Nuvo Research® Announces Scientific Presentations at Annual Painweek 2013 Meeting

  Nuvo Research® Announces Scientific Presentations at Annual Painweek 2013

PR Newswire

MISSISSAUGA, ON, Sept. 5, 2013

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

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

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  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

Forward-Looking Statements

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.


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