A Review of Topical Anesthetics for Superficial Dermatologic Procedures
Sambria_BLT Deck-032216
1.
2. • The NeuroMed “BLT” Analgesic Variety Pack is a combination
package of three individually wrapped topical, local, anesthetic
analgesics – benzocaine, lidocaine and tetracaine.
• Each individual anesthetic analgesic is provided in its own box and
packaged together for the convenience of the clinician.
• This unique comprehensive variety option has been created to allow
clinical flexibility beyond that of other single API topical anesthetic
analgesic options
3. 3 Boxes each of 25 single-use, sanitary packets per product:
• Benzocaine 20% / 25 – 3 ml packet (NeuroMed FA)
• Lidocaine 4% / 25 – 4 ml packet (NeuroMed 7)
• Tetracaine 2% / 25 – 3 ml packet (NeuroMed LA)
4.
5. • All include the standard Sambria Pharmaceuticals’ proprietary
formulation designed to improve delivery and rate of onset of the
active pharmaceutical ingredients (API’s) – the key technology used
to create stark product differentiation.
• Each type of anesthetic analgesic is packaged separately in individual
3-ml packets (4-ml for lidocaine). Each anesthetic analgesic is packaged
in boxes of 25 units per box for a total combined 250 grams of product.
• All three boxes are wrapped in a single, combination variety
package for clinician convenience and ease of shipping.
6. • Clinicians are provided with the option of choosing the appropriate
anesthetic analgesic commensurate with specific applicable uses.
• This combination variety package also provides three individual API’s
which allow clinicians to use singly or otherwise as deemed medically
necessary at clinician discretion
• For additional convenience, each individual 3-milliliter sanitary,
single-use packet (lidocaine – 4-ml) is supplied as a metered dose
application for dosing precision and wastage minimization.
7. • Sanitary dose packaging
• Precision metered dose packaging – limited waste
• Formulated to improve onset and efficacy
• Modular multiple options – fast-acting to long-lasting depending
on anesthetic analgesic application
• Increased therapeutic flexibility
• Designed to improve safety profile (in IRB approved study of the
lidocaine product – among 239 human test subjects none demonstrated
plasma lidocaine in the blood up to 12 hours after initial application)
• Cost-effective - competitively priced
(MSRP - only $0.80 per gram to clinical customer)
8. Samples packets are supplied three to a stip. Each strip has a perforation
in between to separate one from the other. Each individual packet includes
its own specific data box on the back of the package. The three combined
packets have a single tear off tab at the top for easy access and administration.
9. • Lidocaine-containing products play an integral role in cutaneous anesthesia by providing patient
comfort with minimal side effects. Careful attention must be paid to the particular anatomic
location, the total surface area covered, and the duration of anesthetic skin contact
• By reducing the duration of anesthetic contact with skin, clinicians can potentially decrease the risk
of cumulative anesthetic dose entry into the blood – NeuroMed brand topical anesthetics repeatedly
demonstrate reduced time to onset and peak action anecdotally
• This variety package has the potential to provide a strong solution to the regulatory obstacles
currently presented by the uniformly non-compliant vast pharmaceutical compounding marketplace
(in particular, anticipatory compounding and widespread clinician diversion)
• Sambria Pharmaceuticals is the first to market a comprehensive multi-API solution
in a regulatory compliant manner
• In the event clinicians choose to combine all three API’s, it is highly unlikely that any single
API product will match efficacy. Clinicians should take into consideration the total anesthetic
dose in the event it is deemed medically necessary to combine two or more API’s. IRB approved
study of the lidocaine product presented no active lidocaine nor its primary metabolite MEGX found
in blood samplings among 239 human test subjects when drawn at multiple intervals
• Unique metered dosed, sanitary packaging also provides for wastage minimization as well as more
precise dosing when compared to tube or jar packaging
10. Products are regulated by, marketed and manufactured in accordance
with the 21 CFR 348 Monograph OTC Topical Analgesics and Anesthetics.
