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"The FDA approval of DIFICID is the culmination of Optimer's efforts to develop an innovative therapy for the treatment of CDAD," said
"The incidence and severity of CDAD has increased dramatically in the U.S. in the past decade and is continuing to rise each year," said
Important Safety Information
DIFICID should not be used for systemic infections. Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile.
The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
For full prescribing information for DIFICID, please call 1-855-DIFICID (1-855-343-4243) or visit www.DIFICID.com.
Addressing an Important Medical Need
CDAD is associated with a bacterial infection in the lining of the gut that can cause severe diarrhea, inflammation of the colon and in some cases death. Current estimates suggest CDAD may affect more than 700,000 people in the U.S. each year, though the incidence may be higher as many cases are believed to be undiagnosed, untreated, and underreported. A recent editorial in the
CDAD is noted for the significant number of patients who experience disease recurrence, or the reappearance of CDAD symptoms following initial antibiotic treatment. Approximately 20% to 30% of patients who initially respond to current treatments for CDAD experience a clinical recurrence following completion of antibiotic treatment. In patients who have experienced two or more prior episodes of CDAD, the risk of further recurrence increases to as much as 50-65%.
The disease adds significant costs and burden to the U.S. healthcare system. It is estimated that medical treatment and hospital stays associated with CDAD cost the U.S. healthcare system as much as
"DIFICID is an important addition for the treatment of patients with CDAD," said Dr.
About the Phase 3 Clinical Studies
The approval of DIFICID was based on results from two randomized, multi-center, double-blinded trials. A non-inferiority design was utilized to demonstrate the efficacy of DIFICID (200 mg orally twice daily for 10 days) compared to vancomycin (125 mg orally four times daily for 10 days) in adults with CDAD. The studies enrolled a total of 1,164 adults with confirmed CDAD.
The primary objective of both studies was to show that a 10-day course of DIFICID was as effective as oral vancomycin in achieving a clinical response at the end of therapy. An additional efficacy endpoint was sustained clinical response, defined as clinical response at the end of treatment and survival without proven or suspected CDAD recurrence through 25 days beyond the end of treatment.
In the first trial, conducted in
Scheduled Conference Call
Optimer will host a conference call on
Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities, and in the community. CDAD is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older.
Common therapeutic options for CDAD include oral vancomycin and the off-label use of metronidazole. However, approximately 20% to 30% of CDAD patients who initially respond to these treatments experience a clinical recurrence.
About DIFICID™ (fidaxomicin)
DIFICID is the first antibacterial drug indicated for CDAD to be approved in nearly 30 years. It is indicated for the treatment of CDAD in adults 18 years of age or older. DIFICID is administered in 200 mg tablets given orally twice daily. In two large Phase 3 clinical studies DIFICID had a clinical response rate at the end of the 10-day treatment period that was non-inferior to oral vancomycin. DIFICID demonstrated superior sustained clinical response, defined as clinical response that was maintained without proven or suspected CDAD recurrence through 25 days beyond the end of treatment, compared to oral vancomycin. This difference was due to lower rates of proven or suspected CDAD during the follow-up period in DIFICID-treated patients. Similar rates of clinical response at the end of treatment and proven or suspected CDAD during the follow-up period were seen in DIFICID-treated and vancomycin-treated patients infected with a BI isolate. The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%) and neutropenia (2%).
Optimer will conduct a microbiological surveillance program to identify the potential for decreased susceptibility of C. difficile to fidaxomicin, as well as two post-marketing studies in pediatric patients. The Company also plans to conduct a randomized clinical trial to evaluate the efficacy of DIFICID in the treatment of patients with multiple CDAD recurrences.
Forward Looking Statements
Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to Optimer's plans to commercialize DIFICID and partner with physicians and health systems, Optimer's and Cubist's ability to educate the medical community about DIFICID's advantages, the incidence of CDAD, potential benefits expected from Optimer's collaboration agreements with Cubist and Astellas, and Optimer's plans to conduct post-approval clinical trials of DIFICID. Words such as "believes", "would", "anticipates", "plans", "expects", "may", "intend", "will", and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. These forward-looking statements are based
on management's expectations on the date of this release. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the implementation and continuation of Optimer's agreements with Cubist and Astellas, Optimer's and its partners' ability to commercialize DIFICID according to Optimer's expected timelines, the ability of Optimer and its third party contractors to manufacture and supply sufficient quantities of DIFICID in accordance with Good Manufacturing Practices to meet demand, whether healthcare professionals will prescribe DIFICID, whether DIFICID will receive reimbursement coverage from healthcare payors and government agencies, the extent to which DIFICID will be accepted on hospital formularies, Optimer's ability to successfully recruit and retain
sales and marketing personnel, Optimer's ability to successfully manage a sales and marketing organization, Optimer's ability to initiate and complete planned post-approval clinical trials of DIFICID in a timely manner and the results of those clinical trials and other risks detailed in Optimer's filings with the
Optimer Pharmaceuticals, Inc.
John D. Prunty, Chief Financial Officer & Senior Vice President, Finance
Canale Communications, Inc.
Jason I. Spark, Senior Vice President
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