Reports From The Field-New drug updates
FDA approves first new antibiotic in 35 years
The Food and Drug Administration recently approved the first new class of antibiotics in 35 years. Zyvox (linezoid injection, tablets, and oral suspension), from Pharmacia & Upjohn in Peapack, NJ, was approved for the treatment of gram-positive bacteria.
The new antibiotic is indicated for treatment of the following conditions in adults:
• hospital-acquired pneumonia;
• community-acquired pneumonia;
• complicated and uncomplicated skin and skin structure infections;
• vancomycin-resistant Enterococcus infections;
• complicated skin infections caused by methicillin-resistant Staphylococcus aureus;
• nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus;
• concurrent bacteremia associated with community-acquired pneumonia caused by penicillin-susceptible Streptococcus pneumoniae.
Clinical studies involving more than 4,000 patients treated primarily in the hospital have demonstrated that Zyvox is effective in treating infections caused by gram-positive bacteria, including some bacteria resistant to other antibiotics.
Zyvox belongs to a new class of antibiotics, the oxazolidinones. The drug attacks bacteria by stopping protein production at a very early point in the process that is different from any other currently approved antibiotic. Without protein production, bacteria cannot multiply, and they die quickly.
Drug treats severe neuropathic pain
Roxane Laboratories in Columbus, OH, has announced the availability of Duraclon (clonidine HCI injection, 500 mg/mL), for the epidural treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. The higher Duraclon concentration offers increased flexibility and convenience in treating cancer patients with severe neuropathic pain.
"While analgesia can be effectively managed with opioids in most cancer patients, those suffering from severe neuropathic pain often require more relief than opioids alone can provide," says Stuart DuPen, MD, associate director for pain research at Swedish Medical Center and clinical professor of anesthesiology and pain management at the University of Washington, both in Seattle.
"For these patients, Duraclon therapy offers an alternative to the invasive surgical procedures conventionally used to relieve hard-to-reach neuropathic pain," he says.
When used in combination with epidural opioids, Duraclon can be administered concomitantly with opioid analgesics for enhanced pain relief. In a clinical trial in cancer patients, Duraclon with epidural opioids provided significantly better analgesia than morphine alone: 45% compared with 21%. Duraclon with epidural morphine also provided relief to 56% of patients with neuropathic pain, compared with 5% of those receiving morphine alone. Duraclon is not recommended for pain management in obstetrical, postpartum, or perioperative patients.
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