DTB | Lidocaine/prilocaine spray for premature ejaculation

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DTB CME/CPD*
Lidocaine/prilocaine spray
for premature ejaculation
Although premature ejaculation is the most common ejaculation problem, it is poorly understood and currently
has no standard definition.1 Typically, it involves reduced time to ejaculation, inability to control or delay
ejaculation and associated distress.1-5 Treatments that have been assessed include psychosexual counselling,
antidepressants (e.g. selective serotonin reuptake inhibitors), phosphodiesterase type-5 inhibitors, tramadol and
topical anaesthetic agents (e.g. lidocaine/prilocaine cream). A new formulation (cutaneous spray) of lidocaine/
prilocaine (Fortacin-Plethora Solutions Ltd.) was launched in the UK in November 2016 for the treatment of
primary premature ejaculation.6,7 Here, we consider the evidence for lidocaine/prilocaine spray and whether it has
a role in the treatment of premature ejaculation.

About premature ejaculation Treatment options

Many definitions of premature ejaculation specifically refer to vaginal
penetration and are only applicable to heterosexual relationships.2,3 Primary
(lifelong) premature ejaculation, with onset from the first sexual experience,
is an ongoing problem of ejaculation usually occurring before, or within 1–2
minutes of vaginal penetration. 3 This compares to a median intravaginal
ejaculatory latency time (IELT) of around 5 minutes in multinational population
studies.4 Primary premature ejaculation has an estimated prevalence of
2–5%.1,3-5 Apart from primary (lifelong) premature ejaculation, the condition
may also be acquired (e.g. related to anxiety, stress, prostatitis or erectile
dysfunction) or situational (under specific circumstances or with a specific
partner).1 Men with premature ejaculation may report low satisfaction with
their sexual relationship and sexual intercourse, difficulty relaxing during
intercourse and less frequent intercourse.1 Premature ejaculation can impair
self-confidence and the relationship with a partner, and may cause distress,
anxiety, embarrassment and depression.1
The aetiology and pathophysiology are unknown,1 although it may be
associated with dysregulation of the central mechanism of ejaculatory
function (of which serotonin is the predominant central mediator) and/or
peripheral factors (penile hypersensitivity).1,8,9
Obtaining a thorough history is important, including questions about IELT, the
ability to delay ejaculation, the impact on the person and their partner,
whether the condition is lifelong and occurs with almost every attempt at
intercourse with every partner, and identifying comorbid conditions (e.g.
erectile dysfunction, depression, anxiety).4,9
Various outcome measures have been used in trials of treatments for
premature ejaculation (see Box). Outcomes may not be comparable across
trials due to variations in the definition of premature ejaculation and patient
inclusion criteria.14
Box: Outcome measures used in trials10-13
IELT—Intravaginal ejaculatory latency time: a three- to four-fold increase
in IELT has been suggested as a clinically significant response.
IPE—Index of Premature Ejaculation: 10-item subjective questionnaire
answered on a six-point scale (ejaculatory control [four questions], sexual
satisfaction [four questions] and distress [two questions]). Low scores
indicate least control/satisfaction or most distress.
PEP—Premature Ejaculation Profile for patients and their sexual partners: four
questions answered on a five-point scale relating to satisfaction, distress,
control and interpersonal difficulty. A high score represents a better outcome.
Psychosocial and behavioural
interventions
In men for whom premature ejaculation causes few problems, psychosexual
counselling and education may help.1 However, evidence for psychosocial
interventions is inconsistent and patients may relapse after treatment ends.9,15
Various behavioural techniques can be learned to improve control over
ejaculation.16 A systematic review included three randomised controlled trials
(RCTs; n=82) of behavioural techniques among men with primary premature
ejaculation.17 One study found no significant difference between behavioural
techniques and a waiting list control group. The two studies that compared
behavioural techniques with selective serotonin reuptake inhibitors (SSRIs)
favoured drug therapy.17
Drug therapy
For primary premature ejaculation, drugs may be used alongside psychosexual
therapy.18,19 However, there are few studies on long-term efficacy,20 and in the
UK, dapoxetine is the only drug other than lidocaine/prilocaine spray licensed
for premature ejaculation.2
SSRIs
A systematic review that assessed SSRIs other than dapoxetine (mostly taken
daily for 4–12 weeks) reported that citalopram (four trials, n=224),
escitalopram (one trial, n=30), fluoxetine (six trials, n=170), paroxetine (two
trials, n=224) and sertraline (five trials, n=188) all increased IELT more than
placebo (mean difference [MD] around 3 minutes, 1 minute, 3 minutes, 5
minutes and 3 minutes, respectively, all p<0.00001).21
The review also included eight RCTs (n=7,088) of dapoxetine (a short-acting
SSRI taken on-demand 1−2 hours before intercourse).21 The authors found that
