FDA Gives MRX-I QIDP, Fast Track Status for Acute Bacterial Skin Infections

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.

“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.

This article originally appeared on MPR