INVANZ® Approved for Treatment of Moderate to Severe Foot Infection in Patients with Diabetes

       Merck & Co. Inc. (Whitehouse Station, NJ) announces approval from the US Food and Drug Administration (FDA) for INVANZ^® (ertapenem), a once-daily injectable antibiotic treatment for moderate to severe complicated foot infection due to indicated pathogens in patients with diabetes without osteomyelitis. The approval was based on the results of the SIDESTEP study, the largest prospective, randomized, double-blind clinical trial ever conducted in patients with diabetes and moderate to severe complicated foot infection.
INVANZ is indicated for the treatment of moderate to severe complicated skin and skin structure infections including diabetic foot infections without osteomyelitis due to Staphylococcus aureus (methicillin susceptible isolates only), Streptococcus agalactiae, Streptococcus pyogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Bacteroides fragilis, Peptostreptococcus species, Porphyromonas asaccharolytica, or Prevotella bivia.
       INVANZ has not been studied in diabetic foot infections with concomitant osteomyelitis. Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to ertapenem. Therapy with INVANZ may be initiated empirically before results of these tests are known; once results become available, antimicrobial therapy should be adjusted accordingly.
       INVANZ is contraindicated in patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. Due to the use of lidocaine HCl as a diluent, INVANZ administered intramuscularly is contraindicated in patients with known hypersensitivity to local anesthetics of the amide type. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
       Visit http://www.merck.com for more information.

Study Indicates Microcyn™ Technology Reduces Microbial Load

       Oculus Innovative Sciences, Inc. (Petaluma, Calif) announces results of a 218-patient controlled clinical study. The study assessed the safety and efficacy of Microcyn™ Technology (a pH-neutral, super-oxidized water) in treating diabetic foot ulcers compared to povidone iodine (10%) antiseptic, which is often used in treatment of open wounds.
       In the study, the super-oxidized water technology proved superior to the iodine relative to the reduction of the number of bacterial strains, local adverse effects, surgical dehiscence (incidence of not healing after surgery due to infection or ischemia), and healing time.
       The key endpoint of the study was microbial load reduction at entry and surgery (or follow-up). The group treated with the super-oxidized water technology showed a significantly improved rate of reduction of microbial load and healing time in open wounds as compared to the povidone iodine group. Of the ulcers in the water technology group, 88.2% had a negative microbiological specimen versus 68.5% in the povidone iodine group. The group treated with the super-oxidized water technology had no local adverse effects, while the povidone iodine group experienced 18 incidences of such effects.
       E-mail dmcfadden@oculusis.com or call 425-836-3103 for more information.