Data Evaluating Heated Lidocaine/Tetracaine Patch for the Treatment of
Acute Musculoskeletal Pain to be Presented
MISSISSAUGA, ON, Sept. 5, 2013 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a
specialty pharmaceutical company dedicated to building a portfolio of
products for the topical treatment of pain and the development of its
immune modulating drug candidate WF10 announced today that researchers
are presenting scientific data related to the heated
lidocaine/tetracaine patch (HLT Patch) (70 mg lidocaine/ 70 mg
tetracaine) at PAINWeek 2013, to be held September 4-7 in Las Vegas.
The current marketed version of the HLT Patch, known as the Synera
Patch, is FDA approved for use on intact skin to provide local dermal
analgesia for superficial venous access and superficial dermatological
procedures such as excision, electrodessication and shave biopsy of
skin lesions. The Synera Patch is currently marketed in the United
States by Nuvo's exclusive licensing partner for the current approved
indication, Galen US Incorporated (Galen).
The HLT Patch is being developed by Nuvo for the treatment of acute
musculoskeletal pain (AMP).
The study in the first poster was conducted to compare 2 different
dosing application regimens of the HLT Patch (twice daily and once
daily application) and oral naproxen for the treatment of pain
associated with lateral epicondylitis (tennis elbow) in a 4-week
open-label study that enrolled 52 adult subjects. After 2 weeks of
treatment, clinically important reduction in average pain scores
(defined as 30% reduction from baseline) were experienced by more
patients treated with the HLT Patch 4 hr BID (56%) and the HLT Patch 12
hr QD (53%) than by patients treated with oral naproxen (41%).
Application site rash or erythema was reported by 50% of patients in
the HLT Patch twice daily application group and 18% of patients in the
HLT Patch once daily application group. Two patients in the HLT Patch
twice daily application group withdrew from the study due to
application site adverse events. Two patients in oral naproxen group
experienced nausea as an adverse event.
"In this study the HLT Patch administered once or twice daily for pain
of lateral epicondylitis resulted in the majority of patients
experiencing clinically meaningful reductions in pain comparable to
that seen with oral naproxen. The HLT Patch may offer a novel
significant clinical option by providing a locally targeted treatment
which minimizes the risks of systemic adverse effects for patients with
tennis elbow pain," said Srinivas Nalamachu, MD, principal
investigator, International Clinical Research Institute Inc., Overland
The study in the second poster compared the efficacy of the HLT Patch vs
a single corticosteroid injection for the treatment of shoulder
impingement syndrome (SIS) pain in a 6-week, randomized, open-label
study which enrolled 60 adult subjects. Both groups demonstrated a
significant (P<.001) reduction in average pain scores at 2 weeks
compared with baseline (-35%±29% and -42%±36% in the HLT Patch and
injection groups, respectively), which were sustained through 6 weeks
(-43%±34% and -43%±41%, respectively). Significant improvements in
shoulder range of motion were also seen in both treatment groups by
treatment week 2 and sustained throughout the entire 6 week study.
Mild to moderate application site erythema was the most common
treatment related adverse event observed in 22 of 29 HLT Patch
"In this study, the HLT Patch provided similar degrees of improvement in
both pain and range of motion, when compared to the current
gold-standard treatment of steroid injection. Being able to treat
shoulder impingement effectively, while avoiding the potential problems
of steroids and injections, is a significant clinical advantage," said
Richard Radnovich, D.O., principle investigator, Injury Care Medical
Center, Boise, Idaho.
The third poster will be presenting a pooled analysis that examined the
relationship between decreased pain scores and improved function in 73
subjects treated with HLT Patch in four open-label pilot studies for
AMP associated with SIS, patellar tendinopathy, carpal tunnel syndrome
and myofascial trigger points. Approximately one third of patients
treated with the HLT Patch achieved a 50% reduction in average pain
scores, which was also associated with 1.5- to 2-fold greater
"A number of recent publications have suggested that a 50% or greater
improvement in pain be considered as "substantial." Here we see that
this level of pain improvement is associated with a twofold greater
degree of functional improvement underscoring this as an important
measure of a treatment's effectiveness," said Arnold Gammaitoni,
Pharm.D., Vice President, Scientific Affairs at Nuvo.
Important Risk Information for the current marketed formulation
In clinical studies with the current marketed formulation, the most
common skin reactions were generally mild application site reactions
such as redness, blanching, and swelling. Allergic reactions such as
hives, difficulty breathing, skin redness or swelling, and shock can
occur. The Synera Patch should be stored and disposed out of their
reach since large amounts of lidocaine and tetracaine remain in the
patch and can be harmful to children or pets.
The current formulation is contraindicated in patients with a known
history of sensitivity to lidocaine, tetracaine, or local anesthetics
of the amide or ester type. The current formulation is also
contraindicated in patients with para-aminobenzoic acid (PABA)
hypersensitivity and in patients with a known history of sensitivity to
any other component of the product. See Full Prescribing Information for the current formulation at www.synera.com for additional Important Risk Information.
About Nuvo Research Inc.
Nuvo (TSX:NRI) is a specialty pharmaceutical company focused on
improving patient's lives by developing and commercializing innovative
products that address unmet medical needs. The Company has a diverse
portfolio of products in the areas of topical pain and immunology.
Nuvo's marketed products include Pennsaid® (a topical treatment for the signs and symptoms of osteoarthritis of
the knee), Pliaglis (a topical local anesthetic) and the heated
lidocaine/tetracaine patch (HLT Patch). For additional Company
information visit www.nuvoresearch.com.
Certain statements in this news release constitute forward-looking
statements within the meaning of applicable securities laws.
Forward-looking statements include, but are not limited to, statements
concerning the Company's future objectives, strategies to achieve those
objectives, as well as statements with respect to management's beliefs,
plans, estimates, and intentions, and similar statements concerning
anticipated future events, results, circumstances, performance or
expectations that are not historical facts. Forward-looking statements
generally can be identified by the use of forward-looking terminology
such as "outlook", "objective", "may", "will", "expect", "intend",
"estimate", "anticipate", "believe", "should", "plans" or "continue",
or similar expressions suggesting future outcomes or events. Such
forward-looking statements reflect management's current beliefs and are
based on information currently available to management.
Forward-looking statements involve risks and uncertainties that could
cause actual results to differ materially from those contemplated by
such statements. Factors that could cause such differences include the
need for additional financing, the current economic environment,
dependence on sales and marketing partnerships, competitive
developments, as well as other risk factors included in the Company's
annual information form dated March 27, 2013 under the heading "Risks
Factors" and as described from time to time in the reports and
disclosure documents filed by the Company with Canadian securities
regulatory agencies and commissions. This list is not exhaustive of
the factors that may impact the Company's forward-looking statements.
These and other factors should be considered carefully and readers
should not place undue reliance on the Company's forward-looking
statements. As a result of the foregoing and other factors, no
assurance can be given as to any such future results, levels of
activity or achievements and neither the Company nor any other person
assumes responsibility for the accuracy and completeness of these
forward-looking statements. The factors underlying current
expectations are dynamic and subject to change. Although the
forward-looking information contained in this news release is based
upon what management believes are reasonable assumptions, there can be
no assurance that actual results will be consistent with these
forward-looking statements. Certain statements included in this news
release may be considered "financial outlook" for purposes of
applicable securities laws, and such financial outlook may not be
appropriate for purposes other than this news release. All
forward-looking statements in this news release are qualified by these
cautionary statements. The forward-looking statements contained herein
are made as of the date of this news release and except as required by
applicable law, the Company undertakes no obligation to publicly update
or revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
SOURCE Nuvo Research Inc.