30mg or 60mg were more effective than placebo at 12 or 24 weeks (MD 1.2
minutes and 1.7 minutes, respectively, both p<0.00001). In a trial involving
* DTB CME/CPD
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subscribers must sign on to DTB with their username and password. All users must
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DTB | Lidocaine/prilocaine spray for premature ejaculation
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50 men with lifelong premature ejaculation, dapoxetine plus behavioural
treatment was more effective than dapoxetine alone (IELT increased from a
baseline of 1.5 minutes to 6.2 minutes at 24 weeks with the combination
compared with an increase from 1.4 minutes to 2.7 minutes with dapoxetine
alone, p<0.0001).22
Phosphodiesterase type-5 inhibitors
A systematic review that included 15 RCTs (most involved men with lifelong
premature ejaculation and without erectile dysfunction) found that
phosphodiesterase type-5 inhibitors were more effective than placebo (MD
around 2 minutes at 4–12 weeks, p<0.00001; three trials, n=231) or
behavioural techniques (MD 3.6 minutes at 12–24 weeks, p<0.00001; one trial,
n=120) but not significantly different from SSRIs (MD 0.3 minutes at 4–24
weeks, p=0.50; six trials, n=405).23
Tramadol
A meta-analysis of four RCTs (n=721) concluded that tramadol improved
outcomes in men with premature ejaculation (a difference in IELT from
placebo of 1.2 minutes at 8–12 weeks, p=0.0007).24 However, these findings
should be interpreted with caution, given statistical heterogeneity between
the trials and concerns over the methodological quality of the studies.24
Local anaesthetic cream
Topical local anaesthetics reduce peripheral stimulation and increase the
threshold for orgasm.9 A meta-analysis of two RCTs (49 men with lifelong
premature ejaculation) of a topical local anaesthetic cream containing
lidocaine (25mg/g) and prilocaine (25mg/g) reported that it prolonged IELT by
around 6 minutes compared with placebo over 30-60 days (p<0.00001).25
Other
Condoms containing benzocaine and lidocaine are commercially available, as
are condoms with shapes designed to delay ejaculation; these are regulated
in the UK by the Medicines and Healthcare Products Regulatory Agency
(MHRA) as medical devices.26
Lidocaine/prilocaine spray
Lidocaine/prilocaine spray is a combination of the two local anaesthetics
(150mg/mL and 50mg/mL, respectively), dissolved in tetrafluoroethane
solvent, which also acts as a propellant.6 Each dose (three sprays) consists
of a total of 22.5mg lidocaine and 7.5mg prilocaine.
Before use, the spray container should be briefly shaken and primed by
spraying it into the air.6 Any foreskin should be retracted and one dose
applied (three actuations of the valve, each covering a third of the glans
penis). After 5 minutes, any excess spray should be wiped off prior to
intercourse.6 A maximum of three doses can be used within 24 hours, with
at least 4 hours between doses.
Lidocaine/prilocaine has a rapid onset and is effective within 5 minutes of
application.6 The drugs are absorbed rapidly through the glans penis mucosa,
but not through the keratinized skin of the shaft of the penis, resulting in low
systemic exposure.6
What’s the evidence for lidocaine/
prilocaine spray?
Three RCTs recruited heterosexual men (aged >18 years) with primary
premature ejaculation who were in a monogamous relationship for at least 3
months prior to study entry (the effect in homosexual men, or heterosexual
men with multiple partners has not been studied).27 Although studies were
designed as double-blind placebo-controlled trials, the numbing effects of
lidocaine/prilocaine may have caused unblinding and bias.26 Men with erectile
dysfunction were excluded from the trials, as were those taking tricyclic
antidepressants, monoamine oxidase inhibitors or SSRIs, where the dose had
changed within 4 weeks or was anticipated to change.26
46 | DTB | Vol 55 | No 4 | April 2017dtb.bmj.com
All three trials were funded by the company (Plethora Solutions Ltd). Some of
the authors of the publications were funded by the manufacturer and/or were
directors, shareholders, consultants to and investigators for
the manufacturer.11,28,29
In one study, 62 men used lidocaine/prilocaine spray or placebo 15 minutes
before intercourse.28 Baseline IELT was around 1 minute in both groups. The
mean change in IELT from baseline to 10 weeks was greater with active
treatment than placebo (3.8 minutes vs. 0.7 minutes; treatment difference
3.1 minutes); after adjustment for baseline value and study centre, IELT was
2.4-fold higher with active treatment than placebo (p<0.01). There was no
difference on a quality of life measure between the groups. In the active
treatment group with post-baseline data, 15% of men had a mild or moderate
treatment-related adverse events, including numbness of the penis or erectile
dysfunction. One female partner reported a mild burning sensation during
intercourse each time the spray was used.
In a second study, 300 men with an IELT ≤1 minute at baseline used lidocaine/
prilocaine or placebo 5 minutes before intercourse.29 The mean IELT increased
from a baseline of 0.6 minutes in both groups to 3.8 and 1.1 minutes in the
lidocaine/prilocaine and placebo groups, respectively, at 3 months (treatment
