The increasing prevalence of resistant bacteria often necessitates the use of combinations of antibiotics to fight infections.
Antibiotic resistance costs U.S. society between $4 billion and $5 billion annually.

According to the CDC ( U.S. Centers for Disease Control and Prevention ), antibiotic resistance has become so widespread that many significant bacterial infections in the world are becoming resistant to commonly used antibiotics.

Additionally, few broad-spectrum antibiotic agents are currently in development.
In fact, development and approvals of new antibacterial agents have decreased by 56 percent over the past 20 years ( 1998-2002 vs. 1983-1987 ).

Tygacil ( Tigecycline ), the first antibiotic approved in a new class called glycylcyclines, was developed by Wyeth to overcome key mechanisms of resistance that have affected antibiotic use.

Tygacil is approved for adults with complicated skin and skin structure infections ( cSSSI ) caused by Escherichia coli, Enterococcus faecalis ( Vancomycin-susceptible isolates only ), Staphylococcus aureus ( Methicillin-susceptible and -resistant isolates ), Streptococcus agalactiae, Streptococcus anginosus grp. ( includes S. anginosus, S. intermedius, and S. constellatus ), Streptococcus pyogenes, and Bacteroides fragilis.

Tygacil is also approved for adults with complicated intra-abdominal infections ( cIAI ) caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis ( Vancomycin-susceptible isolates only ), Staphylococcus aureus ( Methicillin-susceptible isolates only ), Streptococcus anginosus grp. ( includes S. anginosus, S. intermedius, and S. constellatus ), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

The FDA approval is based on data from four pivotal phase III studies examining the safety and efficacy of Tygacil for the treatment of cIAI and cSSSI.

In clinical trials, empiric monotherapy with Tygacil provided comparable clinical cures rates in cSSSI to Vancomycin and Aztreonam, a combination treatment.

Empiric monotherapy with Tygacil also provided clinical cure rates comparable to Imipenem/Cilastatin, an empiric treatment for cIAI. The overall discontinuation rate for Tygacil ( 5.0 percent ) was comparable to Vancomycin and Aztreonam ( 5.3 percent ) and Imipenem/Cilastatin ( 4.4 percent ).

Tygacil is contraindicated in patients with known hypersensitivity to Tigecycline.
Tygacil should be administered with caution in patients with known hypersensitivity to, and may have adverse effects similar to, tetracycline class antibiotics. In clinical trials, the most common treatment-emergent adverse events in patients treated with Tygacil were nausea ( 29.5 percent ) and vomiting ( 19.7 percent ).

Tygacil may cause fetal harm when administered to a pregnant woman.
The safety and effectiveness of Tygacil in patients below age 18 and lactating women have not been established.
Use of Tygacil during tooth development may cause permanent discoloration of the teeth.
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range from mild to life threatening.
Monotherapy should be used with caution in patients with clinically apparent intestinal perforation.

Source: Wyeth Pharmaceuticals, 2005


XagenaMedicine2005