"Dapoxetine' says Dr Pryor, the chief investigator who conducted the trial, "improved patient's perceptions of control over ejaculation, satisfaction with sexual intercourse, and overall impression of change in their condition. Partners benefited through improved satisfaction with sexual intercourse ...

 

 

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Dapoxetine and the FDA.

 

The FDA and Dapoxetine - Will it ever be approved?

Dapoxetine has been submitted for FDA approval and been denied on more than one occasion. Dapoxetine (INN, brand name Priligy) is a short-acting SSRI drug for the treatment of premature ejaculation in men. Dapoxetine is the only drug with regulatory approval for such treatment. Currently, it is approved for use in a handful of European countries including Finland, Sweden, Portugal, Austria and Germany. Dapoxetine is also being considered for approval in other European countries and in the United States where it is currently in Phase III of the Food and Drug Administration (FDA) approval process.

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On December 28, 2004, dapoxetine was submitted to the FDA in the form of dapoxetine hydrochloride by the ALZA Corporation and its parent company, Johnson & Johnson, for the treatment of premature ejaculation with a New Drug Application.

 

In October 2005, the FDA issued a "not approvable" letter for dapoxetine, delaying approval in the United States. Despite two further clinical trials completed in 2006, it has yet to be approved by the FDA.

 

Dapoxetine was submitted for approval in Europe and is now being reviewed. In Feb 2009, it has first received approval in Sweden & Finland. Later, in Austria, Portugal and recently in Germany and Italy. Approvals for Dapoxetine are also anticipated in other European countries as well. Filings for approval have been submitted in Canada, Australia, Mexico, Turkey and six other countries.

 

The reasons for the FDA denial of the Dapoxetine (Priligy) application are not known at this time. It is suspected that the delay in approval is related to the safety and possible side effects of Dapoxetine. Some possible side-effects of dapoxetine include dizziness, nausea, insomnia, headache and diarrhea. The other main concern is that since Dapoxetine is a very new drug, the long term safety of Dapoxetine on humans has not yet been thoroughly documented.


 

Dapoxetine - Phase III trials.

What are the different phases involved in a drug getting approved and what are "Phase III" trials? Clinical Dapoxetine trials and any trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. The drug-development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV are 'post-approval' studies. Before pharmaceutical companies start clinical trials on a drug, they conduct extensive pre-clinical studies.

 

Phase III studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming, and difficult trials to design and run, especially in therapies for chronic medical conditions.

 

It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorized as "Phase IIIB studies."

 

While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), TGA (Australia) or EMEA (European Union), for example.

 

Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities in different countries. They will review the submission, and it is hoped, give the sponsor approval to market the drug.

 

 


 

Dapoxetine Approval - How long could it take?

How close is Dapoxetine to being approved for sale in the United States? This is not clear at the present time. Currently Dapoxetine is undergoing Phase III trials in the US as the last step before re-submitting Dapoxetine for FDA approval. Should Dapoxetine eventually get FDA approval, it will be marketed under the brand name Priligy, as it already is in the 6 European countries where it's available.

curing-premature-ejaculation

It is possible that Dapoxetine will not be available in the United States or elsewhere for a few years. There is also a possibility that Dapxoetine may never be approved for sale in the US, Canada, the UK, and other countries. It mainly depends if the governing bodies in these countries find that the benefits of Dapoxetine outweigh the side effects and potential health risks.

 

While Dapoxetine (Priligy) may get FDA approval in the next few years, there is also a chance it could take longer - or not happen at all. The good news is that even so, there is no reason for men to suffer needlessly from the damaging effects of premature ejaculation. There are medically approved treatments for premature ejaculation available now which have enjoyed outstanding success. Not only are these products natural and very effective, they are extremely safe.

 

Top rated premature ejaculation treatments like Prexil and VigRX Plus have enjoyed success rates as high as 92%. Due to this extremely high success rate, these companies are able to offer 100% money back guarantees if you are one of the few men who don't get these astounding results. This means you can try these products at home completely risk free - and find out first-hand how these PE treatments will help you last significantly longer during sex.

 

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