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New approved oral medication for Premature Ejaculation available in New Zealand

Friday 12 March 2010, 1:32PM

By Priligy & Janssen-Cilag

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PRILIGY® (dapoxetine) has been approved for prescription in New Zealand. The oral, on-demand medication has been specifically developed for the treatment of premature ejaculation (PE).

PRILIGY® is indicated for use in men aged between 18-64 years who present with the three components of the definition of PE:

Persistent or recurrent ejaculation that occurs with minimal stimulation before, on, or shortly after vaginal penetration1,2,3,4,5.

Inability to control or delay ejaculation shortly before or during vaginal penetration1,2,3,4,5.
Negative personal consequences, such as distress1,4,5.

Serotonin is a central regulator of the pathways that control PE

Ejaculation is controlled by neural pathways medicated by the central nervous system. Serotonin (5-hydroxytryptamine [5-HT]) is considered part of a key signalling system that has an inhibitory effect on ejaculation. Reduced levels of serotonin are associated with PE6.

PRILIGY® is an on-demand medication7 that works on the serotonin pathway to improve time to ejaculation, perception of control of ejaculation and associated distress. 8,9

Dr. Warrick White, an Auckland GP specialising in men’s sexual health explains, “PRILIGY® is a short-acting Selected Serotonin Re-uptake Inhibitor (SSRI) with a unique pharmacokinetic profile which acts on the neural pathways that control ejaculation.”

Proven Efficacy and Safety

In the largest and most comprehensive clinical trial programme to date for a PE treatment, involving more than 6,000 men, PRILIGY® was found to be effective from the first dose with continued efficacy throughout the trials.10

PRILIGY® is generally well tolerated and has a low rate of adverse events which are usually mild and moderate in nature11. Due to the medication’s short half-life it is also rapidly cleared from the patient’s system11.

On Demand Medication

Taken 1-3 hours before sex is anticipated PRILIGY® was found to significantly increase the time to ejaculation, improve a man’s sense of control during sexual intercourse and reduce associated distress, with men and their partners reporting increased satisfaction with intercourse overall. 8,9

“Taken on-demand and effective within one hour, PRILIGY® has been proven to address the
three key components of PE – time, control and distress” 9, says Dr. White.

Prescribing PRILIGY®

When prescribing PRILIGY® general practitioners should consider a number of important points:

Ensure only men aged 18-64 years with diagnosed PE are prescribed PRILIGY®.
PRILIGY® should be taken by men affected by PE 1–3 hours prior to sexual intercourse.
No more than one dose should be taken in a 24-hour period.
PRILIGY® is available in two doses, 30mg and 60mg. The recommended starting dose is 30mg, with a 60mg dose for patients who do not respond satisfactorily to the 30mg dose.
The risks and patient-reported benefits of the therapy should be evaluated after the first four weeks of treatment or after six doses to assess the patient risk-benefit balance and to determine whether continuing treatment with PRILIGY® is appropriate.
PRILIGY® should be taken with at least one full glass of water, with or without food.
PRILIGY® should not be taken when dehydrated, and patients should be advised not to combine PRILIGY® with alcohol.
As with any medicine, patients should be made aware of possible effects of PRILIGY® which are usually mild or moderate and occur at a low rate.
Patients should be reminded of the dangers of counterfeit medicine. Packs of PRILIGY® incorporate security features that allow the patient to confirm they have purchased genuine PRILIGY®.
Patients should be reminded that PRILIGY® is an unfunded prescription medicine that can only be dispensed from authorised New Zealand pharmacies in packs of three.
The indicative price for PRILIGY® 30mg is $58.00 for packs of three and $72.00 for 60mg tablets in packs of three.

“GPs can now play a greater role in helping New Zealand men and their partners affected by premature ejaculation enjoy a more satisfying sex life”, adds Dr. White.

For further information on PRILIGY® visit www.priligy.co.nz