Eroxon®

A Breakthrough Treatment in Erectile

Dysfunction
Unmet needs in
ED management
The prevalence of ED will increase from 152 million men
in 1995 to 322 million men by 20251

Asia
North America Europe
↑ 113 million
↑ 9.1 million ↑ 11.9 million

Africa
South/Central ↑ 19.3 million
America and
Caribbean Oceania
↑ 15.6 million ↑ 0.9 million

ED: erectile dysfunction

References: 1. Adapted from McKinlay JB. Int J Impot Res. 2000;12(suppl 4):S6-S11.
 Despite huge improvements in ED treatment over the years, there
remains a need for innovation1

Pre-1960 1960s / 70s 1980s mid 1990s 1998 21st Century

Early surgery / Pumps Implants Prescribed injections PDE5 inhibitors Future treatments
natural remedies

Expectation
Successful
Any improvement
Erection of a normal
sex Life

ED: erectile dysfunction; PDE5i: phosphodiesterase type 5 inhibitor

References: 1. Hackett GI. Eur Urol 2002:1;4-11
Oral PDE5 inhibitors are the standard of care for ED but
do not meet the needs of many men or their partners1

Up to 50% of patients currently discontinue

Limitations to PDE5 inhibitors:
ED treatment* within 1 year,6 owing to:

• Mostly available on prescription, which may act as • Insufficient efficacy, and side-effects7–9
a barrier to seeking treatment1,2 • Barriers to spontaneity and intimacy (pre-planning
• Typical time to onset of 30-60 minutes;3 requires for sex)9
planning to use effectively • Certain medications are contraindicated4,5
• Contraindicated in patients taking certain
medications, such as nitrates3–5
• Prone to misuse as a recreational drug.10

*Intercavernosal injection, vacuum device, oral PDE5i, topical intraurethral products.

ED: erectile dysfunction, PDE5: phosphodiesterase type 5, PDE5i: phosphodiesterase type 5 inhibitor
References: 1. Jannini EA. J Sex Med. 2014;11(1):40–50. 2. Gagnon-Arpin I. Value of Consumer Health Products: The Impact of Switching Prescription Medications to Over-the-Counter. Ottawa: The Conference Board of Canada, 2017. 3. Viagra Connect
Patient Information Leaflet. https://www.healthinfouk.org.uk/useful-information/erectile-dysfunction/patient-information-leaflet-pil-for-viagra-sildenafil/. Accessed March 2023. 4. BSSM, British Society for Sexual Medicine. 2017 Guidelines for the
management of erectile dysfunction. 5. BSSM Practical Guide ED Management 2018 , 6. Carvalheira AA et al. J Sex Med. 2012;9(9):2361–2369. 7. Rosen RC et al. Curr Med Res Opin. 2004;20(5):607–617. 8. DiMeo PJ. Urol Nurs. 2006;26(6):442–446.
9. McCabe MP et al. Int J Impot Res. 2010;22(2):152–158. 10. Bechara A et al. J Sex Med. 2010;7(11):3736-42.
There is need for a fast-acting, effective and well-tolerated
treatment for ED, that is inclusive of the partner

Works Enables
• ED is associated with reduced QoL for the in 10 Minutes spontaneity
patient, which can also impact the partner1,2
• ED can adversely impact patient self-esteem
and relationships, causing severe distress2 EFFICACIOUS
• Partners can play a key supportive role
in ED treatment, leading to successful
long-term therapy3 Excellent Restores
Safety Profile intimacy

ED: erectile dysfunction, QoL: quality of life

References: 1. Jannini EA. J Sex Med. 2014;11(1):40–50. 2. Tomlinson JM, Wright D. BMJ. 2004;328(7447):1037.Epub 2004 Mar 29. 3. Dean RC, Lue TF. Int J Clin Pract. 2008;62(1):127–133.
What is Eroxon ?
®
 Eroxon® will be the first topical, clinically proven,
over-the-counter ED treatment in Europe ,UK and US1

• Clinically proven: to be effective in mild,

moderate and severe ED2
• Topical application: with minimal side-effects
and no adverse drug interactions2

• Fast-acting: 60% of erections were reported

within 10 minutes2,3
• Inclusive: In clinical studies, approximately
one third of all applications were made by
the partner as part of foreplay2

ED: erectile dysfunction, UK: United Kingdom

References 1.FDA Approval Received June 2023.
2. Data on file, FM57 Clinical Trial Report. 2021. 3. Eroxon® Patient information leaflet. Futura Medical.
Eroxon® is applied as a pea-sized gel onto the glans penis
immediately before sex1

When to use Eroxon® Massage the gel onto the head of the penis
Apply the gel just before sex for about 15 seconds

How to open the tube

Unscrew the cap. Pierce the tube seal with the top of the
cap. Squeeze tube firmly to empty all the contents which
will provide the correct dose (approximately a pea-sized
amount of gel)
How much to apply
Apply all the contents of one tube to the head of your
penis. If you are uncircumcised, gently pull your foreskin
back as far as comfortable before applying the gel
How to apply
You can apply the gel yourself or your partner can apply
the gel as part of foreplay

Reference: 1. Eroxon® Patient information leaflet. Futura Medical.

