New Antibiotic Hits the Market to Tackle Stubborn UTIs

No doubt about it, UTIs suck. They burn, they itch, they come back just when you think you’re in the clear. But for those dealing with these relentless infections, there’s finally a new line of defense.

A new type of antibiotic is now available for some of the most annoying infections around. This month, the Food and Drug Administration approved Iterum Therapeutics’ Orlynvah for certain kinds of urinary tract infections that aren’t likely to respond to other drugs.

UTIs are some of the most common infections that people encounter, particularly women. About 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 conditions) in their lifetime. While UTIs were once easily treatable with just about any simple course of antibiotics, many infections nowadays are resistant to at least one or more front-line drugs used against them. This added hardiness not only makes it harder to treat UTIs early before they cause more serious trouble, but also increases the risk of having recurrent UTIs. So scientists have been desperate to find newer antibiotics that can treat these resistant infections.

Orlynvah is the first drug of its kind. It contains a combination of sulopenem etzadroxil, which belongs to a subclass of antibacterials called penems, and probenecid, a renal tubular transport inhibitor that has been used in the past to boost the duration of antibiotics in our body. Penems are synthetic antibiotics that has shown great promise in treating a wide variety of commonly resistant germs, but Orlynvah is the first ever oral penem to be approved in the U.S.

The drug has been approved to treat certain uncomplicated UTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis bacteria. Importantly, Orlynvah is intended for people who have limited or no other alternative oral antibacterial options for their UTIs, such as infections that haven’t responded to past treatment or infections that show clear resistance to other drugs through testing. The FDA approved Orlynvah on the basis of two Phase III trials, which found that it outperformed or matched the effectiveness of other standard antibiotics for uncomplicated UTIs, including resistant infections.

“The FDA approval of sulopenem is tremendous 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.”

As valuable as Orlynvah will be for doctors and patients, the drug isn’t a cure-all for UTIs in general. 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 carefully managed to delay the emergence of bacterial strains that evolve resistance to it.

Still, Orlynvah should be able to prevent plenty 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. Left untreated, UTIs can also raise 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).