New drug Zertane-ED on the horizon to treat both ED and PE in men
6th July 2012
Erectile dysfunction is one of the most frustrating conditions for a male to suffer from and it is estimated that 4 in 10 men have impotence problems. The inability to achieve and sustain an erection can cause distress for both partners and result in a dramatic loss of self-esteem for the man especially. Viagra, Cialis and Levitra remain the three most effective medications for this condition and have spawned countless illegal copies such as ‘Kamagra’. Premature ejaculation is a condition many men have long wondered how to prevent and many are still too embarrassed or afraid to seek help. Certain things to do during foreplay and even some breathing exercises may help to some degree, but effective treatments available to combat the problem remain as the prescription medication Priligy and the over the counter stud 100 spray. With all this in mind, some companies have long wondered how to conjure up something that can treat both conditions, so far without success. In June we were the bearers of good news to the thousands of men across the country who unfortunately suffer with premature ejaculation. Dr Mike Wyllie, who was a member of the Viagra team who helped to develop the product, is currently formulating a new spray to help premature ejaculation and it will be called ‘Tempe’. However, the release date of this spray is still yet to be confirmed. It has now emerged that yet another product for male premature ejaculation may be entering the market in the future. That is not all though – the drug also treats erectile dysfunction too according to its creators. The Food and Drug Administration (FDA) have given the go-ahead to Ampio Pharmaceuticals Inc to begin two clinical trials of the oral medical Zertane-ED.  The FDA have given their approval after acknowledging premature ejaculation as a disease condition with negative consequences for the sufferer such as emotional distress, frustration and sometimes the complete avoidance of sexual intimacy. This contradicts earlier reports where some suggested that the FDA did not see premature ejaculation as a treatable ailment. Michael Macaluso, Ampio's CEO, was clearly overjoyed with the FDAs ruling and said, “The clear clinical path for Zertane provided by the FDA, and the reasonable costs to complete these PE trials, allows Ampio to present potential distribution partners a portfolio of sexual dysfunction drugs that treat both PE and the PE/ED combination worldwide. Ampio was recently awarded multiple patents worldwide for combinations of Zertane with any PDE5 inhibitors and for reduction of side effects of Tramadol. These recently awarded patents will benefit from a full patent life and are important for negotiations with potential partners whose PDE5 inhibitors patent protection has expired or are about to expire, which could be greatly extended by Ampio's patents.” Ampio has now entered into a contract with the Indian-based contract research and manufacturing organisation ‘Syngene’, to manufacturer the drug. Macaluso spoke on the partnership, “As a first step for the clinical study of Zertane-ED, Ampio entered into an agreement with Syngene to begin manufacturing the combo product for the conduct of a phase III trial for these co-morbid conditions in South Korea by our partner Daewoong Co. Ltd. By previous contractual agreement Daewoong will finance and conduct the South Korean phase III trial according to US FDA standards/guidelines and the data generated will be used both for approval in South Korea and to support a US FDA submission. This agreement with Syngene will accelerate the initiation of the phase III trial in South Korea.” The release of Ampio’s Zertane-ED could be a long way off. The medication is only just entering the clinical trial stage, so it is a possibility the company may yet see some unforeseen adverse drugs of the drug and then have to further develop its active ingredients. The same applies for the premature ejaculation spray tempe, mentioned earlier.  If you are suffering from either erectile dysfunction or premature ejaculation why not try one of the many proven treatments already available NOW. Our doctors can prescribe Priligy for premature ejaculation, following a consultation. This is an oral tablet for suitable males suffering from premature ejaculation. These tablets are taken prior to the sexual activity. It acts quickly within 60 minutes and is only taken when you need it. In addition, we offer Stud 100 spray, obtainable from our chemist shop. Stud 100 delays ejaculation by reducing the sensitivity of the penis, significantly prolonging intercourse and providing greater satisfaction for both partners. We have more information on male impotence here and the variety of options that are available to best suit your needs such as Viagra, Cialis and Levitra. We are at the forefront of new treatments for impotence and will be one of the first online pharmacies to offer Viagra Chewable (aka Viagra Jet) to patients as soon as it hits these shores, so keep checking the website for updates!