Fortacin USA Availability – PSD502 FDA Approval Process
There is a lot of anticipation about the introduction of Fortacin in the USA. The product has positive FDA clinical trial data and has been introduced in many other countries around the world. So I did some googling and found an April 2017 presentation from the new owner of the product, Regent Pacific Group, which claims that Fortacin is projected to through with the FDA approval process by the end of 2019 and will be available for sale in 2020.
I was able to obtain some of the product (it’s currently for sale in other countries) and I found it a high-quality product and I put it in the same class as Promescent and much better than other desensitizing sprays and creams. Here’s my evaluation of the best premature ejaculation sprays.
UPDATE: In 2021, Fortacin will undergo clinical trials in China so even more information about its safety and effectiveness will available down the line. And a phase III trial was due to happen in 2021 in the USA, with a view to gaining FDA approval in the future presumably.
Fortacin™ is the first topical treatment to be offcially approved for the treatment of primary PE in adult men, and is mentioned as an experimental aerosol (as TEMPE) in the current European Association of Urology guidelines. It was approved for use in the European Union and launched in the United Kingdom in November 2016. Fortacin™ is a eutectic-like mixture of lidocaine 150 mg/mL and prilocaine 50 mg/mL that meets the requirements of an ideal treatment for PE because it is fast acng (within 5 minutes), has durable effects, can be easily used “on-demand”, and shows minimal side-effects. The metered-dose spray delivery system allows the desensitizing agents to be deposited in a dose-controlled, concentrated film onto the glans penis consequently reducing its sensivity. This is translated into a delaying of the ejaculatory latency time without adversely affecting the sensation of ejaculation and orgasmic pleasure. The efficacy and safety of Forta-cin™ have been proven by means of increased ejaculatory latency, control, and sexual satisfaction in large scale studies demonstrating the significant benefits for both patients and their partners.
Fortacin™, Intravaginal ejaculatory latency time, Lidocaine/Prilocaine, Premature ejaculation, Topical anesthesia
