Optimer Pharmaceuticals, a finder, developer and commercializer of hospital specialty products, has received the US Food and Drug Administration's (FDA) approval for its antibacterial drug Dificid (fidaxomicin) pills.
Dificid tablets are pointed for the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults 18 years of age or older.
The FDA approval was given on the basis of the positive results from II Phase 3 randomized, multi-center, double-blinded trials involved 1,164 patients suffering from CDAD that compared Dificid with vancomycin, a usual antibiotic drug used to treat CDAD.
The results of the trial suggested that Dificid was higher-up to vancomycin in sustaining clinical response through 25 days on the far side the end of treatment.
Optimer president and chief executive officer(CEO) Pedro Lichtinger said the clinical development program for DIFICID was designed to address one of the greatest challenges in managing CDAD, disease recurrence.
"We are proud to provide the medical community and patients with an effective treatment proven to produce confirmed clinical response in CDAD, and are now moving into the commercialization stage where we'll partner with physicians and health systems to ensure that DIFICID reaches patients in urgent demand of an important new treatment option," Lichtinger said.http://www.pharmaexhibtion.blogspot.com
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