No doubt about it, UTIs suck. They burn, they itch, they come back just when you think you’re safe. But for those dealing with these brutal infections, there is finally a new line of defense.
A new type of antibiotic is now available for some of the most nasty infections out there. This month, the Food and Drug Administration did so approved Orlynvah from Iterum Therapeutics for certain types of urinary tract infections that are unlikely to respond to other medicines.
UTIs are some of the most common infections faced by people, especially women. It is estimated that approximately 60% of women in the US will experience at least one uncomplicated urinary tract infection (a urinary tract infection without signs of structural damage or other health problems) during their lifetime. While urinary tract infections were once easily treatable with almost any simple course of antibiotics, many infections today are resistant at least one or more first-line medications used against them. This extra hardiness not only makes it harder to treat UTIs early before they cause more serious problems, but also increases the risk of recurring UTIs. So scientists are desperately looking for 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 antibacterial agents called penems, and probenecid, a renal tubular transport inhibitor that has been used in the past to prolong the duration of antibiotics in our body. Penems are synthetic antibiotics which has shown promise in treating a wide variety of often drug-resistant pathogens, but Orlynvah is the first oral penem ever approved in the U.S.
The drug is approved for the treatment of certain uncomplicated urinary tract infections 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 urinary tract infections, such as infections that have not responded to previous treatments or infections that show clear resistance to other drugs through testing. The FDA approved Orlynvah based on two Phase III studies, which showed it outperformed or matched the effectiveness of other standard antibiotics for uncomplicated urinary tract infections, including drug-resistant infections.
“The FDA approval of sulopenem is great news for those of us who have been hoping for a new option to treat eligible high-risk patients with urinary tract infections,” said Marjorie Golden, an infectious disease specialist at Yale New’s St. Raphael Campus. Haven Hospital, which was involved in the clinical trial of the drug, 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 to doctors and patients, the drug is not a panacea for urinary tract infections in general. The drug failed to pass clinical trials testing its effectiveness against complicated urinary tract infections or complicated intra-abdominal infections. And as with many newer antibacterial drugs, their use will be carefully managed to slow the emergence of bacterial strains that develop resistance to them.
Still, Orlynvah should be able to prevent a lot of UTI-related misery. Although these infections are not always visible, they can cause pelvic pain, frequent and/or burning urination, and even blood in the urine. Left untreated, urinary tract infections 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).