|By Marketwired .||
|April 25, 2011 07:30 AM EDT||
NORTHBROOK, IL -- (Marketwire) -- 04/25/11 -- Horizon Pharma, Inc., a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved DUEXIS® (ibuprofen/famotidine), a novel tablet formulation containing a fixed-dose combination of ibuprofen (800 mg) and famotidine (26.6 mg). The FDA approval was supported by data from the pivotal REDUCE-1 and REDUCE-2 studies, which showed patients taking DUEXIS experienced significantly fewer upper gastrointestinal ulcers compared to patients receiving ibuprofen alone.
"We look forward to providing DUEXIS to the many patients suffering from osteoarthritis and rheumatoid arthritis, as it provides a new treatment option for those who may be at risk for upper gastrointestinal ulcers stemming from chronic NSAID use," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "The approval of DUEXIS is a transformative event for Horizon Pharma, representing our first U.S. approval. We would like to thank the patients and clinical investigators who participated in the pivotal REDUCE-1 and REDUCE-2 trials."
DUEXIS was studied in more than 1,500 patients with mild-to-moderate pain or arthritis. The primary endpoint of the REDUCE-1 study was the reduction in incidence of gastric ulcers during the six month treatment period. The primary endpoint of the REDUCE-2 study was the reduction in incidence of upper gastrointestinal (defined as gastric and/or duodenal) ulcers during the six month treatment period. In REDUCE-1, DUEXIS demonstrated a statistically significant reduction in the incidence of gastric ulcers versus treatment with ibuprofen alone (8.7% versus 17.6%). In REDUCE-2, DUEXIS demonstrated a statistically significant reduction in the incidence of upper gastrointestinal ulcers versus treatment with ibuprofen alone (10.5% versus 20.0%).
The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain and headache. Overall, the discontinuation rate in the REDUCE-1 and REDUCE-2 studies due to adverse events for patients receiving DUEXIS and ibuprofen alone were similar.
"The clinical data showed that DUEXIS helped reduce the incidence of upper gastrointestinal ulcers, which should be welcome news for physicians and patients concerned about the gastrointestinal impact of NSAID use," said Michael Schiff, M.D., Clinical Professor of Medicine at the University of Colorado School of Medicine, Rheumatology Division. "In my view, DUEXIS will allow more people access to the benefits of ibuprofen, while reducing the significant GI risk associated with its use."
Important Safety Information
Cardiovascular and Gastrointestinal Risks
- Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
- DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs, including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal (GI) adverse reactions including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.
DUEXIS should not be given to patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs have been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. DUEXIS is contraindicated in patients in late stages of pregnancy. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed.
When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn.
NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.
Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure.
Reports suggest that ibuprofen, a component of DUEXIS, may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking DUEXIS concomitantly with ACE-inhibitors.
As with other NSAIDs, the concurrent use of aspirin and DUEXIS may increase the risk of adverse events.
Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury.
If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur, DUEXIS should be discontinued.
Bleeding has been reported when ibuprofen and other NSAIDs have been administered to patients on coumarin-type anticoagulants, prescribers should be cautious when administering ibuprofen to patients on anticoagulants.
Please see Full Prescribing Information for DUEXIS at www.DUEXIS.com.
DUEXIS is a novel fixed-dose tablet combining the one of the world's most prescribed NSAIDs, ibuprofen, with the most potent H2-antagonist, famotidine (800 mg/26.6 mg), in a single pill. Ibuprofen has proven anti-inflammatory and analgesic properties, whereas famotidine reduces the stomach acid secretion that can cause gastric and duodenal ulceration. By combining ibuprofen and famotidine into a single product, it is believed that ibuprofen's gastrointestinal safety profile will be improved without altering its ability to reduce pain and inflammation.
DUEXIS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.
DUEXIS will be available to U.S. physicians in the second half of this year. For more information, including full prescribing information, please visit www.DUEXIS.com.
Horizon submitted a Marketing Authorization Application (MAA) to the European Medicines Association (EMA) for DUEXIS in October 2010.
About the Arthritis Market
Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. It is the most common form of arthritis and the most common cause of chronic pain, affecting more than 150 million individuals worldwide and 27 million Americans. OA is caused by various factors, including older age, being overweight, joint injury or stress, heredity and muscle weakness. OA commonly affects the hands, spine or large weight-bearing joints, such as the hips and knees.
Rheumatoid arthritis (RA) is a chronic disease, mainly characterized by inflammation of the lining, or synovium, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function and disability.
