PRILIGY - NOW AVAILABLE FROM DRM
Men suffering from premature ejaculation can now, for the first time, take a pill that reportedly triples the time to climax, as Janssen-Cilag's Priligy has become available from DRM via a special Internet service.
While the drug is not specifically licensed to combat premature ejaculation in the UK (a marketing application has not yet been submitted), it is approved for this use in several other European countries and is thus available over here too, but only after an online consultation with a doctor.
As from this week, men suffering from premature ejaculation, which is thought to affect around 30% of the male population at some point in their lives, can get their hands on the Priligy (dapoxetine) by completing an online form for a private prescription for the drug, if suitable.
Originally marketed as an antidepressant, Priligy is a short-acting selective serotonin reuptake inhibitor that works by altering the levels of serotonin - the hormone responsible for ejaculation - in the brain to give men a greater degree of control, and trials in more than 6,000 patients showed that it can increase the time to ejaculation by a factor of three.
Before the arrival of Priligy, which comes in packs of three and costs roughly 30 a pill (including prescription etc), the only therapies men with premature ejaculation had available to them was a variety of local anaesthetic sprays and creams, condoms (to reduce sensitivity), counselling and certain ‘behavioural techniques’ to help delay orgasm, and so news of a new treatment will be very welcome indeed.
Same potential as Viagra?
"Priligy has the potential to do as much for men's sexual health as Viagra, as it will give sufferers a chance to improve the quality of their relationships and their general wellbeing," said Nitin Makadia, head of male sexual health. "It has been well received by men elsewhere in Europe".
According to findings of a European study, more than half of men suffering from premature ejaculation have not spoken to anyone about their condition, of which almost half said they were too embarrassed to seek help and another 28% felt it wasn't a 'proper' medical condition and therefore untreatable.
But the hope is that, by enabling patients to receive treatment without the need for a face-to-face consultation, more men will be prompted to get help for the condition.
Priligy First Oral Prescription Medication Approved for PE BEERSE, Belgium, February 10
BEERSE, Belgium, February 10 /PRNewswire-FirstCall/ -- Janssen-Cilag
EMEA, a division of Janssen Pharmaceutica N. V., announced today that
Priligy(TM) (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. These approvals follow the positive outcome of a decentralised
marketing authorisation procedure in seven European Union countries: Sweden,
Austria, Finland, Germany, Spain, Italy and Portugal. The procedure was
finalised in December 2008, and Finland and Sweden are the first countries
worldwide to grant marketing authorisation for this compound. National
approvals and licenses in the other five European countries are expected to
follow. Dapoxetine is not approved for marketing in the United States.
Dapoxetine is a drug specifically developed for the on-demand treatment
of PE and is the first oral medication (tablet) to be approved for this
condition. Dapoxetine has been extensively evaluated in five randomised,
placebo-controlled Phase III clinical trials involving more than 6,000 men
with PE and their partners. This is the largest and most comprehensive
clinical trial programme to date for a drug therapy to treat PE. Dapoxetine
is a unique, short-acting, selective serotonin reuptake inhibitor (SSRI)
designed to be taken only when needed, that is 1-3 hours before sexual
intercourse is anticipated, rather than every day.
Dapoxetine will be marketed by Janssen-Cilag, marking another significant
advance in the company's commitment to developing innovative, high quality
treatments for unmet medical needs.
PE 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 PE in studies, the reported
proportion of men affected with this condition at some point in their lives
has ranged from 4-30%. Experts in PE from the International Society of Sexual
Medicine (ISSM) define the condition as 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, PE has similar prevalence across all age groups. In fact, more men are
believed to experience PE than ED.
A combination of physiological and psychological factors are believed to
influence the mechanism of ejaculation. Men with PE 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.
ALZA Corporation, a Janssen-Cilag affiliate, licensed dapoxetine from
PPD-GenuPro in 2001 with exclusive worldwide rights to develop and
commercialise the compound for urogenital therapies, including premature
The clinical trial programme for the use of dapoxetine in premature
ejaculation was conducted by Johnson & Johnson Pharmaceutical Research and
Development. The product will be marketed by Janssen-Cilag in most countries
where regulatory approval has been granted.
After approval in a specific country, Priligy (dapoxetine) will only be
available by prescription from a healthcare professional.
The product is expected to be made available for purchase in licensed
pharmacies in the countries where approved around April 2009, after all local
regulatory requirements related to packaging and pricing are finalised.
Janssen-Cilag will provide official confirmation of the exact date of product
availability in each individual country. Applications for marketing
authorisation in other countries are under review.
Unapproved imitations (counterfeit) of dapoxetine have been sold.
Government officials from around the world have warned of the potential risks
associated with counterfeit drugs, including the risk of death. As for any
prescription medication, patients should buy Priligy (dapoxetine) only from a
pharmacy that is officially licensed by government authorities. Patients
should be especially cautious of internet pharmacies, as many of these are
The Janssen-Cilag companies are part of the Johnson & Johnson family of
companies. They have a long track record in developing and marketing
treatments for central nervous system disorders, pain management, oncology,
infectious diseases, reproductive health and gastrointestinal disorders. More
information about Janssen-Cilag can be found at http://www.janssen-cilag.com.
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. J&JPRD is leveraging drug discovery and drug development
in a variety of therapeutic areas to address unmet medical needs worldwide.
(This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. These statements are
based on current expectations of future events. If underlying assumptions
prove inaccurate or unknown risks or uncertainties materialise, actual
results could vary materially from Janssen-Cilag's expectations and
projections. Risks and uncertainties include general industry conditions and
competition; economic conditions, such as interest rate and currency exchange
rate fluctuations; technological advances and patents attained by
competitors; challenges inherent in new product development, including
obtaining regulatory approvals; domestic and foreign health care reforms and
governmental laws and regulations; and trends toward health care cost
containment. A further list and description of these risks, uncertainties and
other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report
on Form 10-K for the fiscal year ended December 31, 2007. Copies of this Form
10-K, as well as subsequent filings, are available online at
http://www.sec.gov, www.jnj.com or on request from Johnson & Johnson.
Janssen-Cilag does not undertake to update any forward-looking statements as
a result of new information or future events or developments.)