Wednesday, June 1, 2011

Jun2011 – Pain Product Announcements & Warnings

Announcements Featured Items: ibuprofen and famotidine tablets (Duexis) approved; Bayer advanced aspirin available; intranasal ketorolac (Sprix Nasal Spray) now available — All brand names are trademarks of their respective manufacturers. Compiled by Winnie Dawson, MA, RN, BSN.

Ibuprofen and Famotidine Tablets (Duexis®) — FDA Approved
Horizon Pharma, Inc. received an April 2011 U.S. Food and Drug Administration approval for their novel fixed-dose formulation of ibuprofen 800 mg and famotidine 26.6 mg, a histamine H2-receptor antagonist used to inhibit stomach acid production. The product was approved to treat the signs and symptoms of rheumatoid arthritis and osteoarthritis while providing a potential reduction in the risk of NSAID-induced upper gastrointestinal ulcers. The approval decision was based on the results of 2 clinical trials that studied more than 1,500 patients with mild-to-moderate chronic pain or arthritis. Both studies reported a statistically significant reduction in the incidence of gastric ulcers in the treatment group compared to the ibuprofen-only group. The most frequently reported adverse effects were nausea, dyspepsia, diarrhea, constipation, and headache. Significantly fewer study participants in the treatment group withdrew from the study early when compared with those taking ibuprofen alone. Patients who have a history of allergic reactions after taking aspirin or other NSAIDs should not take Duexis. See the [medication guide] and [prescribing information] for full administration and safety recommendations.

Bayer® Advanced Aspirin — Now Available
Bayer HealthCare introduced Bayer Advanced Aspirin in two non-prescription tablet strengths — Regular and Extra Strength doses are 325 mg and 500 mg, respectively. This new fast-acting product line uses a Pro-Release™ formulation of micro-particles that dissolve faster because they are about 90% smaller than the aspirin particles in a standard tablet. Clinical studies showed that Bayer Advanced Aspirin brought meaningful pain relief about twice as fast as a standard aspirin tablet. People who are taking an anticoagulant or steroid drug, have a history of allergic reaction to aspirin or other NSAIDs, have stomach ulcers, or consume more than 3 alcoholic drinks daily, should talk with their healthcare professional before using Bayer Advanced Aspirin.

Intranasal Ketorolac Tromethamine (Sprix™ Nasal Spray) — Available
Regency Therapeutics and Daiichi Sankyo Co. Ltd. announced the commercial availability of their intranasal formulation of ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID) absorbed through nasal mucosa. The product received FDA approval in May 2010 but manufacturing was delayed due to the subsequent acquisition of the developing company by Daiichi Sankyo. The novel intranasal formulation — indicated for the short-term management of moderate to moderately-severe pain — has been shown to achieve peak blood levels as quickly as an intramuscular injection. Data from 4 controlled trials of surgical patients treated with Sprix reported statistically significant reductions in measures of pain and morphine use during a 48-hour period when compared with the placebo group. All ketorolac formulations should be prescribed for the shortest duration possible, not exceeding 5 days. The most frequently reported adverse effect was mild, transient nasal discomfort. Intranasal ketorolac is contraindicated in patients with a history of cerebrovascular bleeding, gastrointestinal bleeding, or advanced renal impairment. See the Sprix [prescribing information] for administration and safety recommendations.