Optimer rolls with its fidaxomicin NDA.(Wednesday, Sept. 22)

With the first section of its rolling new drug application (NDA) for fidaxomicin submitted to the FDA, Optimer Pharmaceuticals Inc., of San Diego, is seeking to be the first company on the U.S. market in 25 years with a new effective oral antibiotic to treat and prevent recurrences of Clostridium difficile infection (CDI), a disease that can cause serious diarrhea and other intestinal conditions, such as colitis, which sometimes results in death. The incidence of CDI has increased in the U.S. in recent years, with the spread of the infection becoming a significant problem in hospitals and long-term care facilities. It also is becoming more prevalent in the community, although as a less severe infection. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal flora, allowing C. difficile bacteria to flourish. ViroPharma Inc.'s Vancocin (vancomycin) is the only antibiotic approved in the U.S. to treat infections caused by C. difficile, with other drugs, like metronidazole, being used off-label, explained John Prunty, Optimer's chief financial officer. But up to 30 percent of CDI patients treated with vancomycin or other drugs experience a recurrence of the disease, he said. Fidaxomicin not only met its Phase III primary endpoint of noninferiority compared with vancomycin in treating C. difficile, but Optimer's drug was superior to vancomycin in preventing recurrences, the company said. And because fidaxomicin is a twice-daily oral medication, it gives patients and prescribers a more convenient option than vancomycin, which must be taken four times per day, Prunty noted. He said the firm expects to complete its rolling NDA "long before" the end of the year, with expectations to have its drug approved by mid-2011, if the FDA grants a priority review.

Optimer rolls with its fidaxomicin NDA.(Wednesday, Sept. 22)

With the first section of its rolling new drug application (NDA) for fidaxomicin submitted to the FDA, Optimer Pharmaceuticals Inc., of San Diego, is seeking to be the first company on the U.S. market in 25 years with a new effective oral antibiotic to treat and prevent recurrences of Clostridium difficile infection (CDI), a disease that can cause serious diarrhea and other intestinal conditions, such as colitis, which sometimes results in death. The incidence of CDI has increased in the U.S. in recent years, with the spread of the infection becoming a significant problem in hospitals and long-term care facilities. It also is becoming more prevalent in the community, although as a less …