difference 2.7 minutes). Adjusting for treatment-group imbalances, this
represented a 6.3-fold and 1.7-fold increase in mean IELT (p<0.001). Scores for
the IPE domains of ejaculatory control and sexual satisfaction increased more
with active treatment than with placebo (MD 7.0 points and 5.9 points,
respectively, both p<0.001). Localised non-serious treatment-related adverse
events were reported by 2.6% of patients in the active treatment group
(mainly genital erythema and erectile dysfunction) and 3.1% of partners
(mainly vulvovaginal burning sensations; the use of condoms was not
permitted during this study).
In a third study, 256 men with an IELT ≤1 minute at baseline used lidocaine/
prilocaine or placebo 5 minutes before intercourse.11 At baseline, the mean
IELT was 0.6 minutes for the active treatment group and 0.5 minutes for the
placebo group. At 3 months, IELT increased to 2.6 minutes (4.6-fold increase)
and 0.8 minutes (1.5-fold increase) with lidocaine/prilocaine or placebo,
respectively, a treatment difference of 1.8 minutes (treatment effect was
3 times that of placebo; p<0.0001). There were significantly greater increases
from baseline in the IPE scores with active treatment than with placebo
(p<0.0001). In the active treatment group, 10.2% of patients reported
non-serious treatment-related adverse events, including erectile dysfunction
and hypoaesthesia, while 10.8% of the partners experienced treatment-
related adverse events including vulvovaginal burning sensation, discomfort,
pain or pruritus.
Further data on open-label follow up is available in the European Medicines
Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP)
assessment report, but these data have not been published in a peer-
reviewed journal.26,27 The CHMP report concluded that, although there are
some data on use at 12 months that do not suggest loss of efficacy, the
evidence regarding the maintenance of the effect was limited.27
We are not aware of any published studies that have directly compared
lidocaine/prilocaine with other treatment options.
Unwanted effects, cautions
and contraindications
In addition to the adverse effects mentioned above, unwanted effects
include deterioration of male or female condoms made from polyurethane
after exposure.6
Lidocaine/prilocaine spray is contraindicated if either the patient or their
partner is hypersensitive to the active substances or the excipient
(norflurane) or have a history of sensitivity to local anaesthetics of the amide
type (e.g. bupivacaine).6,30
The company advises caution in patients taking class III anti-arrhythmic drugs
(e.g. amiodarone) but no further details are provided.6
Care should be taken not to allow lidocaine/prilocaine spray to come in
contact with eyes, as it may cause eye irritation, and the loss of protective
reflexes, permitting potential abrasion.6
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Cost
Lidocaine/prilocaine spray costs £100 per pack of 20 doses. 31
For comparison, 20 doses of dapoxetine 30mg cost £88.27. 32 A 30g tube of
lidocaine 2.5%/prilocaine 2.5% cream (EMLA; off-label use) costs £12.30.
Based on the assumption that one tube is likely to provide at least 30 doses
(when the cream is used as a thin layer) the comparison cost for 20 doses
would be £8.20.
Assuming on-demand dosing once every 7 days,26 20 doses of lidocaine/
prilocaine spray would be equivalent to 140 days of daily dosing, which would
cost £7.28 for paroxetine 20mg/day, £5.65 for sertraline 50mg/day and £4.06
for fluoxetine 20mg/day (all off-label use). 32
What guidelines say
The 2016 European Association of Urology guidelines recommended
pharmacotherapy (either dapoxetine on demand or other antidepressants
e.g. daily SSRIs, off-label) as first-line treatment of lifelong premature
ejaculation.1 Off-label topical anaesthetic agents were suggested as an
alternative.1 In lifelong premature ejaculation, behavioural techniques were
not recommended for first-line treatment because they are time-intensive,
require the support of a partner, can be difficult to perform, and long-term
outcomes are unknown.1
The International Society of Sexual Medicine (ISSM) guidelines suggest that
pharmacological, psychological/behavioural, educational and combination
interventions may be appropriate and that choice of treatment should be
guided by patient preference and a biopsychosocial assessment. 33
The National Institute for Health and Care Excellence (NICE) and the Scottish
Medicines Consortium (SMC) have not issued guidance on lidocaine/
prilocaine. In the absence of a submission from the holder of the marketing
authorisation, the All Wales Medicines Strategy Group (AWMSG) has stated
that neither dapoxetine nor lidocaine/prilocaine can be endorsed for use
within NHS Wales for the treatment of primary premature ejaculation in
adult men. 34,35
Lidocaine/prilocaine spray is a prescription-only medicine available via a
private prescription.6 However, it has not been added to Part XVIIIA (Drugs,
medicines and other substances not to be ordered under a General Medical
Services Contract) or Part XVIIIB (Drugs, medicines and other substances that
may be ordered only in certain circumstances) of the Drug Tariff and,
therefore, could be ordered on an FP10. 32

