysfunction (ED), among others in research and development.
Commenting on news, Dr Bassam Damaj, chairman, president and CEO of Apricus Bio, stated, “We are very pleased with the allowance of this patent in Israel for the use of vasoactive prostaglandin E to treat PE. This patent includes the same pharmaceutical composition as found in Apricus Bio's Vitaros product for ED combined with a local anaesthetic and represents our tenth patent granted in that country on our NexACT technology. Our proprietary NexACT technology has enabled the Company to pursue and enter into partnerships for the development and commercialization of Vitaros and other NexACT products. We look forward to expanding our PE patent portfolio and to speaking with potential partners regarding the development and commercialization of pharmaceutical products for the treatment of PE in key countries throughout the world.”
Vitaros has been approved by Health Canada for marketing and sales for patients with ED and the Company has filed for marketing approval for the drug for this indication in the European Union and Switzerland. Vitaros is a topical cream that incorporates alprostadil, a well-recognized vasodilator currently marketed by other companies as an injectable product or an intra-urethral insert. The drug has been studied in over 3,300 patients, including difficult to treat populations, such as those with diabetes, cardiac problems, sildenafil (Viagra) failures and post prostatectomy patients. Vitaros has demonstrated clinical efficacy and an excellent safety profile versus the currently approved oral therapies, and is not contraindicated for patients taking alpha blockers or nitrate medication. Viagra is a registered trademark of Pfizer, Inc.
Apricus Bio is currently studying the use of vasoactive prostaglandin E, combined with and without local anaesthetics, to develop a topical cream to treat PE. To date, the Company has completed three clinical studies for this application, including two single-blind studies and one double-blind study.
The company's PE patent portfolio currently consists of five issued patents (Australia, Singapore, Japan, Korea and soon-to-be Israel) and seven pending applications (the U.S., Canada, Europe, Mexico, Brazil, China and Hong Kong).
According to Datamonitor 2010, “Premature ejaculation is a commonly yet poorly understood and defined male condition. Prevalence estimates vary greatly from 4% to 29% as stated by a study done by Simons and Carey (2001), according to the different definitions used. The disorder is currently severely undertreated and off-label prescription of selective serontonin reuptake inhibitors ("SSRIs") is the most common treatment pathway in the seven major markets.”