More alternatives to Vioxx and Celebrex offered

Since the recall of Vioxx and widespread speculation that both Celebrex and Bextra may be recalled as well in coming months, companies are trying to come up with alternatives to Cox-2 drugs. Supporters of Cox-2 inhibitors have been somewhat disappointed with recent studies that have shown an increased risk of heart attacks since the drugs were initially thought to be a revolution in pain relief for arthritis patients. (Related article: Pain relief drugs guide)

One company that we had highlighted recently is Dimethaid, based in Canada and maker of Pennsaid (Related article: Topical cream Pennsaid for pain relief for users of Vioxx, Bextra, and Celebrex). The growth of the drug has been remarkable in the last quarter of 2004 and reflects the establishment of Pennsaid in the Canadian market as well as the first shipment of product to its Portuguese partner Jaba Farmacêutica in advance of an official launch in early calendar 2005.

The company expects that Canadian Pennsaid sales will continue to grow based on:

• The recent publication of three Pennsaid clinical studies demonstrating safety and efficacy in prestigious Canadian and U.S. medical journals;
• A fully funded sales and marketing campaign led by our co-promotion partner Solvay Pharma;
• Arthritis patients' increasing need for treatment alternatives given the recent safety issues with COX-2s and traditional oral NSAIDS; (Related article: Aleve recall demanded after safety concerns)
• Establishing and enhancing relationships with key opinion leaders in the field of arthritis in Canada.

Another company that is working on an alternative to Vioxx and Bextra is BioDelivery Sciences International. The company recently applied its licensed and patented Bioral “nanocochleate” drug delivery technology to aspirin and traditional non-steroidal anti-inflammatories (NSAIDS) that are not selective COX-2 inhibitors. BDSI contracted with an independent testing laboratory to test its Bioral formulations of aspirin and other NSAIDs in a well-established animal model of inflammation. These proof-of-principle animal studies have demonstrated that encochleated NSAIDS enabled a statistically significant reduction in gastro-intestinal toxicity compared to standard formulations at clinically-relevant high doses of these NSAIDs and aspirin while providing comparable anti-inflammatory effects. (Related article: Vioxx alternative Celebrex increases risk of heart attack)

The Bioral technology uses soy-derived phospholipid and calcium to envelope (or “cochleate”, derived from the Greek word for “shell”) the drug in such a way that it appears to allow absorption to occur without the NSAID coming into contact with the gastric mucosa, thus reducing the incidence of mucosal ulceration that is often associated with NSAID and aspirin use. The major alleged benefit of the selective COX-2 inhibitors over the NSAIDs has been reduced gastrointestinal damage. However, the new laboratory findings show that it may be possible for this benefit to now be matched by applying the Bioral technology to NSAIDs and aspirin. In addition, these proof-of-principle findings show that nanoencochleated NSAIDs may reduce the common and expensive use of NSAIDs with H2 antagonists and proton pump inhibitors to protect the gastrointestinal lining of patients taking NSAIDs.

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