 Eroxon® has an evaporative effect using volatile
components specifically tailored for the treatment of ED1
1 2 3 4
Application of gel Seconds later Seconds to minutes Minutes later Projected temperature
Combination of Volatile later Ultimately leading to change when gel is
volatile and non- components Recovery warming vasodilation and applied to glans penis.
volatile components. evaporate causing effect and stimulation erection.
rapid cooling. of nerve endings.

Eroxon® promotes sensory stimulation of the nerves on the glans penis by rapid cooling
and recovery warming, leading to rapid smooth muscle relaxation, vasodilation and erection.
Reference: 1. Data on file, in-vitro Temperature Report. 2018.
EROXON® clinical data
 Eroxon® has been clinically proven as effective in two Phase 3
clinical trials conducted in Europe and the USA

Two Phase 3 studies in 297 1 men with mild, moderate and severe
ED comparing improvement in their erectile function2,3 against baseline

FM57 – Conducted in Eastern Europe and used to gain EU CE mark

1 and UKCA mark

FM71 – Conducted in Eastern Europe and USA as a requirement

2 for FDA marketing authorisation.

CE: Conformité Européenne, ED: erectile dysfunction, EU: European Union, FDA: Food and Drug Administration, UKCA: United Kingdom Conformity Assessed, USA: United States of America
References: 1. Safety Analysis set. 2.Data on file, FM57 Clinical Trial Report. 2021. 3. Data on file, FM71 Clinical Trial Report. 2022.
Study FM57
 SEP 2: Were you able to insert your penis into your partner’s vagina
(Yes/No) 1

SEP2: sexual encounter profile question 2

Reference: 1. Data on file, FM57 Clinical Trial Report. 2021.
SEP 3: Did your erection last long enough for successful intercourse
(Yes/No)1

SEP3: sexual encounter profile question 3

Reference: 1. Data on file, FM57 Clinical Trial Report. 2021.
On 60% of occasions, an erection was obtained within
10 minutes of application1

Time from Eroxon® application to erection*1

8% 32%
achieve erection achieve erection in
almost immediately under 5 minutes
Eroxon® can be administered
as part of foreplay, for an
inclusive, spontaneous sexual
experience
60% 75%
achieve erection in achieve erection in
under 10 minutes under 20 minutes

*Time from Eroxon® application to erection in >3000 intercourse attempts. 83% of patients had onset within 30 minutes, a further 7% more than 30 minutes and 10% of patients did not get an erection adequate for intercourse.
References: 1. Data on file, FM57 Clinical Trial Report. 2021.
Eroxon® demonstrated an excellent safety profile,
both for the man and for their partner1–3

Side effect profile – Eroxon®

*Adverse events occurring >2% in any of the four treatment groups (Eroxon® + 0.2% GTN, Eroxon® + 0.4% GTN, Eroxon® + 0.6% GTN and Eroxon® 0.0% GTN)
Reference: 1. Data on file, FM57 Clinical Trial Report. 2021. 2. Ralph D et al. J Sex Med. 2018;15:167–175. 3. BSSM Practical Guide ED Management 2018.
FM71: 24-week Phase 3 study of Eroxon® that includes patients
from the USA1

• A Phase 3 study designed and Phase 3, multi-centre, comparative, randomised,

open-label, home-use, parallel group study of Eroxon®
agreed with FDA CDRH
and tadalafil 5mg in 92 patients over 24 weeks

• Four countries (USA, Bulgaria, 4 week Subjects pre-screening

Georgia and Poland) Run-in period

24 weeks Run-in period to establish degree of

• 24 weeks (as opposed to 12 weeks Treatment period patient’s erectile dysfunction (“Baseline”)
in earlier Phase 3, FM57 used for
EU/UK approval)
Eroxon® Tadalafil
N=46 5mg N=46

1 week Follow
Follow up period up visit

FDA CDRH: Food and Drug Administration Center for Devices and Radiological Health, IIEF-EF: International Index of Erectile Function – Erectile Function, USA: United States of America
References: 1. Data on file, FM71 Clinical Trial Report. 2022.
Eroxon® achieved both primary endpoints over 24 weeks1

FM71 efficacy – Eroxon®

Primary endpoints Mean IIEF–EF change

Week
from baseline1
1. Mean IIEF–EF change from Week 4 4.59
baseline at 24 weeks
Week 8 5.20
Week 12 5.12

2. MCID of at least 4 IIEF–EF units2 Week 16 5.83

Week 20 5.57

Week 24 – Primary
5.73 (P<0.001)
Endpoint 1

FDA: Food and Drug Administration IIEF-EF: International Index of Erectile Function – Erectile Function, MCID: minimal clinically important difference
References: 1. Data on file, FM71 Clinical Trial Report. 2022. 2. Rosen RC et al. Curr Med Res Opin. 2004;20(5):607–617.
FM71: 24-week Phase 3 study of Eroxon® -Clinical efficacy
confirmed
Both Eroxon® and tadalafil were clinically effective at all time points
over 24 weeks1

