Fresh Antibacterial Agent Debuts to Overcome Persistent Urinary Tract Infections
Undeniably, UTIs are a hassle. They sting, they irritate, and they have a habit of coming back just when you think you've won the battle. But for those battling these persistent infections, there's now a fresh weapon in the arsenal.
This month, the Food and Drug Administration gave the green light to Iterum Therapeutics' Orlynvah for certain types of urinary tract infections that aren't likely to yield to other medications.
UTIs are some of the most common ailments people encounter, especially women. Approximately 60% of women in the U.S. are estimated to experience at least one uncomplicated UTI (a UTI with no signs of structural damage or other health issues) in their lifetime. While UTIs were once easily vanquished with a simple round of antibiotics, many infections today are immune to at least one or more first-line drugs used against them. This newfound toughness not only makes it harder to treat UTIs before they cause more trouble, but also increases the risk of recurring UTIs. As a result, researchers have been on the hunt for new antibiotics that can tackle these resistant infections.
Orlynvah is the first drug of its kind. It incorporates sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor. Penems are synthetic antibiotics that have shown remarkable promise in treating a variety of commonly resistant germs. Orlynvah is the first oral penem to be approved in the U.S., making it a significant breakthrough.
The drug has been approved to tackle certain uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis bacteria. Crucially, Orlynvah is intended for individuals with limited or no other oral antibacterial options for their UTIs, such as infections that haven't responded to previous treatment or infections that show clear resistance to other drugs through testing. The FDA approved Orlynvah based on two Phase III trials, which found that it outperformed or matched the effectiveness of standard antibiotics for uncomplicated UTIs, including resistant infections.
“The FDA approval of sulopenem is fantastic news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs,” said Marjorie Golden, an infectious disease specialist at the St. Raphael Campus of Yale New Haven Hospital who was involved in the drug’s clinical research, in a statement from Iterum. “Based on the totality of clinical data generated, sulopenem has the potential to be an important treatment alternative for use in the community.”
Despite Orlynvah's value, it's not a miracle cure for UTIs. The drug failed to pass clinical trials testing its effectiveness against complicated UTIs or complicated intra-abdominal infections. And like many newer antibacterial drugs, its use will be closely monitored to delay the emergence of bacterial strains resistant to it.
However, Orlynvah should be able to alleviate a significant amount of UTI-related misery. While these infections aren't always apparent, they can cause pelvic pain, frequent and/or burning urination, and even blood in urine. Untreated UTIs can also increase the risk of a more serious kidney infection, a narrowed urethra in men, and even sepsis (a life-threatening inflammation that can cause widespread organ damage).
The development of Orlynvah is a testament to the advances in technology and science, as it incorporates sulopenem etzadroxil, a penem antibacterial, and probenecid, utilizing the potential of synthetic antibiotics to combat resistant bacteria. In the future, innovative medications like Orlynvah may significantly improve healthcare outcomes for individuals battling antibiotic-resistant infections.
