• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said top-line Phase III data of ceftobiprole in community-acquired pneumonia patients requiring hospitalization met the primary endpoint of noninferiority vs. the study comparators. Ceftobiprole, an anti-MRSA broad-spectrum cephalosporin, showed a clinical cure rate at the test-of-cure visit of clinically evaluable patients of 86 percent, compared to 87 percent for the comparators. The microbiological eradication rates were 88 percent and 92 percent, respectively. The drug generally was well tolerated. Ceftobiprole also is in development for complicated skin and skin structure infections, and Basilea reported separately that the Therapeutic Products Directorate of Health Canada accepted for review the new drug submission of ceftobiprole in that indication, which includes diabetic foot infections. The application was filed by partner Toronto-based Janssen-Ortho Inc., a Johnson & Johnson company. Ceftobiprole also is under review by regulatory authorities in the U.S. and Europe.

• Labopharm Inc., of Laval, Quebec, said results from its open-label, single-dose study of once-daily tramadol in patients with moderate to severe acute low-back pain suggested that the formulation provided therapeutic plasma concentrations and onset of analgesic effect within one hour, similar to results cited for the immediate-release tramadol product. The median duration to onset of relief was 45 minutes, at which time 78 percent of patients had moderate to complete pain relief. Those results were presented at a European anesthesia and pain conference in Valencia, Spain.

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