Omadacycline Approved for Treating CABP, ABSSSI Infections

The US Food and Drug Administration (FDA) has approved omadacycline (NUZYRA), a modernized tetracycline, for the treatment of Community-Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Structure Infections (ABSSSI) in patients with tetracycline-resistant conditions.

As the first approved once-daily intravenous (IV) and oral antibiotic for both CABP and ABSSSI in about 2 decades, the Paratek Pharmaceuticals drug becomes another asset in the era of treatment-resistant infection strains.

Drug-resistant bacteria currently causes about 2 million illness and 23,000 deaths in the US annually, according to the CDC. Streptococcus pneumoniae, the bacteria primarily behind CABP, is responsible for 1.2 million infections and 7000 deaths itself. On its own, ABSSSSI is responsible for 750,000-plus hospitalizations annually.

Capable of exhibiting activity across Gram-positive, Gram-negative, atypical, and other drug-resistant strains, omadacycline was given near-unanimous backing from the FDA’s Antimicrobials Drug Advisory Committee in early August. The committee voted 17-1 in favor of the drug’s efficacy and safety for ABSSSSI and 14-4 for the same for CABP, after reviewing Paratek’s global development program for the indications.

The program, a portfolio featuring a trio of phase 3 trials evaluating both IV and oral formulations of omadacycline, tested the therapy in almost 2000 adult patients. In all 3 studies, omadacycline met the FDA-designated primary and secondary efficacy outcomes while reporting consistent safety measures and tolerability.

Omadacycline is also being considered for urinary tract infection indications, and with these approvals, it has been progressed to post-marketing studies in CABP and pediatrics.

The approval is the second to be announced for a Paratek drug this week—sarecycline (SEYSARA) was approved to treat the inflammatory lesions of non-nodular moderate to severe acne vulgaris patients aged 9 years or older on Monday.

Paratek expressed excitement to launch the drug early next year.

“We are excited to bring to physicians an effective, well-tolerated monotherapy option for patients,” Evan Loh, MD, president, chief operating officer, and chief medical officer of Paratek, said in a statement. “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.”