A recent urinary tract infection drug, Orlynvah, receives FDA approval, opening recent treatment options for patients with narrow or no alternative antimicrobial treatments.
Urinary tract infection (UTI) is a common infection of the urinary tract, and almost half of people assigned female at birth (AFAB) will experience such an infection during their lifetime. Although UTIs are less common in men, they can still occur. It may also affect approximately 1% to 2% of children.
Orlynvah, an oral tablet from drugmaker Iterum Therapeutics, containing sulopenem etzadroxil iprobenecid approved for operate specifically in the treatment of uncomplicated urinary tract infections (UTIs) in adult women. An uncomplicated urinary tract infection is a bacterial infection of the urinary tract without structural abnormalities.
The recent drug could be a game-changer for people with narrow treatment options, having shown effectiveness in two gigantic clinical trials involving more than 3,800 participants. The study results also showed that Orlynvah would work similarly to or even better than established antibiotics such as ciprofloxacin and amoxicillin.
“The FDA approval of ORLYNVAH™ is great news for those of us who have been hoping for a recent treatment option for appropriate at-risk patients suffering from UTIs. Based on the total clinical data generated, ORLYNVAH™ may be an essential treatment alternative for operate in the community,” said Dr. Marjorie Golden, director of the infectious diseases center at St. Raphael Campus Yale Novel Haven w press release.
However, Orlynvah has not been shown to be effective in treating patients with complicated urinary tract infections and complicated intra-abdominal infections.
The medicine can be prescribed to be used twice a day for 5 days.
“ORLYNVAH™ gives recent hope to patients suffering from difficult-to-treat UUTI. The introduction of creative products such as ORLYNVAH™ is an essential way to combat microbial resistance to other approved oral agents and represents a potential solution for patients and physicians,” said Corey Fishman, CEO of Iterum.
Safety information:
Although Orlynvah is generally considered secure, some common side effects may occur, such as diarrhea, nausea, vaginal yeast infection, headache, and vomiting.
Orlynvah is not recommended for people suffering from gout as it may worsen gout symptoms. The drug should not be taken by patients who experience hypersensitivity reactions to sulopenem, etzadroxil, probenecid or other beta-lactam antibacterial drugs. It is also not secure for patients with blood disorders, uric acid-induced kidney stones, and people taking ketorolac tromethamine.