Daptomycin for injection (Cubicin®, Cubist Pharmaceuticals, Inc.) has been approved by the FDA to treat complicated infections of the skin and its structures.
Cubicin® was previously known as Cidecin®. Cubist acquired worldwide development and commercialization rights to the product from Eli Lilly & Co. in 1997.
Usually occurring in hospitalized patients, these cutaneous problems can include major abscesses, postsurgical skin wound infections, and infected ulcers. The infections are usually caused by susceptible strains of gram-positive microorganisms, such as Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dys-galactiae subspecies equisimilis, and Enterococcus faecalis (vancomycin-susceptible strains only). Cubicin is not indicated for the treatment of pneumonia.
Cubicin® is the first approved product in a new class of antibiotics called cyclic lipopeptide antibacterial agents and treats infections in a way that is distinct from any other antibiotic.
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The FDA based its approval on a review of clinical studies involving more than 1,400 adults. The studies demonstrated that Cubicin® was equivalent to other standard treatments.
Most reported adverse events were mild to moderate in intensity, such as gastrointestinal disorders, injection-site reactions, fever, headache, insomnia, dizziness, and rash.
Blood tests showing muscle injury were rarely found in patients in clinical trials. Most of these patients had no symptoms, and values returned to normal after therapy.
Patients receiving Cubicin® should be monitored for the development of muscle pain or weakness, and creatine phos-phokinase levels should be assessed weekly.
The manufacturer expects the medication to be available by early November 2003.