TOPICAL ANESTHETIC FOR COSMETIC PROCEDURES
NeuroMed7 is a topical, local anesthetic that can be used for a variety of procedures to improve patient comfort and satisfaction
NeuroMed7 is a rapid onset of action OTC topical anesthetic that contains a combination of lidocaine HCl 4% with trans-dermal penetration/absorption enhancers
It can be used as a topical anesthetic prior to a variety of medical procedures including:
Injections
Trigger point injections
immunizations
Myo-facial paralyzing injections (BOTOX therapy)
Dermal fillers
Minimally invasive procedures
Venipuncture
Can also be used for post procedural analgesia
Can be used to mitigate pain, itch and burn related to cutaneous manifestations of a variety of conditions
Safe and effective concentration of lidocaine HCl
Rapid onset of action
trans-dermal penetration/absorption enhanced
OTC
Affordable pricing
2. Our Mission
Sambria Pharmaceuticals is a developer of
differentiated, highly effective topical pain relief
consumer healthcare products and medications.
Our primary goals are to develop topical
formulations that provide clinicians, patients and
consumers with effective methods to mitigate
pain singularly or in conjunction with other
effective therapies in a regulatory compliant
manner.
Assist healthcare clinicians in improving patient
comfort, satisfaction and overall doctor/patient
experience
3. Our Approach
We have developed a proprietary topical pain relief
formula that combines the active ingredient,
lidocaine HCl with a blend of trans-dermal
penetration enhancers widely used in
pharmaceutical compounding.
Clinical applications of our launch product include
topical anesthesia particularly for the
dermatological, aesthetic/cosmetic, pediatric,
podiatric and other specialties where rapid onset of
local anesthesia is medically warranted and desired
Clinical studies being conducted around the globe
demonstrate the high degree of efficacy applying
transdermal delivery of topical lidocaine
applications in a safe manner when applied
responsibly.
4. Current and Potential
Applications
We are researching a broad range of current and potential future uses in
an effort to expand applications of this historically effective
anesthetic/analgesic.
Dermatologic conditions
Pre-and post-cosmetic/aesthetic procedure applications
Minor surgical procedures
IPL and LASER procedures
Venipuncture
Injections
Immunizations
Cutaneous allergy reactions
Pediatric
Neuropathic pain
Musculoskeletal pain
5. NeuroMed7TM
A topical anesthetic/analgesic cream that
combines the active ingredient lidocaine HCl 4%
with a proprietary blend of ingredients known in
pharmaceutical compounding to enhance
transdermal absorption of a variety of medicinal
therapies
In a topical cream formulation, lidocaine HCl 4% is
applied externally as a local analgesic/anesthetic
medication.
When used properly topical lidocaine
demonstrates a very low amount of lidocaine
entering the blood, limiting its systemic effects.
6. NeuroMed7TM
It can be used to reduce pain locally when applied externally directly to
the skin.
Typically will not cause profound, uncomfortable numbing of the skin
(lidocaine is known to cause numbing when applied by injection or to
mucous membranes),
However, its action is known to desensitize the affected area where
applied.
In combination with Sambria’s proprietary penetration enhancement
blend, NeuroMed7™ is demonstrating a rapid onset of action and
may serve physician needs for trans-dermal and sub-dermal
penetration
It is free of counter irritant materials sometimes known to cause localized
skin irritation. On the contrary its uses include relief from pain caused by
skin irritations.
This product is also free of topical acetaminophen or salicylates,
mitigating the risk of reactions in people with sensitivities to those
compounds.
7. Lidocaine HCL 4%
The active ingredient in NeuroMed7™ falls under a class of
medication known as OTC Topical Analgesics and
Anesthetics. See US FDA Monograph CFR 21 348 OTC Topical
Anesthetics and Analgesics
Medications in this class can be used for local pain relief
when applied externally.
When applied topically, Lidocaine HCl 4% has analgesic and
anesthetic properties.
In accordance with Federal Regulations, products in its
category can be used by children and adults 2 years of age
and older without prior consent of a licensed physician when
applied externally as an analgesic/anesthetic.
8. Product differentiators
Rapid onset of action (typically 3 to 5 minutes)
Proprietary blend that includes transdermal
penetration enhancers
Safe concentration of topical anesthetic –
lidocaine HCl 4%
Clinical use dose and patient retail size
packaging availability
Cost effective – affordable price points
throughout the distribution chain; from distributor
to end user
Co-branding
9. Facility Costs and Margins
Sambria wholesales its product for $17.50 per tube.
Tubes contain a blend of materials that include lidocaine HCl 4% in a
cream form. Tubes contain 2.2 ounces of cream per tube.
Tubes are sold wholesale in cases of 48 units per case. The case
Wholesale Acquisition Cost (WAC) is $840 per case ($17.50 per tube)
By special request, Sambria can package tubes in a 24 units case
box WAC is $445 per case ($18.54 per tube)
The manufacturer suggested retail price (MSRP) is $34.95 per tube.
When sold at the MSRP, Neuromed7™ has a nearly 100% markup.
Sambria also produces one use packaging for clinical setting
applications – Wholesale Acquisition Cost (WAC) is $1.70 per
application dose packet (package includes 3 milliliters of product– 1
milliliter = 40 mgs lidocaine HCl – total application per package = 120
mgs)
Clinic use individual packets are packaged in 100, 500, 1000 and
5000 unit boxes
10. Regulatory Compliance
NeuroMed7™ is manufactured and marketed in
accordance with United States Food and Drug
Administration (US FDA or FDA) regulations.
Regulation policies are governed by the US FDA
CFR 21 Monograph 348 OTC Topical Analgesic and
Anesthetics.
Monograph policy specifically directs marketers of
medications in this class to list the uses “topical
analgesic”, “topical anesthetic”, “external
analgesic”, “external anesthetic” or “for the
temporary relief of pain” on its product packaging.
¹ Monograph CFR 21 348.50(a).1
USA FDA NDC# 54723-175-22
11. Dermatological Safety and Efficacy
References Supporting the Use of OTC
4% Topical Lidocaine
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2923950/
http://www.the-dermatologist.com/article/7737
http://www.skinlaser.com/wp-
content/uploads/2011/07/2012AnestheticReviewDermSurg
-AlsterSobanko.pdf
http://www.hospitalpharmacyeurope.com/featured-
articles/topical-anaesthetics-dermatology
http://archderm.jamanetwork.com/article.aspx?articleid=
407139
http://www.drugs.com/cdi/lidocaine-cream.html
http://www.iacdworld.org/legal/lidocaine.htm
http://otcsafety.org/en/treatments/topical-pain-relievers/
http://www.webmd.com/drugs/mono-9170-LIDOCAINE+-
+TOPICAL.aspx?drugid=8532&drugname=Lidocaine+Top