Horizon Pharma, Inc announced that DUEXIS
(ibuprofen/famotidine), a proprietary single-tablet combination of ibuprofen
(800 mg) and famotidine (26.6 mg), is now available to U.S. physicians for the
relief of signs and symptoms of rheumatoid arthritis (RA) and osteoarthritis
(OA) and to decrease the risk of developing upper gastrointestinal (GI) ulcers,
which in Phase 3 clinical trials were 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 ulcers. Controlled trials do not extend beyond six
months.
In April, the U.S. Food and Drug Administration (FDA) approved Horizon's new drug application (NDA) for DUEXIS. The NDA was supported by data from the pivotal REDUCE-1 and REDUCE-2 clinical studies that enrolled more than 1,500 patients. In REDUCE-1, DUEXIS demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced 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.
According to the Arthritis Foundation, arthritis affects nearly 46 million people in the United States. 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 United States.
NSAIDs are 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. DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by approximately 50% in REDUCE-1 and REDUCE-2. Patients with OA and RA on NSAIDs are at increased risk for upper GI ulcers.
In April, the U.S. Food and Drug Administration (FDA) approved Horizon's new drug application (NDA) for DUEXIS. The NDA was supported by data from the pivotal REDUCE-1 and REDUCE-2 clinical studies that enrolled more than 1,500 patients. In REDUCE-1, DUEXIS demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced 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.
According to the Arthritis Foundation, arthritis affects nearly 46 million people in the United States. 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 United States.
NSAIDs are 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. DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by approximately 50% in REDUCE-1 and REDUCE-2. Patients with OA and RA on NSAIDs are at increased risk for upper GI ulcers.
People like this seriously bother me. I have multiple food allergies, several of which are life-threatening.
ReplyDeleteIbuprofen
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