How Effective Is Priligy?

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Priligy is one of the treatments for erectile dysfunction available for sale here at Assured Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about the effectiveness of Priligy. We’ll cover what Priligy is, what it is used for, the mechanism of action and what the results from clinical trials say about the effectiveness of Priligy.

 

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What is Priligy?

Priligy is the brand name for a medication known as Dapoxetine Hydrochloride. It belongs to the pharmacotherapeutic group known as Other Urologicals.
Each film−coated tablet of Priligy contains Dapoxetine hydrochloride equivalent to 30 mg or 60 mg Dapoxetine.
The excipient (other substance in the tablet) with known effect is Lactose. Each 30 mg tablet of Priligy contains 45.88 mg of lactose. Each 60 mg tablet of Priligy contains 91.75 mg of lactose.
The other substances (excipients) in each Priligy tablet (that are inactive) include:

Tablet core:

  • Lactose monohydrate
  • Microcrystalline cellulose
  • Croscarmellose sodium
  • Colloidal anhydrous silica
  • Magnesium stearate

Tablet coating:

  • Lactose monohydrate
  • Hypromellose
  • Titanium dioxide (E171)
  • Triacetin
  • Iron Oxide Black (E172)
  • Iron Oxide Yellow (E172)

The legal category for Priligy (Dapoxetine) is POM. This means that this medication is a prescription only medicine and it can only be supplied or sold according to the instructions in a prescription issued by a duly qualified and registered doctor or non-medical prescriber.
You should not buy this or any other prescription-only medication without first speaking to a duly qualified and registered healthcare professional like a doctor or non-medical prescriber.

Priligy (Dapoxetine)

From: £24.00

What is Priligy used for?

Priligy (Dapoxetine) is indicated for the treatment of premature ejaculation in men aged 18 to 64 years of age who meet all of the following criteria:

  • Poor control over ejaculation,
  • A history of premature ejaculation over the past 6 months in most intercourse attempts,
  • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
  • Marked personal distress or interpersonal difficulty because of premature ejaculation, and
  • An intravaginal ejaculatory latency time of less than two minutes

 

What is the mechanism of action Priligy?

Priligy (Dapoxetine) is a potent selective serotonin reuptake inhibitor (SSRI) with an IC50 of 1.12 nM, while its major human metabolites, desmethyldapoxetine (IC50 < 1.0 nM) and didesmethyldapoxetine (IC50 = 2.0 nM) are equivalent or less potent (dapoxetine-N-oxide (IC50 = 282 nM)).
Human ejaculation is primarily mediated by the sympathetic nervous system. The ejaculatory pathway originates from a spinal reflex centre, mediated by the brain stem, which is influenced initially by a number of nuclei in the brain (medial preoptic and paraventricular nuclei).
The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter’s action at pre− and postsynaptic receptors.
In the rat, dapoxetine inhibits the ejaculatory expulsion reflex by acting at a supraspinal level within the lateral paragigantocellular nucleus (LPGi). Postganglionic sympathetic fibres that innervate the seminal vesicles, vas deferens, prostate, bulbourethral muscles and bladder neck cause them to contract in a coordinated fashion to achieve ejaculation. Dapoxetine modulates this ejaculatory reflex in rats.

 

How effective is Priligy?

According to the Marketing Authorisation holder of Priligy (Dapoxetine), the effectiveness of Priligy in the treatment of premature ejaculation has been established in five double−blind, placebo−controlled clinical trials, in which a total of 6081 subjects were randomized. The subjects were 18 years of age or older and had a history of PE in the majority of intercourse experiences in the 6−month period prior to enrolment. Premature ejaculation was defined according to the DSM-IV diagnostic criteria: short ejaculatory time (an intravaginal ejaculatory latency time [IELT; time from vaginal penetration to the moment of intravaginal ejaculation] of ≤ 2 minutes measured using a stopwatch in four studies), poor control over ejaculation, marked distress or interpersonal difficulty due to the condition.
The subjects with other forms of sexual dysfunction like erectile dysfunction, or those using other forms of pharmacotherapy for the treatment of PE were excluded from all studies.
The results of all the randomized studies were consistent. The efficacy of Priligy (Dapoxetine) was demonstrated after 12 weeks of treatment. One study enrolled patients both outside and within the EU and had a treatment duration of 24 weeks. In the study, 1162 subjects were randomized, 385 to placebo, 388 to Priligy 30 mg as needed, and 389 to Priligy 60 mg as needed. The mean and median Average IELT at study end are presented in Table 1 below and the cumulative distribution of subjects who achieved at least a specific level in Average IELT at study end are presented in Table 2 below. Other studies and pooled analysis of the data at Week 12 gave consistent results.

