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Horizon Pharma plc Announces DUEXIS(R) Selected as Winner of Chicago Innovation Award


October 31, 2014 - Chicago, IL

Horizon Pharma plc (NASDAQ: HZNP), a specialty biopharmaceutical company with a portfolio of products in arthritis, inflammation and orphan diseases, today announced that DUEXIS® (ibuprofen/famotidine) has been selected as one of the winners of the 13th annual Chicago Innovation Awards. Last night at Chicago's Harris Theater, Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma, received the award with nearly 1,500 business and civic leaders in attendance. The Chicago Innovation Awards, celebrating its 13th year, recognizes the most innovative new products or services brought to market or to public service each year.

"With a large percentage of the approximately 50 million individuals suffering from arthritis in the United States taking prescription-strength nonsteroidal anti-inflammatory drugs, or NSAIDs, and therefore at risk of developing gastrointestinal (GI) ulcers, Horizon Pharma developed DUEXIS, an innovative combination of ibuprofen and famotidine, that reduces pain and inflammation while reducing the risk of developing GI ulcers," said Tom Kuczmarski, co-founder of the Chicago Innovation Awards. "Horizon Pharma's product DUEXIS shows how innovation can be simple and clever yet profoundly impactful."

For the first time in the NSAID market, Horizon Pharma developed a product-DUEXIS-that combined prescription-strength ibuprofen with high-dose famotidine to address pain and inflammation associated with osteoarthritis (OA) and rheumatoid arthritis (RA) and to reduce the development of GI ulcers due to the NSAID component ibuprofen. Ibuprofen is the most prescribed NSAID in the United States. By combining high-dose prescription-strength famotidine along with prescription strength ibuprofen in one tablet, Horizon Pharma has enabled patients to reduce their arthritis pain and inflammation while reducing the risk of developing GI ulcers associated with taking ibuprofen alone.

"On behalf of my colleagues at Horizon Pharma, I am honored to receive the Chicago Innovation Award for our work with DUEXIS," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "Our focus is to improve patients' lives by commercializing products that address unmet needs and DUEXIS was the first product we introduced. We are thrilled to be recognized for our work in helping individuals living with OA and RA to better manage their pain and inflammation while reducing their risk of developing GI ulcers."

About DUEXIS

DUEXIS, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, 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. For more information, please visit www.DUEXIS.com.

The following details are from the DUEXIS (ibuprofen and famotidine) Prescribing Information. For more information, please see the Medication Guide and the full Prescribing Information for DUEXIS available at www.DUEXIS.com. Always talk with your health care provider if you have questions.

Approved Uses for DUEXIS

DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, 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.

Important Safety Information

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, may increase the chance of a heart attack or stroke, which can be fatal. This chance increases with longer use and in people who have heart disease or risk factors for heart disease
  • DUEXIS should not be used before or after a type of heart surgery called coronary artery bypass graft (CABG)
  • NSAID-containing medications like DUEXIS may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer. These problems can happen without warning and can lead to death. Older patients may have a greater chance of developing these problems

DUEXIS is not right for everyone. People who have had asthma, hives or an allergic reaction to aspirin or other NSAIDs should not take DUEXIS. Women in the late stages of pregnancy should not take DUEXIS. People who have had allergic reactions to medications like famotidine (histamine H2-receptor antagonists) should not take DUEXIS.

Tell your health care provider right away if you have signs of active bleeding (persistent and unexplained) while you are taking DUEXIS.

NSAID-containing medications like DUEXIS can cause high blood pressure or make existing high blood pressure worse, either of which can increase the chance of a heart attack or stroke. Your health care provider should check your blood pressure while you are taking DUEXIS.

Before you start taking DUEXIS, tell your health care provider if you have heart problems, kidney problems or liver problems or if you are taking medications for high blood pressure. DUEXIS can increase the chance of potentially significant liver injury and/or kidney injury, which may be fatal. Stop taking DUEXIS immediately and contact your health care provider if you experience any signs and/or symptoms of liver or kidney injury.

Serious allergic reactions, including skin reactions, can happen without warning and can be life threatening. Stop taking DUEXIS and consult your doctor immediately if you get a skin rash or if you start to have problems breathing or swallowing, or if you develop swelling of your face or throat.

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain and headache.

About Horizon Pharma plc

Horizon Pharma plc (NASDAQ: HZNP) is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated products that address unmet medical needs. The Company markets a portfolio of products in arthritis, inflammation and orphan diseases. Horizon's U.S. marketed products are ACTIMMUNE® (interferon gamma-1b), DUEXIS® (ibuprofen/famotidine), RAYOS® (prednisone) delayed-release tablets and VIMOVO® (naproxen/esomeprazole). Beginning in January 2015, the Company will also begin marketing PENNSAID® (diclofenac sodium topical solution) 2% w/w in the U.S. Horizon's global headquarters are in Dublin, Ireland. For more information, please visit www.horizonpharma.com.

Media and Investor Contact:
Elizabeth M. Higashi, CFA
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