BURLINGTON, Mass., April 3, 2014 /PRNewswire/ -- Decision Resources Group finds that following its launch, Cubist's second generation oxazolidinone Sivextro will be highly differentiated from other anti-MRSA (methicillin-resistant Staphylococcus aureus) agents for the treatment of complicated skin and skin structure infections (cSSSIs) due to MRSA. In particular, Sivextro's once-daily dosing, shorter course of therapy, and its potential for lower treatment-related adverse events are notable improvements over Pfizer's Zyvox/Zyvoxid, the current market share leader for MRSA cSSSIs. Accordingly, in March 2014, the FDA's Anti-Infective Drugs Advisory Committee unanimously recommended Sivextro's approval for the treatment of cSSSIs.
Other key findings from the DecisionBase report entitled Methicillin-Resistant Staphylococcus Aureus Complicated Skin and Skin Structure Infections: In The Crowded MRSA cSSSI Market, How Will Emerging Therapies Differentiate Themselves from Current Standard of Care?:
- Importance of early clinical response rates for MRSA cSSSIs: Less than 40 percent of surveyed European infectious disease (ID) specialists chose early clinical response rate among their top three most persuasive end points when evaluating new antibiotics for MRSA cSSSIs, compared with nearly 60 percent of surveyed U.S. ID specialists who ranked this end point accordingly. This finding highlights the impact of the FDA's recommendation for use of early response as the primary end point in clinical trials.
- Payer receptivity to new anti-MRSA agents with a shorter length of therapy: As U.S. hospitals aim to contain healthcare costs, hospital pharmacy directors will seek therapies that help reduce the cost of managing MRSA cSSSIs, including agents that promote earlier discharge. Nearly two-thirds of surveyed pharmacy directors support formulary inclusion of agents with a shorter course of therapy than Zyvox/Zyvoxid, and are priced similarly or at a premium to a seven-day course of Zyvox/Zyvoxid.
- Future impact of Dalvance and oritavancin on current therapies: Surveyed ID specialists indicate that Durata's Dalvance and The Medicines Company's oritavancin will gain uptake at the expense of vancomycin and Cubist's Cubicin. With long systemic half-lives allowing for convenient once-weekly or single dosing, respectively, we expect both agents will compete for MRSA cSSSI patients who require further antibiotic therapy at discharge or are candidates for outpatient parenteral antibiotic therapy.
Comments from Decision Resources Group Analyst Maria Ascano Ph.D.:
- "Although ID specialists consider efficacy to be the most important drug attribute for treating MRSA cSSSIs, the availability of many highly effective therapies will make it difficult for new entrants to differentiate themselves on efficacy improvements alone. However, because this segment of the market is dominated by older less well-tolerated parenteral antibiotics, developers can highlight safety and delivery improvements to capitalize on market opportunities."
- "Therapies that can help promote early discharge or reduce hospital admissions will gain favorable uptake as healthcare providers aim to reduce hospital-associated costs. Therefore, agents providing convenient use in the outpatient setting, including availability in IV and oral formulations, shorter courses of therapy, or infrequent dosing, will be highly differentiated in this crowded market segment."
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