The FDA has granted approval to Orlynvah (sulopenem etzadroxil and probenecid), a novel oral treatment for uncomplicated urinary tract infections (UTIs) in adult women who have exhausted other oral antibiotic therapies. This approval addresses a critical need for alternative treatments due to increasing antibiotic resistance.
Addressing Unmet Needs in UTI Treatment
UTIs are highly prevalent, affecting approximately half of all women at least once in their lives. While many cases are easily treated with standard antibiotics, some infections, particularly those caused by resistant bacteria like E. coli, Klebsiella pneumoniae, and Proteus mirabilis, pose significant challenges. Orlynvah offers a new approach by combining sulopenem etzadroxil, a broad-spectrum penem antibiotic, with probenecid, which prolongs sulopenem's presence in the body by reducing its renal clearance.
Clinical Trial Evidence
The FDA's decision was supported by data from two large clinical trials involving over 3,800 women. These studies compared Orlynvah's efficacy to that of commonly used antibiotics like ciprofloxacin and amoxicillin-clavulanate. The results indicated that Orlynvah was as effective as, or more effective than, these traditional treatments in eradicating the infection. Specifically, the trials demonstrated Orlynvah's effectiveness against pathogens susceptible to amoxicillin-clavulanate, as well as pathogens resistant to ciprofloxacin.
Expert Commentary
Dr. Marjorie Golden, an infectious disease specialist at Yale New Haven Hospital, highlighted the importance of Orlynvah as a much-needed alternative. "Orlynvah has the potential to be an important treatment option for those who need it," she stated in a news release from Iterum Therapeutics, the drug's manufacturer.
Corey Fishman, Iterum's Chief Executive Officer, added, "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."
Dosing and Administration
The recommended dosage of Orlynvah is one tablet (500 mg sulopenem and 500 mg probenecid) taken orally every 12 hours for five days. It is advised to administer the drug with food, as food intake increases the exposure and bioavailability of sulopenem.
Safety Profile and Contraindications
While generally well-tolerated, Orlynvah is associated with some common side effects, including diarrhea (10%), nausea (4%), vomiting, abdominal pain, vulvovaginal mycotic infection, and headache. The drug is contraindicated in patients with blood dyscrasias, uric acid kidney stones, those on ketorolac tromethamine, and those with hypersensitivity to sulopenem etzadroxil, probenecid, or other beta-lactam antibacterial drugs. It is also not recommended for those who have gout as it can aggravate symptoms of gout.
