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Sr. Executive / Executive, Production; THE IBN SINA PHARMACEUTICAL IND LTD

 
Approval of Duexis Tablets (famotidine and ibuprofen) by FDA
Brand Name: Duexis Tablets
Generic Name: famotidine and ibuprofen
Company Name: Horizon Pharma, Inc.
Date of Approval: April 23, 2011
Treatmant for: Osteoarthritis, Rheumatoid Arthritis, NSAID-Induced Ulcer Prophylaxis
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.
Note: To know more please go to the following sources.
Update: 2011-04-25
Source: Drugs.com & FDA
 
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