Iterum Therapeutics Launches ORLYNVAH, Oral Penem Antibiotic for UTIs.

Iterum Therapeutics has launched ORLYNVAH, the first oral penem antibiotic in the US. The FDA-approved antibiotic offers a vital alternative for treating uncomplicated urinary tract infections. The drug is a novel oral formulation of sulopenem etzadroxil and probenecid, offering a solution for adult women with uUTIs caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis.

Dublin-based Iterum Therapeutics has made a significant stride in the pharmaceutical landscape with the commercial launch of ORLYNVAH, the first oral penem antibiotic in the United States. The FDA-approved drug offers a vital alternative for treating uncomplicated urinary tract infections (uUTIs) in adult women [1].

ORLYNVAH is a novel oral formulation of sulopenem etzadroxil and probenecid, designed to address uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis. The drug is particularly notable for being the first oral penem antibiotic to receive FDA approval, providing a long-overdue treatment option for a condition that affects 60% of women at some point in their lives [2].

The launch of ORLYNVAH comes at a critical juncture as antimicrobial resistance continues to erode the effectiveness of traditional antibiotics. According to a 2024 U.S. study, 57% of initial uUTI infections were resistant to at least one antibiotic class, and 13% were resistant to three or more [2]. The introduction of ORLYNVAH aims to address this growing challenge by offering a new, effective oral therapy.

Iterum Therapeutics has implemented a dual-track approach to bring ORLYNVAH to market, combining potential partnerships with internal launch preparations. The company has partnered with Eversana Life Sciences Services and a specialty pharmacy to support the drug's distribution and commercialization [1].

The company plans to initially target 20 geographies in phase one of its launch, focusing on regions with high antibiotic resistance rates, high-prescribing doctors for uUTIs, and favorable market access rates. The primary goal of this phase is to generate market demand and demonstrate the drug's value [1].

ORLYNVAH is priced between $1,400 and $4,700 per prescription, with eligible patients able to pay as little as $25 through a copay savings program. The pricing aligns with other branded oral antibiotics that have debuted in recent years, reflecting the drug's role as an acute infection treatment rather than a regularly prescribed medication [1].

While competition is expected with the upcoming launches of uUTI treatments from GSK and Alembic Pharmaceuticals, Iterum Therapeutics remains optimistic about ORLYNVAH's market potential. The company aims to capture 5% of the market, translating to more than a million prescriptions at peak, and expects the entrance of new players to highlight the broader issue of antibiotic resistance [1].

References:

[1] https://www.fiercepharma.com/pharma/breaking-down-dual-track-strategy-behind-iterums-launch-first-new-uncomplicated-uti-drug

[2] https://www.globenewswire.com/news-release/2025/08/20/3136342/0/en/Iterum-Therapeutics-launches-ORLYNVAH-the-first-and-only-oral-penem-antibiotic-in-the-U-S.html