The FDA approval is based on results from one of the largest studies conducted to date of hospitalized patients with complicated skin and skin structure infections (cSSSI). The study showed the drug to be well-tolerated and effective in the treatment of cSSSI when administered at 500mg every eight hours.
This international, multicenter clinical trial of 1,037 patients with cSSSI demonstrated an excellent success rate in patients infected with different aerobes and pathogens. The most common adverse effects observed were headache, nausea, constipation, diarrhea, anemia, pain, and pruritus.
“The FDA approval of Merrem represents a welcome therapeutic option for physicians who treat complicated skin and skin structure infections, which are more severe, can progress more rapidly, and pose a greater risk of spreading throughout the body than uncomplicated skin and soft tissue infections,” said David Melnick, senior medical director for infection and oncology at AstraZeneca.
Merrem is currently indicated and approved for use in the US as a single agent therapy for intra-abdominal infections and bacterial meningitis.