Here are some note worthy news pieces showing the general development of Priligy® / Dapoxetine. It is not our intention to follow every single news story that ever mentions this drug, but rather give an indication of a time line from its early beginnings of what has happened with Priligy® / Dapoxetine to what is happening today with its development. Please note these news pieces are pharaphrased and maybe brief in content in order to provide a quick overview. January 5th, 2004 PPD, Inc. has come into an amendment to the dapoxetine license agreement with ALZA Corp (company of Johnson & Johnson). Unter the agreement, some sales based payments will be stopped for a time after the New Drug Application approval to a certain amount. As part of the deal, ALZA will make a payment to PPD and have agreed to have the amount a fixed payment to be paid to PPD upon the NDA approval. July 4th, 2004 It was annouced today that Johnson & Johnson plans on submitting to the FDA (Food and Drug Administration) next year (2005) the approval of the pill dapoxetine to be used for premature ejaculation. October 20th, 2004 According to clinical testing results of a phase 2, placebo controlled, double blind, multicenter and randomized tests, Dapoxetine is considered to be well tolerated and helps premature ejaculation. This information was presented at the 11th World Congress of the International Society for Sexual and Impotence Research in Buenos Aires, Argentina. To show its effectiveness, 166 men between the ages of 23 to 64 with a lasting time less than two minutes where put into a group that received either 60mg, 100mg or the placebo. And where given 3 days inbetween treatments to allow a full flushing of the system of any reminant effects from the drug. Each male was in a monogamous relationship lasting for at least a six month period. Of the 166, 130 men ended up completing the study. One of the men dropping out was from the placebo group and the other 9 where from the 100mg group, due mostly to nausea. There where no 60mg members that quit the testing. The results where impressive, the 60mg group lasted 2.94 minutes where as the 100mg group lasted 3.2 minutes. The placebo group a mere 2.05 minutes. Dec 28th, 2004 Dapoxetine was Submitted to the FDA for Premature Ejaculation ALZA Corporation announced that it has submitted Dapoxetine hydrochloride to the U.S. Food and Drug Administration for the treatment of premature ejaculation (PE). Further stating that PE is the most common male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives. |
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Priligy® / Dapoxetine Information |