Conclusion
Premature ejaculation is associated with distress and reduced sexual satisfaction in men and their partners. Primary (lifelong) premature ejaculation is less
common than the acquired condition. Treatment options include counselling, behavioural techniques and drug therapy. The selective serotonin reuptake
inhibitor (SSRI) dapoxetine is licensed in the UK for on-demand treatment and in trials has been shown to result in a mean increased ejaculatory latency of
around 1–2 minutes. Evidence from a number of studies involving relatively small numbers of men has shown that use of daily SSRIs (off-label) increased
ejaculatory latency by 1–5 minutes, while two small studies have shown that a local anaesthetic cream (e.g. 2.5% lidocaine and 2.5% prilocaine; off-label)
increased ejaculatory latency by up to 6 minutes.
Lidocaine/prilocaine spray (150mg/mL and 50mg/mL, respectively) is licensed for the topical treatment of primary premature ejaculation. A few short-term
studies funded by the company have shown that in heterosexual men with stable relationships there was a mean increase in ejaculatory latency of 2–3
minutes compared with placebo spray. Men with erectile dysfunction were excluded from these trials, although erectile dysfunction and premature
ejaculation often co-exist. We found no published studies that compared lidocaine/prilocaine spray with alternative active treatments. Unwanted effects
include erectile dysfunction and genital hypoaesthesia among men, and vulvovaginal burning sensation, discomfort, pain or pruritus in their partners. In
addition, the product is noted to reduce the strength of polyurethane condoms. Long-term benefits or harms are unknown. Although lidocaine/prilocaine
spray is available via a private prescription and costs £100 for a device that will deliver 20 doses, its status within NHS prescribing needs clarifying. As it is
considerably more expensive than off-label use of a SSRI or lidocaine/prilocaine cream, we do not recommend lidocaine/prilocaine topical spray as
first-line therapy.

[R=randomised controlled trial; M=meta-analysis]
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DOI: 10.1136/dtb.2017.4.0469

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Lidocaine/prilocaine spray for premature

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