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History of Priligy

Priligy (dapoxetine hydrochloride) is the first oral medication to be approved for the treatment of premature ejaculation (PE). The initial development of dapoxetine 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 Paxil and Zoloft, dapoxetine is a selective serotonin reuptake inhibitor (SSRI). In fact, following the drug's early development over a decade ago, Eli Lilly began phase I clinical trials for priligy as an antidepressant medication. Dapoxetine didn't pan out as an antidepressant, and was shelved for a while. But the same thing that caused its failure as a psychopharmaceutical turned out to be the reason for its success as a treatment for premature ejaculation.

Sometimes Quicker Is Better

Like other SSRIs, Priligy has the effect of delaying orgasm and ejaculation, and for some time doctors have been prescribing other SSRIs to treat premature ejaculation. However, since these antidepressants are not approved by the FDA for treating this condition, this is considered "off label" use. Unlike other SSRIs, dapoxetine is absorbed and eliminated by the body very quickly - within a matter of a few hours, rather than days. It was Eli Lilly researcher Karl Thor who reportedly first realized the drug's potential as a treatment specifically for premature ejaculation. Its short residence in the body made it unviable as an antidepressant, but makes it suitable for treating PE "on demand" or only when needed. Eli Lilly resumed trials with the drug, this time as a treatment for premature ejaculation.

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Who Owns Dapoxetine?

The rights and patents for the drug have changed hands a few times, and several pharmaceutical companies have their fingers in the dapoxetine pie. The drug was originated by Eli Lilly, but in 1998, PPD GenuPro acquired the rights and from Eli Lilly to develop the drug as a premature ejaculation treatment. In 2001, PPD sold exclusive worldwide marketing and development rights for dapoxetine to ALZA Corporation, which is an affiliate of Johnson & Johnson. In 2003, PPD bought the patents for dapoxetine from Eli Lilly. ALZA is the current license holder, but PPD will still get milestone payments and drug royalties from ALZA, and Eli Lilly may receive royalties from PPD if they exceed a certain amount. Dapoxetine will be marketed in the US by Ortho McNeil, by Janssen-Ortho Inc. in Canada, and is currently being marketed in Europe by Janssen-Cilag; these are all units of Johnson & Johnson.

Seeking Approval

Initial clinical trials of dapoxetine (phase I) for FDA approval were carried out by Eli Lilly, followed by phase II trials in collaboration with PPD GenuPro. PPD continued phase III trials, and presented the findings of two major trials in 2005. Among men aged 18-65 given doses of 60mg or 100mg of dapoxetine, length of time to ejaculation increased from under a minute to 2-3 minutes in a significant number. As of 2008, dapoxetine had been tested in five major phase III trials with over 6,000 subjects total, and was found to increase intravaginal ejaculatory latency time (time till ejaculation during intercourse) as well as users' sense of control over ejaculation and overall sexual satisfaction.

Despite its success in clinical trials, dapoxetine has still not been approved by the FDA. In December 2004, ALZA submitted a new drug application to the FDA for dapoxetine hydrochloride. Ten months later, the FDA responded by issuing a "not approvable" letter for the drug. Nevertheless, development of the drug continued and Johnson & Johnson initiated additional clinical trials to address the drug's possible risks and side effects, while pursuing approval outside of the US. In July 2007, Janssen-Cilag submitted an application to market the drug in Europe for the treatment of PE, beginning in Sweden. The process was finalized in December 2008, and in February 2009 it was announced that Sweden and Finland had approved marketing of dapoxetine, with authorization from Austria, Germany, Spain, Italy and Portugal expected to follow shortly.

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