Mean IIEF-EF change from baseline at 4, 8, 12, Mean IIEF-EF at 4, 8, 12, 16, 20 and 24
16, 20 and 24 weeks for MED3000 weeks for tadalafil 5 mg
25 25

20 20
MCID1 MCID1
15 15
IIEF-EF Units

10 10

IIEF-EF Units
5 5

0
0
Week 4 Week 8 Week 12 Week 16 Week 20 Week 24
Week 4 Week 8 Week 12 Week 16 Week 20 Week 24

Baseline IIEF-EF Change from Baseline IIEF-EF Baseline IIEF-EF Change from Baseline IIEF-EF

Both Eroxon®and tadalafil were clinically effective at all time points

At 24 weeks, 61% Eroxon®users exceeded the MCID1

IIEF-EF: International Index of Erectile Function – Erectile Function,

References: 1. Data on file, FM71 Clinical Trial Report. 2022
. 1. MCID is the minimal clinically important difference (4 IIEF-EF Units), Rosen et al 2011
Eroxon® demonstrated an excellent safety profile versus
tadalafil 5mg in men and their partners1

Eroxon® Eroxon® Tadalafil Tadalafil

AEs - Males
Subjects Total AEs Subjects Total AEs
• Eroxon® achieved a highly favourable side-effect profile
versus tadalafil1
Headache 2 (4.3%) 2 9 (19.1%) 18 • No local side-effects were noted in any female partners
Back pain 0 (0%) 0 2 (4.3%) 2 with Eroxon®1
Non cardiac • Unlike PDE5i’s Eroxon® has no known potential for
0 (0%) 0 2 (4.3%) 4*
chest pain
adverse drug interactions
Nausea 2 (4.3%) 2 0 (0%) 0
• Potential use in ED sufferers using nitrate,
alpha-blocker and antihypertensive medications
Eroxon® Eroxon® Tadalafil Tadalafil
AEs - Females
Subjects Total AEs Subjects Total AEs

Headache 3 (6.4%) 3 0 (0 %) 0

* All occurred on USA African American patients

AE: adverse event, ED: erectile dysfunction, PDE5i: phosphodiesterase type 5 inhibitors, USA: United States of America
References: 1. Data on file, FM71 Clinical Trial Report. 2022
Time to onset in FM71 was consistent with earlier Phase 3

Time from Eroxon® application to erection1 • Eroxon® achieved the onset of

action Q1 endpoint at 10
minutes which was highly
Onset question 1: statistically significant P<0.001
When did you begin to notice your erection starting?
63% subjects met the agreed FDA • Oral tadalafil 5mg did not meet
criteria (Responder) at 10 minutes the onset of action Q1
endpoint at 10 minutes

FDA: Food and Drug Administration, Q: quarter

References: 1. Data on file, FM71 Clinical Trial Report. 2022.
A meta-analysis showed that Eroxon® significantly improved
erectile function compared with placebo data1–3

FM571,2 FM711,3

Eroxon
Eroxon

IIEF-EF: International Index of Erectile Function – Erectile Function

References: 1. Erectile Dysfunction AUA Guideline 2018, Appendix B1, Guideline Statement 8, 2. Data on file, FM57 Clinical Trial Report. 2021, 3. Data on file, FM71 Clinical Trial Report. 2022
Eroxon® is an innovative treatment for ED

Clinically proven: to be effective in mild,

moderate and severe ED1

Topical application: with minimal side-effects

and no known adverse drug interactions1,2

Fast-acting: 60% of erections were reported

within 10 minutes1

Inclusive of partner: In clinical studies, approximately one third

of all applications were made by the partner as part of foreplay1

ED: erectile dysfunction

References: 1. Data on file, FM57 Clinical Trial Report. 2021, 2., Data on file, FM71 Clinical Trial Report. 2022
 EROXON®

AVAILABILITY
Eroxon® Availability in MENA

Eroxon® is now registered as OTC in UAE, Saudi

Arabia, Qatar, Kuwait, Bahrain, Oman, Jordan
and Iraq.
Available in UAE pharmacies as OTC.

Launch in the rest of MENA early 2024.

Marketing Authorization Holder in MENA: Labatec Pharma SA, www.labatecpharma.com

Eroxon® is Available as an over-the-counter ED treatment in KSA,
March 2024

The EU Notified Body issued an assessment of clinical data,

which states:1

“The overall conclusion is that use of MED3000 [Eroxon®]

presents minimal risk to users but provides significant
clinical advantages with regards to efficacy, speed of onset
of action and acceptability compared with other currently
available products to treat ED.”1
Eroxon® is registered as a medical device.
Eroxon® PCT/GB2020/052660 is a registered trademark of Futura
Medical Developments Limited, Guildford, GU2 7YG, UK.
Marketing Authorization Holder in MENA: Labatec Pharma SA,
www.labatecpharma.com

References: 1. BSI Group. MED3000 MDR Clinical Evaluation Assessment Report. October 2022.