Probenecid

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) as the first oral penem antibiotic for uncomplicated urinary tract infections (uUTIs). • Orlynvah is indicated for adult women with uUTIs caused by specific bacteria, including Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, when other oral options are limited. • Clinical trials demonstrated Orlynvah's superiority over ciprofloxacin in fluoroquinolone-resistant infections and statistical superiority to Augmentin in Augmentin-susceptible cases. • Orlynvah offers a new treatment option to combat antimicrobial resistance, particularly in quinolone-resistant organisms and ESBL-producing E. coli, potentially reducing hospitalizations.

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) for uncomplicated urinary tract infections (uUTIs) in women with limited oral treatment options. • Orlynvah is the first oral penem antibiotic approved in the US, offering a new option for uUTIs caused by specific bacteria like _Escherichia coli_ and _Klebsiella pneumoniae_. • Approval was based on two Phase 3 trials, SURE-1 and REASSURE, demonstrating non-inferiority to ciprofloxacin and amoxicillin/clavulanate, respectively, in composite response rates. • The drug, developed by Iterum Therapeutics, is administered as one tablet twice daily for five days, with common adverse reactions including diarrhea and nausea.

• Iterum Therapeutics secures FDA approval for Orlynvah (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs) in adult women. • Orlynvah is indicated for uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis, offering a new oral antibacterial option. • As the first oral penem approved in the U.S., Orlynvah addresses antimicrobial resistance and provides an alternative for patients with limited treatment options. • Iterum Therapeutics is seeking a strategic transaction for Orlynvah to maximize stakeholder value following the FDA approval.

• The FDA has approved oxycodone hydrochloride (Roxybond) for managing severe pain when alternative treatments are inadequate, addressing a critical need for effective pain relief. • Sulopenem etzadroxil and probenecid (Orlynvah) received FDA approval for uncomplicated UTIs in adult women with limited oral antibacterial options, offering a new treatment avenue. • Abrysvo, a respiratory syncytial virus (RSV) vaccine, is now approved for adults aged 18-59 at increased risk of RSV, marking the first RSV vaccine for this younger adult population. • Marstacimab-hncq (Hypmavzi) gains FDA approval as the first weekly subcutaneous therapy for hemophilia B, providing a novel prophylactic option for patients 12 and older.

• The FDA has approved Orlynvah (sulopenem etzadroxil and probenecid) for treating uncomplicated urinary tract infections (uUTIs) in adult women with limited treatment options. • Approval was based on Phase 3 trials showing Orlynvah's non-inferiority to amoxicillin/clavulanate and superiority to ciprofloxacin in treating resistant pathogens. • Orlynvah is the first oral penem antibiotic approved in the US, offering a new option for the underserved uUTI market, but concerns exist regarding potential antimicrobial resistance. • uUTIs are common in women, accounting for approximately 40 million antibiotic prescriptions annually in the US, with half of all women experiencing one in their lifetime.