Nuvo announces Mallinckrodt submits PK study report in response to PENNSAID®
2% FDA complete response letter
MISSISSAUGA, ON, Aug. 15, 2013
MISSISSAUGA, ON, Aug. 15, 2013 /PRNewswire/ - Nuvo Research Inc. (Nuvo)
(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 today announced that its U.S.
licensing partner for PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w
and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt
(NYSE:MNK) has submitted the results of a pharmacokinetic (PK) study to the
U.S. Food and Drug Administration (FDA) in support of its New Drug Application
for PENNSAID 2%.
On March 4, 2013, Mallinckrodt received a Complete Response Letter (CRL) from
the FDA following the review of Mallinckrodt's New Drug Application for
PENNSAID 2%. In the CRL, the FDA required that Mallinckrodt complete a PK
study comparing PENNSAID 2% to original PENNSAID. Mallinckrodt completed the
PK study and on August 7, 2013 submitted the clinical study report to the
FDA. The FDA is expected to advise Mallinckrodt if the resubmission is
acceptable for review within 14 days of the filing and to provide a formal
response to Mallinckrodt within 6 months of the filing.
PENNSAID is a non-steroidal anti-inflammatory drug (NSAID) used for treating
the signs and symptoms of osteoarthritis of the knee(s).
PENNSAID 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
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 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. It is more viscous
than original PENNSAID, is supplied in a metered dose pump bottle and was
studied in clinical trials using twice daily dosing compared to four times a
day for original PENNSAID.
About Nuvo Research Inc.
Nuvo is a publicly traded, Canadian specialty pharmaceutical company,
headquartered in Mississauga, Ontario. The Company is building a portfolio of
products for the treatment of pain through internal research and development.
The Company's product portfolio includes Pennsaid^®, Pliaglis and a heated
lidocaine/tetracaine patch (HLT patch). Pennsaid, a topical non-steroidal
anti-inflammatory drug (NSAID), is used to treat the signs and symptoms of
osteoarthritis of the knee(s). Pennsaid is sold in the U.S. by Mallinckrodt
Inc. in Canada by Paladin Labs Inc. and in several European countries.
Pliaglis is a topical local anesthetic cream which provides topical local
analgesia for superficial dermatological procedures. The Company has licensed
worldwide marketing rights to Pliaglis to Galderma Pharma S.A., a global
pharmaceutical company specialized in dermatology. Galderma launched the
marketing and sale of Pliaglis in the U.S. in March of 2013 and in the E.U. in
April of 2013. The HLT patch is a topical patch that combines lidocaine,
tetracaine and heat and is approved in the U.S. to provide local dermal
analgesia for superficial venous access and superficial dermatological
procedures and in Europe, for surface anaesthesia of normal intact skin.
Nuvo's licensing partner, Galen US Incorporated markets the HLT patch (under
the name Synera) in the U.S. In Europe, Nuvo's licensing partner, Eurocept
International B.V., has initiated a pan-European launch of the HLT patch
(under the name Rapydan). The Company is also developing WF10, for the
treatment of immune related diseases.
Further information on Nuvo Research is available on the company's website
www.nuvoresearch.com or by contacting:
Investor Relations Email: firstname.lastname@example.org
PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w
INDICATIONS AND USAGE
PENNSAID^® (diclofenac sodium topical solution) 1.5% w/w is a nonsteroidal
anti-inflammatory drug (NSAID) indicated for the treatment of signs and
symptoms of osteoarthritis of the knee(s).
IMPORTANT RISK INFORMATION
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL 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.
*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.
*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
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
*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.
*Do not apply to open wounds. 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. Avoid contact
of PENNSAID with eyes and mucous membranes. Wash and dry hands after use.
Concurrent use with oral NSAIDs should be avoided unless benefit outweighs
risk and periodic laboratory evaluations are conducted
*The most common treatment-related adverse events in patients receiving
PENNSAID 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.
See Full Prescribing Information for additional Important Risk Information.
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.
Nuvo Research Inc.
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