Are we going to witness the end of Viagra, the so-called wonder pill that has helped millions of men with Erectile Dysfunction (ED)? Since it was approved in 1998, Pfizer, the Viagra manufacturer, earned billions. It is one of the fastest selling ED drugs in history.
However, its patent will soon expire in 2020. In fact, innumerable generic versions of Viagra have emerged in the past few years, often in a variety of forms such as oral jellies, chewable tablets, soft tablets, sublingual tablets, and even effervescent pills. Soon, these will be flooding the market, as generic drug manufacturers are leaving no stone unturned when it comes to entering the ED market.
Generic versions will make Viagra more accessible and affordable. This, for the millions of men worldwide with ED, could spell good news in the form of much-needed ED treatment without burning a hole in their pocket. After Viagra, the FDA approved similar drugs such as Levitra and Cialis, which also work just like Viagra.
Dr. Samit Soni, a urologist at the Baylor College of Medicine in Houston, Texas, said, “There’s a huge need for new treatments which work in the widest patient population possible while having a longer-acting effect to improve spontaneity and reduce the stress of having to take them on a planned basis. Many patients would like to be able to take something and then not have to worry about it for 30 days.”
However, at the moment, there are very few options. The only FDA-approved Viagra alternatives available are penile implants and vacuum devices, which are invasive and painful.
Dr. Soni said, “For many years after Viagra was developed, little changed in our understanding of erectile dysfunction and how to correct it. But with the patent expiration, there’s definitely a renewed interest in alternative pathways for treating erectile dysfunction, and using them to develop new ideas that can be patented, and provide a sustainable profit to the industry.”
Viagra 2.0 Version
Scientists at Futura Medical, a Surry pharmaceutical company, came across studies of a heart disease medicine that accidentally helped induce erections in the early 2000s.
Head of research and development at Futura Medical Ken James said, “There were some anecdotal reports of people deliberately spraying this product on to their penises. These observations had been reported in the scientific literature, and the company thought there might be a commercial opportunity.”
The scientists found that it was a molecule called Glyceryl Trinitrate (GTN) that caused the vasodilatation in the penile organ, including blood flow to cause an erection.
The researchers at Futura Medical were quite fascinated by these results because Viagra, Levitra and Cialis are oral drugs, which means they have to be taken orally to reach the bloodstream as well as other systems of the body, while GTN is rapidly absorbed into the erectile tissues via the skin. GTN can be directly applied to the skin so there is no risk of developing troublesome side effects like oral ED drugs.
James explained, “Viagra and Cialis are quite effective drugs but 50% of people stop using them within a year. 60-70% of people have some degree of dissatisfaction with them. This shows there’s an opportunity if we can come to market with something that addresses many of those concerns.”
Futura developed a GTN-based gel known as Eroxon, which has the ability to include an erection in men with mild to moderate ED within a few minutes of local application.
The company successfully conducted a clinical study of 232 patients last year. It has now commenced on a final phase III clinical trial of 1,000 patients, which is expected to be completed by the end of 2019. If the company succeeds, Eroxon will be available within the next couple of years, although with some precautions.
Dr. Soni said, “The biggest question from that phase III trial will be how they compare in clinical efficacy to Viagra. In the past, we’ve seen that it’s difficult to get similar efficacy with topical administration, but at the same time, our understanding of how drugs can be absorbed through the skin into the bloodstream has massively improved.”
However, the scientists at Futura admitted that Eroxon is unlikely to help men with severe ED, typically caused by nerve damage.
Meanwhile, many researchers are in the race of developing effective and affordable Viagra alternatives. For instance, there have been many research programs and clinical trials conducted for treating ED with shockwave therapy, which included passing low-intensity sound waves through the penile tissues to induce an erection. Another experimental concept called genome editing has been undergoing trials to treat ED.
However, it is unclear how or why they work. Dr. Soni concluded, “There hasn’t been any real innovation in erectile dysfunction for many years now. These new breakthroughs and treatments are offering excitement to an area of healthcare that has really been lulled for a long time.”
