Omadacycline (Nuzyra) maintained its potency over time and did not show a decrease in effectiveness.
Randy Brenner, chief development, and regulatory officer at Paratek Pharmaceuticals, Inc, company focusing on innovative therapies, with NUZYRA (omadacycline) approved for community-acquired bacterial pneumonia and acute bacterial skin infections.
Image credits: Paratek Pharmaceuticals
Omadacycline, the once-daily oral and intravenous antibiotic showed consistent effectiveness against a range of bacterial isolates with no emergence of resistance. The study, which analyzed 35,000 bacterial isolates collected between 2019 and 2023, demonstrated that omadacycline maintained consistent effectiveness across a range of bacterial isolates without any emergence of resistance. This large sample size underscores the reliability of the drug in managing bacterial infections.1
Omadacycline demonstrated consistent potency over five years, showing no decrease in effectiveness and confirming its reliability for treating community-acquired bacterial pneumonia (CABP) and acute bacterial skin infections (ABSSSI). Additionally, the absence of resistance development highlights that omadacycline remains effective against targeted pathogens, meeting the FDA’s standard requirements for new antibiotics.1
On July 18, 2024, Paratek unveiled its results from a phase 3 clinical trial evaluating the effectiveness of omadacycline (Nuzyra) in the treatment of moderate to severe CABP. In this study involving 670 patients at high risk for complications, omadacycline was compared to moxifloxacin, a standard treatment, highlighting its potential as a significant therapeutic option in addressing this serious respiratory condition.2
Randy Brenner, chief development, and regulatory officer at Paratek states, “Nuzyra is a tetracycline antibiotic, a class of antibiotics with more than 80 years of established safety heritage. In addition, Nuzyra has been extensively studied in clinical trials with more than 2600 patients now treated in completed trials. The product has been available commercially in the US for more than 5 years with more than 1.5 million days of therapy and a post marketing safety profile consistent with the tetracycline class, what we have seen in clinical trials, and the FDA prescribing information. In CABP trials conducted by Paratek, omadacycline and moxifloxacin demonstrated safety profiles consistent with their approved United States Prescribing Information (USPIs) and their classes of antibiotics.”2
The FDA approved an oral-only dosing regimen for omadacycline to treat adult CABP. This regimen started with 300 mg taken twice on day one, followed by 300 mg daily for 7 to 14 days. Omadacycline, designed to overcome tetracycline resistance, was effective against Gram-positive, Gram-negative, and drug-resistant bacteria. This approval enabled clinicians to treat patients in outpatient settings, potentially reducing hospitalizations and associated costs. Originally, omadacycline was approved by the FDA in October 2018 for CABP and ABSSSI.3
The results will be presented and published later this year, ensuring transparency and allowing the broader medical and scientific community to review the findings. Despite completing the initial five-year post-approval microbiologic surveillance study required by the FDA, Paratek Pharmaceuticals has decided to extend this surveillance program for additional years. This decision underscores the company’s commitment to ongoing monitoring of antimicrobial resistance and maintaining the effectiveness of omadacycline.
Paratek is conducting a Phase 2b clinical trial of omadacycline for the treatment of non-tuberculous mycobacterial (NTM) pulmonary disease caused by Mycobacterium abscessus complex, demonstrating the company's commitment to exploring omadacycline’s potential in treating serious infections beyond its initial indications.
