Priligy (dapoxetine hydrochloride) is the first oral medication to be approved for the treatment of premature ejaculation. It was by chance that they discovered its ability to treat premature ejaculation, actually developed to treat depression. In this electronic resource (e-source), we’ll use the Viagra™ story to show how a medicine is designed, developed and produced As an active ingredient in Priligy, dapoxetine hydrochloride belongs to the class of medicines called selective serotonin reuptake inhibitors (SSRIs) with a short half-life of 1 or 2 hours, it is considered safe and sound for the treatment of premature ejaculation. At the initial development of dapoxetine, it has been credited by some sources to Eli Lilly chemist David Wong, who was also one of the developers of fluoxetine (Prozac). Like Prozac and other antidepressants such as Zoloft, Escitalopram and Paxil, dapoxetine is SSRI. In fact, considering the drug’s early development over a decade ago, Eli Lilly began phase I clinical trials for dapoxetine as an antidepressant medication. But dapoxetine was put on hold for a while and didn’t pan out as an antidepressant. But the same thing that leads to its failure as a psychopharmaceutical turned out to be the cause for its success as a premature ejaculation treatment.
Dapoxetine as a SRRI
Similar to other SSRIs, dapoxetine has the effect of delaying ejaculation and orgasm, and for a while doctors have been prescribing other SSRIs to treat premature ejaculation. But, as these antidepressants for treating this condition are not approved by the FDA, this is considered for “off label” use. As unlike other SSRIs, dapoxetine is easily and rapidly absorbed and eliminated by the body i.e. within few hours, rather than days. It was Karl Thor an Eli Lilly researcher who realized the drug’s potential as a treatment particularly for premature ejaculation. Due to its short residence in the body, it is considered unfeasible as an antidepressant. But on the other hand makes it more suitable for treating premature ejaculation. Eli Lilly resumed several trials with the remedy, but this time as a treatment for premature ejaculation.
Who Owns Priligy dapoxetine?
The patents and rights for the remedy have changed sometimes, and a number of pharmaceutical companies have owned the rights to dapoxetine. The drug was originated by Eli Lilly, but in 1998, to develop the drug as a premature ejaculation treatment, PPD GenuPro acquired the rights from Eli Lilly. But in 2001, PPD sold exclusive worldwide marketing and development rights for dapoxetine to an affiliate of Johnson & Johnson, ALZA Corporation. In 2003, PPD bought the patents for dapoxetine from Eli Lilly. PPD will still get milestone payments and drug royalties from ALZA, even if ALZA is the current license holder. However, if PPD exceed a certain amount Eli Lilly may possibly receive royalties from it. Now-a-days dapoxetine will be marketed in Canada by Janssen-Ortho Inc., in US by Ortho McNeil, and is currently being marketed in Europe by Janssen-Cilag; all are units of Johnson & Johnson.
Why Priligy (dapoxetine) is a safe drug?
Eli Lilly carried out the initial clinical trials of dapoxetine (phase I) for FDA approval. In collaboration with PPD GenuPro the phase II trials is executed. PPD presented the findings of two major trials in 2005 after continuing with phase III trials. Doses of 60mg or 100mg of dapoxetine were given to the men having age between 18 and 65 resulting in improved length of time to ejaculate. In 2008, dapoxetine had been tested with over 6,000 subjects in five major phase III trials. It was found that dapoxetine was not only increasing the intravaginal ejaculatory latency time but also improves overall sexual satisfaction and the sense of control over ejaculation.
It has been submitted for approval in the European Union and is being reviewed. In 2009, it’s been approved in Sweden, Finland, Austria, Portugal, Germany, Italy and Spain. And approvals are also anticipated in other European countries as well. In addition to this, in Canada, Australia, Mexico, Turkey and six other countries the submissions for approval have been done.