Welcome!

News Feed Item

Nuvo Research Announces the U.S. Commercial Launch of PENNSAID® 2% by Mallinckrodt

MISSISSAUGA, ON, Feb. 10, 2014 /PRNewswire/ - Nuvo Research Inc. (TSX: NRI), a specialty pharmaceutical company with a diverse portfolio of topical and immunology products today announced the U.S. commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%) by its U.S. commercial licensee Mallinckrodt (NYSE:MNK).  PENNSAID 2% is the first twice per day topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the United States for the treatment of the pain of osteoarthritis of the knee(s).  Nuvo receives royalties on U.S. sales of PENNSAID 2%.

"We believe the commercial launch of PENNSAID 2% has the potential to generate increased sales from which Nuvo can receive increased royalties," said Dan Chicoine, Chairman and co-CEO.  "PENNSAID 2% provides a topical treatment option to the millions of U.S. patients suffering from the pain of osteoarthritis of the knee while providing a lower systemic drug exposure than an oral NSAID."

PENNSAID 2% was approved by the U.S. Food and Drug Administration on January 16, 2014.  U.S. sales and marketing rights for PENNSAID 2% are licensed to Mallinckrodt by Nuvo Research Inc.

About PENNSAID 2%
PENNSAID 2% is a follow-on product to original PENNSAID (diclofenac sodium topical solution) 1.5% w/w (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 topical and immunology products.

Nuvo's marketed products include PENNSAID 1.5% (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.

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

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 membranes
  • PENNSAID was not evaluated under the conditions of heat application, occlusive dressings overlay, or exercise; therefore, concurrent use of PENNSAID under these conditions is not recommended.
  • Do not:
    • apply PENNSAID to open wounds.
    • shower for at least 30 minutes after applying PENNSAID.
    • 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 2% 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 2% 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.

Click here for Full Prescribing Information for additional Important Risk Information including boxed warning.

PENNSAID is a registered trademark of Nuvo Research Inc.

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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
The question before companies today is not whether to become intelligent, it’s a question of how and how fast. The key is to adopt and deploy an intelligent application strategy while simultaneously preparing to scale that intelligence. In her session at 21st Cloud Expo, Sangeeta Chakraborty, Chief Customer Officer at Ayasdi, provided a tactical framework to become a truly intelligent enterprise, including how to identify the right applications for AI, how to build a Center of Excellence to oper...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
High-velocity engineering teams are applying not only continuous delivery processes, but also lessons in experimentation from established leaders like Amazon, Netflix, and Facebook. These companies have made experimentation a foundation for their release processes, allowing them to try out major feature releases and redesigns within smaller groups before making them broadly available. In his session at 21st Cloud Expo, Brian Lucas, Senior Staff Engineer at Optimizely, discussed how by using ne...
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"CA has been doing a lot of things in the area of DevOps. Now we have a complete set of tool sets in order to enable customers to go all the way from planning to development to testing down to release into the operations," explained Aruna Ravichandran, Vice President of Global Marketing and Strategy at CA Technologies, in this SYS-CON.tv interview at DevOps Summit at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
In his session at 21st Cloud Expo, James Henry, Co-CEO/CTO of Calgary Scientific Inc., introduced you to the challenges, solutions and benefits of training AI systems to solve visual problems with an emphasis on improving AIs with continuous training in the field. He explored applications in several industries and discussed technologies that allow the deployment of advanced visualization solutions to the cloud.
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Agile has finally jumped the technology shark, expanding outside the software world. Enterprises are now increasingly adopting Agile practices across their organizations in order to successfully navigate the disruptive waters that threaten to drown them. In our quest for establishing change as a core competency in our organizations, this business-centric notion of Agile is an essential component of Agile Digital Transformation. In the years since the publication of the Agile Manifesto, the conn...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
Vulnerability management is vital for large companies that need to secure containers across thousands of hosts, but many struggle to understand how exposed they are when they discover a new high security vulnerability. In his session at 21st Cloud Expo, John Morello, CTO of Twistlock, addressed this pressing concern by introducing the concept of the “Vulnerability Risk Tree API,” which brings all the data together in a simple REST endpoint, allowing companies to easily grasp the severity of the ...
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...
While some developers care passionately about how data centers and clouds are architected, for most, it is only the end result that matters. To the majority of companies, technology exists to solve a business problem, and only delivers value when it is solving that problem. 2017 brings the mainstream adoption of containers for production workloads. In his session at 21st Cloud Expo, Ben McCormack, VP of Operations at Evernote, discussed how data centers of the future will be managed, how the p...