Premature ejaculation pill Priligy (dapoxetine) to seek US FDA approval soon

Priligy (dapoxetine) is the first-ever oral pill approved to treat premature ejaculation

Priligy, a drug approved in several European countries to treat premature ejaculation, has completed  additional studies to confirm its efficacy and safety for a US FDA review.

Priligy contains dapoxetine hydrochloride as active pharmaceutical ingredient for the treatment of premature ejaculation. Dapoxetine belongs to the category of selective serotonin reuptake inhibitor – SSRIs with a short half-life of merely 1 or 2 hours. It helps getting the apex plasma levels within one hour so in short the drug effect gets in faster and gets out faster as well.

The short half-life means that the males could probably take this medication when required instead of relatively building up the typical level in the body like that of the traditional SSRIs due to the short half-life it does not gather in the system and source other side effects like loss of libido. It can be taken 1–3 hours before sexual intercourse is anticipated, rather than every day.

Dapoxetine was licensed from PPD-GenuPro in 2001 by Alza Corporation, a Janssen-Cilag affiliate, with exclusive worldwide rights to develop and commercialise the compound for urogenital therapies, including premature ejaculation.

Three additional phase 3 clinical studies using Priligy was conducted by Johnson & Johnson Pharmaceutical Research & Development to expand its clinical dataset to involve 6000 men suffering from premature ejaculation and their partners.

Priligy is the first ever drug and the only oral medication approved for the treatment of premature ejaculation. Priligy has been approved for the treatment of premature ejaculation in Finland, Sweden, Portugal, Austria, Germany, Italy and Spain. Priligy’s regulatory filings are currently under review in the Middle East, Asia Pacific, North America and Latin America.
However, Priligy is yet to be approved in US. The US FDA rejected Priligy in 2005 and asked for clinical data to confirm the safety and efficacy of the drug.

“Our hope is that these data will provide additional safety and efficacy information in support of the Priligy new drug application,” said Fred Eshelman, PPD’s chief executive officer. “We are pleased that our partner Janssen-Cilag continues to obtain clinical data for Priligy in pursuit of additional marketing approvals.”

Johnson & Johnson Pharmaceutical Research & Development will soon take the dataset with the U.S. Food and Drug Administration for review.

What is premature ejaculation?

Experts from the International Society of Sexual Medicine (ISSM) define premature ejaculation as the condition consisting of three major components: a short time to ejaculation (prior to or within about one minute), lack of ejaculatory control and negative personal impact or distress related to ejaculation.

Unlike erectile dysfunction (ED), which tends to affect older men, premature ejaculation has similar prevalence across all age groups. In fact, more men are believed to experience premature ejaculation than ED.

A combination of physiological and psychological factors are believed to influence the mechanism of ejaculation. Men with premature ejaculation appear to go through the same process of ejaculation as other men, but it happens more quickly and with a reduced feeling of control. Research suggests serotonin plays a central role in the timing of ejaculation.
 
Premature ejaculation is a distressing sexual dysfunction that can be present from the first sexual encounter or can develop later in life. Depending on the methodology and criteria used to evaluate the prevalence of premature ejaculation in studies, the reported proportion of men affected with this condition at some point in their lives has ranged from 4–30%.
Nearly 30 percent of males across the world are affected with the condition known as premature ejaculation and in spite of such a remarkable shocking percentage there are hardly any effective medications designed for treating this condition.
 
Head-quartered in Wilmington, NC,  PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs.

The Janssen-Cilag companies are part of the Johnson & Johnson family of companies.  Jannssen- Cilag is developing and marketing treatments for -central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) J&JPRD is part of the Johnson & Johnson family of companies. J&JPRD is headquartered in Raritan, NJ, and has facilities throughout Asia, Europe and the United States.