Paratek’s antibiotic Nuzyra™ (omadacycline) gains FDA approval

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The US FDA has approved Paratek Pharmaceuticals’ (MA, USA) antibiotic Nuzyra™ (omadacycline) for the treatments of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Nuzyra, a modernized tetracycline, has been shown to have activity across a range of bacteria including Gram-negative, Gram-positive, atypical and drug-resistant strains. Paratek hope to make the drug available in the first quarter of 2019.

The approval follows a positive advisory committee vote in August and was based on efficacy and safety data from three late-stage studies of the oral and IV formulations. Data reported in May demonstrated Nuzyra’s efficacy against CABP, while in June data was announced demonstrating the efficacy of Nuzyra compared with a placebo in treating ABSSSI patients.

Nicolette Theriault gave the patient perspective: “The approval of a new antibiotic might not mean a lot to some people, but to someone who has had more than one resistance skin infection, an effective antibiotic treatment could have made a big difference in my life and health.”

Antibiotic resistance has a real impact on patient’s lives, it’s one thing to analyze data and know statistics, but from my personal experience, having a painful and recurring skin infection is not a minimal thing – it affected my life in a big way. As a senior in college during my last semester I had a skin infection and cellulitis and ended up needing three surgical procedures within a 10 week period, which were not only painful, but took a long time to heal and prevented me from doing many daily activities.

I had an MRSA infection, the initial antibiotics I was prescribed in the emergency room didn’t work, the second antibiotics prescribed by the surgeon were changed a few days later, and changed again once my lab results came back positive for MRSA. The last round seemed to be working, but within a few weeks the infection had returned and I required surgery, IV antibiotics, and another round of oral antibiotics.

If I had been treated with an effective antibiotic earlier (at any point) I could have felt better sooner, potentially avoided having surgery (and had a more successful final semester).

Several years later, after having shoulder surgery, I developed a skin infection that was repeatedly treated over an 18 month period with antibiotics as well as infection site lancing and draining procedures.

The approval of a new antibiotic might not mean a lot to some people, but to someone who has had more than one resistance skin infection, an effective antibiotic treatment could have made a big difference in my life and health.

As part of the approval Paratek have agreed to post-marketing studies in CABP and pediatric patients. The company also recently received FDA approval of Seysara (sarecycline), a once-daily, oral, narrow spectrum tetracycline-derived antibiotic.

Evan Loh, President, Chief Operating Officer, and Chief Medical Officer of Paratek, concluded: “In the face of ever-increasing antibiotic resistance, the FDA approved NUZYRA with a label having full approval for both CABP and ABSSSI.  We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients.

“NUZYRA offers clinicians the ability to treat patients with the IV and transition them home to complete treatment with the oral formulation. This potentially helps reduce hospitalizations and the costs associated with hospital stays.”

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Source: https://www.nasdaq.com/press-release/paratek-announces-fda-approval-of-nuzyra-omadacycline-20181002-01269

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