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.
It is announced that dapoxetine is going to go ahead with phase three investigations for the treatment of premature ejaculation.
PPD, Inc. announced that today it would be acquiring from Eli Lilly the rights for the compound dapoxetine. PPD will pay Lilly $65 million dollars for this accusition as well as pay a percentage of any profits made. Previously it was made known that PPD had in-licensed dapoxetine back in 1998 from Lilly, developed it, then licensed it out to ALZA Corp (owned subsidiary of Johnson and Johnson) back in 2001. PPD and Lilly have ended their old licensed agreement regarding this substance. Currently dapoxetine is in phase three testing for premature ejaculation.
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.
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.
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.
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.
Dapoxetine Denied by the FDA
ALZA Corporation announced today that it has received a “disapprove” letter from the U.S. Food and Drug Administration on their New Drug Application for dapoxetine hydrochloride, a trial drug used to treat premature ejaculation (PE). ALZA however plans to address questions that where raised in the letter they received and still plans on developing this medication for PE.
Dapoxetine Deemed Safe And Effective In Treating Premature Ejaculation. Researchers at the University of Minnesota stated that after research on 2,600 men they deemed that Dapoxetine increased the duration of intercourse from less than a minute to three minutes and 19 seconds.
Johnson & Johnson is getting ready to file dapoxetine in Europe and Canada later this year for a treatement for premature ejaculation. This selective serotonin uptake inhibitor has shown excellent promise in being the first medication to treat PE. It has also not dismissed submitting it again to the FDA for approval in the US.
Janssen-Cilag (a part of Johnson & Johnson) has submitted a Marketing Authorisation Application (MAA) for dapoxetine for the treatment of PE in men between the ages of 18 to 64. Sweden will act as the Reference Member State. Finland, Italy, Austria, Germany, Spain and Portugal will act as Concerned Member States regarding the application. It is there intention to have regulatory submissions take place in other parts of the world soon.
Priligy™ (generic Dapoxetine) receives approval for Premature Ejaculation in Sweden and Finland. Janssen-Cilag (a division of Janssen Pharmaceutica N. V.), announced that Priligy™ (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 years of age. This comes as a result of positive outcome of seven European Union countries consisting of Austria, Germany, Spain, Portugal, Italy, Sweden and Finland. Sweden and Finland are the first nations to allow dapoxetine as a prescription treatment for premature ejaculation. It is expected that the other five countries mentioned will soon allow licenses for this treatment. At this time it is not approved for marketing in the US.
Janssen-Ortho Inc, filed an application with Health Canada to market Priligy in Canada.
Priligy is now available in Germany. J&J also seeks to sell the pill in Australia, Mexico, Turkey and six other countries
Janssen Korea has been given the go ahead to start selling Priligy. This marks the first approval of Priligy in Asia.
Priligy® has now been approved for Premature Ejaculation in New Zealand for men between the ages of 18 to 64. It is estimated that as many as 250,000 men in New Zealand suffer from this problem.
USA-based Furiex Pharmaceuticals was transferred the worldwide rights for Priligy from ALZA Corp and Janssen Pharmaceutica (both part of the Johnson & Johnson group). At the same time, Furiex entered an agreement with Italian drugmaker Menarini, for rights to commercialize Priligy in Europe, most of Asia, Africa, Latin America and the Middle East. Furiex retains full development and commercialization rights in the USA, Japan and Canada.
Furiex was scheduled to receive $15 million on closing, up to $20 million in regulatory and launch milestones and up to $40 million in sales-based milestones, plus tiered royalties on product sales ranging from mid-teens to mid-twenties in percentage terms. Menarini will assume responsibility for commercialization activities in the licensed territories and will fund on-going clinical trials.
FDA Approval of Dapoxetine / Priligy
Despite approval in other countries, Dapoxetine has not achieved FDA approval for distribution in the United States.