Contezolid Gets QIDP, Fast Track Status for Acute Bacterial Skin/Skin Structure Infections

Contezolid and contezolid acefosamil are next-generation oxazolidinone agents
Contezolid and contezolid acefosamil are next-generation oxazolidinone agents

The Food and Drug Administration (FDA) has granted Qualified Infections Disease Product (QIDP) and Fast Track status to contezolid (MRX-I) and its prodrug contezolid acefosamil (MRX-4) for the treatment of acute bacterial skin and skin structure infections (ABSSSI)

Contezolid and contezolid acefosamil (MicuRx Pharmaceuticals) are next-generation oxazolidinone agents that are active against multidrug-resistant, Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). The structure of contezolid was designed to potentially reduce the risk of hematological toxicity associated with this class of antibiotics.

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“Despite recent antibiotic launches, unmet needs still exist for an oral anti-MRSA agent with a safety profile appropriate for extended treatment, especially in the outpatient setting,” stated Barry Hafkin, M.D., MicuRx's Chief Medical Officer. “We believe that our contezolid portfolio offers a unique profile with excellent clinical safety and efficacy results to date, with the flexibility of intravenous and oral formulations." A US Phase 2 study of oral and IV contezolid acefosamil in ABSSSI is scheduled to begin before the end of 2018.

Fore more information visit Micurx.com.