FDA ( Food and Drug Administration ) approved antibiotic Merrem iv ( Meropenem for injection ) to treat adults and children with complicated skin and skin structure infections ( cSSSI ).
Merrem, a broad-spectrum carbapenem injectable antibiotic, currently is indicated and approved for use in the United States as a single agent therapy for intra-abdominal infections and bacterial meningitis.
The approval is based on results from one of the largest studies conducted to date of hospitalized patients with cSSSI.
The study showed that Meropenem, administered 500 mg IV every 8 hours, is a well-tolerated and effective treatment for patients with cSSSI, including the elderly and patients with diabetes mellitus.
A Phase III, randomized, double-blind, multicenter clinical trial of 1,037 patients with complicated skin and skin structure infections compared the efficacy, safety and tolerability of Meropenem, given at 500 mg IV every 8 hours, and Imipenem-Cilastatin given at 500 mg IV every 8 hours.
The primary efficacy end point was clinical outcome at follow-up in the clinically evaluable and modified intent-to-treat ( MITT; patients who met eligibility criteria and received greater than or equal to 1 dose of study drug ) populations.
The success rates in the clinically evaluable patients at the follow-up visit were 86% in the Meropenem arm and 83 percent in Imipenem-Cilastatin arm and 73 percent ( Meropenem ) and 75 percent ( Imipenem-Cilastatin ) in the MITT population.
The frequency of adverse events and drug-related adverse events were similar between treatment groups.
The most common adverse events reported in both treatment groups were headache, nausea, constipation, diarrhea, anemia, pain, and pruritus.
Among clinically evaluable patients 65 years of age and over, 81 percent of patients treated with Meropenem had a satisfactory clinical response at follow-up, compared with 72 percent of patients treated with Imipenem-Cilastatin.
Similarly, in the clinically evaluable population, among those with diabetes mellitus, 86 percent of patients treated with Meropenem had a satisfactory clinical response at follow-up, compared with 72 percent of patients treated with Imipenem-Cilastatin.
Among patients with microbiologically-documented infection, Meropenem demonstrated an excellent success rate in patients infected with Gram-positive aerobes ( 88 percent versus 83 percent ), Gram-negative aerobes ( 80 percent versus 75 percent ), and anaerobic pathogens ( 84 percent versus 85 percent; Meropenem versus Imipenem-Cilastatin ).
The pivotal clinical trial was supported by a pharmacokinetic trial demonstrating that Meropenem administered at 500 mg IV every 8 hours achieves levels in interstitial skin fluid sufficient to treat the common pathogens associated with complicated skin infections.
There are approximately 1.5 million patients who annually receive broad- spectrum antibiotics in hospitals for cSSSI. Complicated skin and skin structure infections involve the skin and may involve deeper soft tissues, often requiring surgical intervention and antibiotic therapy. These infections include complicated cellulitis, complex abscesses, perirectal abscesses, and other skin infections requiring intravenous antimicrobials and hospitalization.
Meropenem is generally well tolerated and has a low incidence of adverse events.
Systemic adverse events reported with Meropenem are typical of those seen with other intravenous antibiotics and include diarrhea, nausea, vomiting, and headache. Serious and occasionally fatal hypersensitivity ( anaphylactic ) reactions have been reported in patients receiving therapy beta-lactams.
Source: AstraZeneca, 2005