According to the Arthritis Foundation, a leading non-profit arthritis research advocacy group, arthritis affects nearly 46 million people in the U.S. With the aging of the U.S. population, the prevalence of arthritis is expected to rise by approximately 40% by 2030, impacting 67 million people in the U.S.
NSAIDs are very effective at providing pain relief associated with OA and RA; however, there are significant upper GI-associated adverse events which can result from such treatments. Significant GI side effects, including serious ulcers, afflict up to approximately 25 percent of all chronic arthritis patients treated with NSAIDs for three months, and OA and RA patients are two to five times more likely than the general population to be hospitalized for NSAID-related GI complications. It is estimated that NSAID-induced GI toxicity causes over 16,500 related deaths in OA and RA patients alone and over 107,000 hospitalizations for serious GI complications each year in the U.S.
About Horizon Pharma
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases. For more information, please visit www.horizonpharma.com.
Forward Looking Statements
This press release contains forward-looking statements regarding the potential for DUEXIS to treat osteoarthritis and rheumatoid arthritis and to reduce the risk of developing ibuprofen-induced gastrointestinal ulcers, the ability of DUEXIS to allow greater patient access to ibuprofen, and the timing of DUEXIS's availability to physicians. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, risks regarding the company's ability to commercialize products successfully, whether physicians will prescribe and patients will use DUEXIS, once available, and competition in the market for DUEXIS. For a further description of these and other risks facing the company, please see the risk factors described in the company's Registration Statement on Form S-1 that was originally filed with the United States Securities and Exchange Commission on August 3, 2010, and the amendments thereto, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to update or revise these statements, except as may be required by law.
Adobe is changing the world though digital experiences. Adobe helps customers develop and deliver high-impact experiences that differentiate brands, build loyalty, and drive revenue across every screen, including smartphones, computers, tablets and TVs. Adobe content solutions are used daily by millions of companies worldwide-from publishers and broadcasters, to enterprises, marketing agencies and household-name brands. Building on its established design leadership, Adobe enables customers not o...
Sep. 30, 2016 01:15 PM EDT Reads: 264
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Sep. 30, 2016 01:15 PM EDT Reads: 5,158
Information technology is an industry that has always experienced change, and the dramatic change sweeping across the industry today could not be truthfully described as the first time we've seen such widespread change impacting customer investments. However, the rate of the change, and the potential outcomes from today's digital transformation has the distinct potential to separate the industry into two camps: Organizations that see the change coming, embrace it, and successful leverage it; and...
Sep. 30, 2016 01:15 PM EDT Reads: 1,280
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Sep. 30, 2016 01:00 PM EDT Reads: 4,230
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Sep. 30, 2016 12:45 PM EDT Reads: 4,485
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Sep. 30, 2016 12:45 PM EDT Reads: 2,697
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Sep. 30, 2016 12:30 PM EDT Reads: 2,257
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Sep. 30, 2016 12:30 PM EDT Reads: 481
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
Sep. 30, 2016 12:30 PM EDT Reads: 3,265
“We're a global managed hosting provider. Our core customer set is a U.S.-based customer that is looking to go global,” explained Adam Rogers, Managing Director at ANEXIA, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Sep. 30, 2016 12:15 PM EDT Reads: 3,220
Apache Hadoop is a key technology for gaining business insights from your Big Data, but the penetration into enterprises is shockingly low. In fact, Apache Hadoop and Big Data proponents recognize that this technology has not yet achieved its game-changing business potential. In his session at 19th Cloud Expo, John Mertic, director of program management for ODPi at The Linux Foundation, will explain why this is, how we can work together as an open data community to increase adoption, and the i...
Sep. 30, 2016 12:00 PM EDT Reads: 1,205
"We have several customers now running private clouds. They're not as large as they should be but it's getting there. The adoption challenge has been pretty simple. Look at the world today of virtualization vs cloud," stated Nara Rajagopalan, CEO of Accelerite, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Sep. 30, 2016 12:00 PM EDT Reads: 2,520
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of (at least) three separate application components: the software embedded in the device, the back-end service, and the mobile application for the end user’s controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target –...
Sep. 30, 2016 11:15 AM EDT Reads: 1,569
What does it look like when you have access to cloud infrastructure and platform under the same roof? Let’s talk about the different layers of Technology as a Service: who cares, what runs where, and how does it all fit together. In his session at 18th Cloud Expo, Phil Jackson, Lead Technology Evangelist at SoftLayer, an IBM company, spoke about the picture being painted by IBM Cloud and how the tools being crafted can help fill the gaps in your IT infrastructure.
Sep. 30, 2016 11:15 AM EDT Reads: 3,093
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Sep. 30, 2016 11:00 AM EDT Reads: 557