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).
Study 1
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 Park,
KS.
Study 2
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 patients.
"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.
Study 3
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 functional
improvement.
"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.
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SOURCE Nuvo Research Inc.