A new drug for urinary tract infections, Orlynvah, gets FDA approval, opening new treatment options for those patients with limited or no alternative antibacterial treatments.

A urinary tract infection (UTI) is a common infection that affects the urinary system, and nearly half of all people assigned female at birth (AFAB) will experience one in their lifetime. Although UTIs are less common in men, they can still occur. Around 1% to 2% of children may also be affected.

Orlynvah, an oral tablet from drug manufacturer Iterum Therapeutics, combining sulopenem etzadroxil and probenecid has been approved for use specifically for treating uncomplicated urinary tract infections (UTIs) in adult women. An uncomplicated urinary tract infection is a bacterial infection of the tract without abnormalities in the structure.

The new medicine could be a game-changer for those with limited treatment choices, as it showed effectiveness in two large clinical trials with over 3,800 participants. The trial results also indicated that Orlynvah would work similar, or even better than, traditional antibiotics like ciprofloxacin and amoxicillin.

"The FDA approval of ORLYNVAH™ is tremendous news for those of us who have been hoping for a new option to treat appropriate at-risk patients suffering from UTIs. Based on the totality of clinical data generated, ORLYNVAH™ has the potential to be an important treatment alternative for use in the community," said Dr. Marjorie Golden, Site Chief, Infectious Disease, St. Raphael Campus Yale New Haven Hospital in a news release.

However, Orlynvah did not show effectiveness in treating patients with complicated urinary tract infections and complicated intra-abdominal infections.

The drug could be prescribed to be taken twice daily for 5 days.

"ORLYNVAH™ offers new hope for patients suffering from difficult-to-treat uUTIs. The introduction of novel products, like ORLYNVAH™, is an important way to combat antimicrobial resistance to other approved oral agents and offers a potential solution to patients and physicians," said Corey Fishman, Iterum's Chief Executive Officer.

Safety information:

Though Orlynvah is generally deemed safe, there can be certain common side effects such as diarrhea, nausea, vaginal yeast infection, headache, and vomiting.

Orlynvah is not recommended for those who have gout as it can aggravate symptoms of gout. The drug should not be taken by those patients who have hypersensitivity reactions to sulopenem etzadroxil and probenecid or other beta-lactam antibacterial drugs. It is also not safe for patients with blood dyscrasias, uric acid kidney stones, and those on ketorolac tromethamine.

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