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Cerexa MRSA Treatment Fast Tracked By FDA

Posted on: Thursday, 16 March 2006, 21:00 CST

The FDA has granted fast track designation to Cerexa's PPI-0903, an antibiotic for the treatment of complicated skin and skin structure infections caused by methicillin-resistant staphylococcus aureus, or MRSA.

Cerexa initiated a phase II trial of PPI-0903 for the treatment of complicated skin and skin structure infections (cSSSI) in October 2005.

The fast track designation should help to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential to address unmet medical needs for such a condition.

In granting this designation, the FDA noted that PPI-0903 has the potential to address unmet medical need due to its ability to benefit patients who are unresponsive to existing therapies or who are unable to tolerate existing therapies due to serious toxicities that are present in such therapies.

"Given the increasing frequency and severity of resistance to existing therapies, our goal is to advance the development of PPI-0903 as rapidly as possible to benefit patients who are in need of new treatment options," stated Dennis Podlesak, CEO of Cerexa.

Patients with serious MRSA infections often require extensive medical procedures, resulting in prolonged hospitalization. Although several new antibiotics with activity against MRSA have been approved over the last six years, development of resistance to these newer agents has already been reported.

The reported resistance coupled with unwanted side effects limits the use of these antibiotics in some clinical situations; magnifying the importance of developing more effective antimicrobial agents.

Source: Datamonitor

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