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New Faster Antibiotic Shown Effective for Skin Infections

Pills in a prescription bottle (Photos8.com)

(Photos8.com)

A clinical trial found an antibiotic tablet designed to work faster than existing oral drugs worked as well as the current drugs to treat bacterial skin infections, including those resistant to current antibiotics. The results of the trial testing the new tedizolid phosphate against the current linezolid appear in today’s issue of the Journal of the American Medical Association (paid subscription required).

The phase 3 clinical trial was funded and conducted by Trius Therapeutics Inc. in San Diego, the maker of tedizolid phosphate to treat acute bacterial skin and skin structure infections. These infections are treated today by linezolid, administered as a tablet or oral suspension twice a day for at least 10 days. Linezolid is marketed by by Pfizer under the brand name Zyvox. Treating acute bacterial skin and skin structure infections is complicated, however, by drug resistance including methicillin-resistant Staphylococcus aureus (MRSA), including some reported linezolid-resistant strains of MRSA.

Tedizolid phosphate is designed to be given once a day for six days. Trius says its tedizolid phosphate treatments were evaluated in a phase 2 clinical trial testing three dosage levels, as well as a series of phase 1 trials.

This latest trial enrolled 667 adults at 81 sites in the U.S., Europe, and Latin America. Participants in the trial were patients with acute bacterial skin and skin structure infections, about half of which were given tedizolid phosphate treatments — one 200 milligram dose for six days — while the remainder received 600 milligrams of linezolid twice a day for 10 days.

The trial was designed to test for the equivalence of the two treatments, not necessarily superiority of one treatment over the other. The investigators looked primarily for early indications (at 48 to 72 hours) of the drugs stopping the growth of skin lesions, and fever temperature of 99.7 degrees F or less.

The results showed almost identical early indications for the tedizolid phosphate (80%) and linezolid (79%) groups. Sustained treatment and post-therapy response rates for the two groups of patients were also with 1-2 percentage points. The post-therapy evaluations, given 7 to 14 days after treatments, showed among the 178 patients that contracted MRSA, equivalent high rates — 85 percent — of response to the respective drugs. Adverse responses by patients to the drugs were likewise about the same, 41 percent for tedizolid phosphate and 43 percent for linezolid.

In December, Trius completed enrollment of a second phase 3 clinical trial to test the efficacy and safety of tedizolid phosphate and linezolid when administered first as an intravenous infusion with the option to switch to oral therapy.

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