Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Optimer Pharmaceuticals, a discoverer, developer and commercializer of hospital specialty products, has received the US Food and Drug Administration's (FDA) approval for its antibacterial drug Dificid (fidaxomicin) tablets.
Subscribe to our email newsletter
Dificid tablets are indicated 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 two Phase 3 randomized, multi-center, double-blinded trials involved 1,164 patients suffering from CDAD that compared Dificid with vancomycin, a common antibiotic used to treat CDAD.
The results of the trial suggested that Dificid was superior to vancomycin in sustaining clinical response through 25 days beyond the end of treatment.
Optimer president and 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 sustained clinical response in CDAD, and are now moving into the commercialization stage where we will partner with physicians and health systems to ensure that DIFICID reaches patients in urgent need of an important new treatment option," Lichtinger said.