Tetraphase Pharmaceuticals,a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of "Eravacycline" for the treatment of complicated intra-abdominal infections (cIAI). In clinical trials, Eravacycline was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.

        Eravacycline is indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, Eravacycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

           Intra-abdominal infection (IAI) is a common problem in clinical practice and comprises a wide variety of disease processes. IAI is classified as uncomplicated or complicated based on the extent of the infection. Complicated intra-abdominal infections (cIAI) extend beyond the source organ into the peritoneal space (the space between the two membranes that separate the organs in the abdominal cavity from the abdominal wall) as a result of perforation or other damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. Different bacterial pathogens are responsible for cIAI, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. Early detection, containment and appropriate antimicrobial treatment are essential to the successful treatment of IAI. This is even more critical with increasing rates of infections caused by drug-resistant bacteria, which limit the effectiveness of currently available antibiotics.

               ERAVACYCLINE is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.ERAVACYCLINE is not indicated for the treatment of complicated urinary tract infections.To reduce the development of drug-resistant bacteria and maintain the effectiveness of ERAVACYCLINEand other antibacterial drugs, ERAVACYCLINE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ERAVACYCLINE is contraindicated for use in patients with known hypersensitivity to eravacycline or to tetracycline-class antibacterial drugs. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with ERAVACYCLINE.

        The use of ERAVACYCLINE during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.The use of ERAVACYCLINEduring the second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.