Average IELTPlaceboPriligy 30mgPriligy 60mg
Median1.05 min1.72 min1.91 min
Difference from placebo [95% CI]0.6 min**
[0.37,0.72]
0.9 min**
[0.66,1.06]
Least Squares Mean1.7 min2.9 min3.3 min
Difference from placebo [95% CI]1.2 min**
[0.59, 1.72]
1.6 min**
[1.02, 2.16]

* Baseline value carried forward for subjects with no post-baseline data

** Difference was statistically significant (p-value <=0.001).

IELT
(mins)
Placebo
%
Priligy 30mg
%
Priligy 60mg
%
≥1.051.668.877.6
≥2.023.244.447.9
≥3.014.326.037.4
≥4.010.418.427.6
≥5.07.614.319.6
≥6.05.011.714.4
≥7.03.99.19.8
≥8.02.96.58.3

* Baseline value carried forward for subjects with no post-baseline data

 

The magnitude of the IELT prolongation was related to the baseline IELT and was variable between individual subjects. The clinical relevance of Priligy (Dapoxetine) treatment effects was further demonstrated in terms of various patient reported outcome measures and a responder analysis.
A responder was defined as a subject who had at least a 2−category increase in control over ejaculation plus at least a 1−category decrease in ejaculation−related distress. A statistically significantly greater percentage of subjects responded in each of the Priligy groups versus placebo at the end of the study Week 12 or 24. There was a higher percentage of responders in the Priligy (Dapoxetine) 30 mg (11.1% – 95% CI [7.24; 14.87]) and 60 mg (16.4% – 95% CI [13.01; 19.75]) groups compared with the placebo group at Week 12 (pooled analysis).
The clinical relevance of Priligy (Dapoxetine) treatment effects is represented by treatment group for the subject’s Clinical Global Impression of Change (CGIC) outcome measure, in which patients were asked to compare their premature ejaculation from the start of the study, with response options ranging from much better to much worse. At study end (Week 24), 28.4% (30 mg group) and 35.5% (60 mg group) of subjects reported their condition to be “better” or “much better”, compared to 14% for placebo, while 53.4% and 65.6% of subjects treated with Priligy (Dapoxetine) 30 mg and 60 mg, respectively, reported their condition to be at least “slightly better”, compared to 28.8% for placebo.

 

Absorption

Priligy (Dapoxetine) is rapidly absorbed with maximum plasma concentrations (Cmax) occurring approximately 1-2 hours after tablet intake. The absolute bioavailability is 42% (range 15−76%), and dose proportional increases in exposure (AUC and Cmax) are observed between the 30 and 60 mg dosage strengths. Following multiple doses, AUC values for both Priligy (Dapoxetine) and the active metabolite desmethyl dapoxetine (DED) increase by approximately 50% when compared to single dose AUC values.
Ingestion of a high-fat meal modestly reduced the Cmax (by 10%) and modestly increased the AUC (by 12%) of Priligy (Dapoxetine) and slightly delayed the time for Priligy (Dapoxetine) to reach peak concentrations. These changes are not clinically significant. Priligy (Dapoxetine) can be taken with or without food.

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Is there anything else I need to know about Priligy?

This medicine may make you sleepy. If this happens, do not drive or use tools or machines. Do not drink alcohol.
You should also swallow this medicine whole with at least a full glass of water. Do not crush or chew the tablet.
A physical examination may be needed before treatment with Priligy (Dapoxetine) can be initiated.
Whilst on Priligy (Dapoxetine), if you experience symptoms like light-headedness soon after standing, you should immediately lie down flat but ensure that your head is lower than the rest of your body or sit down with your head between his knees until the symptoms pass. Also, you should not get up quickly after prolonged lying or sitting.
Due to risks of symptoms like dizziness and light-headedness occurring, it is advisable to avoid situations that could lead to an injury like driving or operating hazardous machinery.
You should not take any alcohol whilst on Priligy. This is because the Priligy-alcohol combination increases the risks of alcohol-related neurocognitive effects and may also enhance neurocardiogenic effects like syncope, thereby increasing the risk of injury occurring. Syncope is a temporary loss of consciousness due to a sudden drop in blood pressure. Self-rated alertness has been reported as being significantly decreased when alcohol is taken with Priligy.

 

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If you would like more information about Priligy (Dapoxetine), please click here to fill out our contact form. Alternatively, you may call us on 01625 460 621.
Should you need urgent medical assistance, please dial 999.
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References

  1. https://www.medicines.org.uk/emc/search?q=%22Priligy%22
  2. https://www.medicines.org.uk/emc/product/1269/smpc#EXCIPIENTS
  3. https://bnf.nice.org.uk/medicinal-forms/dapoxetine.html
  4. https://www.medicines.org.uk/emc/product/1269/smpc#INDICATIONS
  5. https://www.medicines.org.uk/emc/product/1269/smpc#POSOLOGY
  6. https://www.medicines.org.uk/emc/product/1269/smpc#CLINICAL_PRECAUTIONS
  7. https://www.medicines.org.uk/emc/product/1269#PHARMACODYNAMIC_PROPS
  8. https://www.medicines.org.uk/emc/product/1269#PHARMACOKINETIC_PROPS

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]