- Mallinckrodt to Launch PENNSAID 2% in the U.S. in Q1 2014 -
MISSISSAUGA, ON, Jan. 17, 2014 /CNW/ - 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 |
-- PENNSAID is also contraindicated in patients:
o with a known hypersensitivity to diclofenac sodium or any other
component of PENNSAID
o 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
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
-- 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
-- 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
-- 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
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.
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.
Christina Cameron Director, Investor Relations & Corporate Communications
Email:firstname.lastname@example.org Tel: +1 (905) 673-3617
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