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Nuvo Research Announces FDA Approval of PENNSAID® 2%



             Nuvo Research Announces FDA Approval of PENNSAID® 2%

PR Newswire

MISSISSAUGA, ON, Jan. 17, 2014

- Mallinckrodt to Launch PENNSAID 2% in the U.S. in Q1 2014 -

MISSISSAUGA, ON, Jan. 17, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX:NRI), a
specialty pharmaceutical company with a diverse portfolio of products in the
areas of topical pain and immunology today announced that the U.S. Food and
Drug Administration (FDA) has approved Mallinckrodt's New Drug Application for
PENNSAID^® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).

PENNSAID 2% is  a follow-on  product to original  PENNSAID (diclofenac  sodium 
topical solution)  1.5%  w/w  (PENNSAID  1.5%)  which  has  been  marketed  by 
Mallinckrodt in the U.S. since 2010. PENNSAID  2% will be the first twice  per 
day dosed topical NSAID available in the U.S. for the treatment of the pain of
osteoarthritis of the  knee. Nuvo has  licensed the U.S.  sales and  marketing 
rights for both PENNSAID 1.5% and PENNSAID 2% to Mallinckrodt.

"The approval of PENNSAID  2% is a significant  milestone for Nuvo," said  Dan 
Chicoine, Chairman and Co-Chief  Executive Officer of  Nuvo Research. "We  are 
pleased that the FDA has approved this product for patients suffering from the
pain of osteoarthritis of the knee."

PENNSAID (diclofenac sodium topical solution) 2% w/w

INDICATIONS AND USAGE

PENNSAID (diclofenac sodium topical solution) 2% w/w is a nonsteroidal
anti-inflammatory drug (NSAID) indicated for the treatment of pain of
osteoarthritis of the knee(s).

IMPORTANT RISK INFORMATION

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
Cardiovascular Risk

  * Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk
    of serious cardiovascular thrombotic events, myocardial infarction, and
    stroke, which can be fatal. This risk may increase with duration of use.
    Patients with cardiovascular disease or risk factors for cardiovascular
    disease may be at greater risk.
  * PENNSAID is contraindicated in the perioperative setting of coronary
    artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  * NSAIDs cause an increased risk of serious gastrointestinal adverse events
    including bleeding, ulceration, and perforation of the stomach or
    intestines, which can be fatal. These events can occur at any time during
    use and without warning symptoms. Elderly patients are at greater risk for
    serious gastrointestinal events.

CONTRAINDICATIONS

  * PENNSAID is also contraindicated in patients:

       * with a known hypersensitivity to diclofenac sodium or any other
         component of PENNSAID
       * who have experienced asthma, urticaria, or allergic-type reactions
         after taking aspirin or other NSAIDs. Severe, rarely fatal
         anaphylactic-like reactions to NSAIDs have been reported in such
         patients

WARNINGS AND PRECAUTIONS

  * Elevation of one or more liver tests may occur during therapy with NSAIDs.
    PENNSAID should be discontinued immediately if abnormal liver tests
    persist or worsen.
  * Use with caution in patients with fluid retention or heart failure.
    Hypertension can occur with NSAID treatment. Monitor blood pressure
    closely with PENNSAID treatment.
  * Long-term administration of NSAIDs can result in renal papillary necrosis
    and other renal injury. Use PENNSAID with caution in patients at greatest
    risk of this reaction, including the elderly, those with impaired renal
    function, heart failure, liver dysfunction, and those taking diuretics and
    ACE-inhibitors.
  * Anaphylactoid reactions may occur in patients without prior exposure to
    PENNSAID. NSAIDs can cause serious skin adverse events such as exfoliative
    dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis
    (TEN), which can be fatal.
  * Wash and dry hands before and after use. Avoid contact of PENNSAID with
    the eyes and mucous membrane.
  * Do not:

               apply PENNSAID to open wounds
               shower for at least 30 minutes after applying PENNSAID
               apply external heat and/or occlusive dressings to treated
knees 
               wear clothing over the PENNSAID treated knee until the treated
knee is dry

  * Protect treated knee(s) from natural or artificial sunlight. Topicals,
    such as sunscreen and bug repellent, may be applied after PENNSAID treated
    knee(s) are completely dry.
  * Concurrent use with oral NSAIDs should be avoided unless benefit outweighs
    risk and periodic laboratory evaluations are conducted.

ADVERSE REACTIONS

  * The most common adverse events in a phase 2 clinical trial of PENNSAID
    were application site reactions, such as dryness (22%), exfoliation (7%),
    erythema (4%), pruritus (2%), pain (2%), induration (2%), rash (2%), and
    scabbing (1%). Other adverse reactions occurring in >1% of patients
    receiving PENNSAID included urinary tract infection (3%), contusion (2%),
    sinus congestion (2%), and nausea (2%).
  * The most common treatment-related adverse events in patients receiving
    PENNSAID 1.5% were application site skin reactions including dry skin
    (32%), contact dermatitis characterized by skin erythema and induration
    (9%), contact dermatitis with vesicles (2%) and pruritus (4%). In a long
    term safety study, contact dermatitis occurred in 13% and contact
    dermatitis with vesicles in 10% of patients, generally within the first 6
    months of exposure, leading to a withdrawal rate for an application site
    event of 14%. Other common adverse events greater than placebo include:
    dyspepsia (9%), abdominal pain (6%), flatulence (4%), diarrhea (4%) and
    nausea (4%).

USE IN SPECIFIC POPULATIONS

  * PENNSAID should not be used in pregnant or lactating women and is not
    approved for use in pediatric patients.

About PENNSAID 1.5%

PENNSAID 1.5%  is  a non-steroidal  anti-inflammatory  drug (NSAID)  used  for 
treating the signs and symptoms of osteoarthritis of the knee(s).

PENNSAID 1.5% is the only FDA-approved topical NSAID for the treatment of knee
osteoarthritis which demonstrated statistically significant differences in all
three primary efficacy endpoints: pain and physical function (WOMAC),  patient 
overall health  assessment  (POHA),  and patient  global  assessment  of  knee 
osteoarthritis.

PENNSAID is a registered trademark of Nuvo Research Inc.

WOMAC is a registered trademark of Nicholas Bellamy.

WOMAC is a proprietary health  status questionnaire.  For further  information 
visit the WOMAC^® website at www.WOMAC.com.

About PENNSAID 2%

PENNSAID 2%  is  a  follow-on  product to  original  PENNSAID  1.5%  which  is 
currently marketed  in the  U.S.  by Mallinckrodt  under license  from  Nuvo.  
PENNSAID  2%  is  a  topical  non-steroidal  anti-inflammatory  drug   (NSAID) 
containing 2% diclofenac sodium compared to 1.5% for original PENNSAID  1.5%.  
It is more viscous than original PENNSAID 1.5%, is supplied in a metered  dose 
pump bottle and  has been  approved for twice  daily dosing  compared to  four 
times a day for original PENNSAID 1.5%.

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), PENNSAID 2% (a topical  treatment 
for the  pain  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.

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.

Contact:

Christina Cameron
Director, Investor Relations & Corporate Communications
Email: ccameron@nuvoresearch.com
Tel: +1 (905) 673-3617
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