Sulopenem

Orlynvah tablets treat uncomplicated urinary tract infections (uUTI) in adult women with limited antibacterial options, containing sulopenem etzadroxil and probenecid. It's FDA-approved for infections caused by specific bacteria. Common side effects include diarrhea and nausea. Not for complicated UTIs or intra-abdominal infections. Take twice daily with food.

Iterum Therapeutics experienced a 10.3% decrease in short interest to 2,260,000 shares by December 15th. The stock opened at $1.77 with a market cap of $48.70M. XTX Topco Ltd acquired a new stake, owning 0.15% of the company. HC Wainwright reiterated a 'buy' rating with a $5.00 target. Iterum focuses on developing anti-infectives, including sulopenem in Phase III trials.

In 2024, the FDA authorized new urology treatments and devices, including erdafitinib for urothelial carcinoma, cefepime/enmetazobactam for cUTIs, and the EdgeFlow UH10 bladder scanner. Other approvals covered nivolumab combinations, N-803 for bladder cancer, and innovative devices like the HYDROS robotic system and NanoKnife System.

Sulopenem/probenecid (Orlynvah) treats uncomplicated urinary tract infections in adult women, combining sulopenem etzadroxil and probenecid. Approved in the US in October 2024, it's effective against specific bacteria. Common side effects include diarrhea and nausea. Contraindicated for those with hypersensitivity to its components or certain conditions.

Sulopenem received FDA approval for treating uncomplicated urinary tract infections (uUTI), outperforming ciprofloxacin and amoxicillin/clavulanate in phase 3 trials. The antibiotic is safe and well-tolerated, offering an alternative for resistant uUTIs.

Antibiotics like nitrofurantoin, TMP-SMX, and fosfomycin are first-line treatments for UTIs. Iterum Therapeutics' ORLYNVAH, an oral antibiotic, received FDA approval for treating UTIs caused by specific bacteria, marking a significant advancement. Future UTI treatments focus on overcoming antibiotic resistance with novel therapies, including GSK’s Gepotidacin and Inmunotek’s Uromune, promising a revolution in UTI management.

Orlynvah, combining sulopenem and probenecid, was approved for uncomplicated female UTIs, showing similar efficacy to ciprofloxacin but better in ciprofloxacin-resistant cases. Dosed twice daily for 5 days, it has side effects like diarrhea and nausea. Its high cost and lack in standard sensitivity reports may limit use to multidrug-resistant cases.

Long COVID lacks specific diagnostic tests; experts call for validated biomarkers and advanced tools. Orlynvah, an oral penem, received FDA approval for treating UTIs in adult women. Avian influenza H5N1 cases rise, emphasizing One Health approach. Hepatitis B guidelines promote universal screening and vaccination. Pemivibart shows promise in reducing COVID-19 risk, with a 76% RRR over 12 months.

Iterum Therapeutics' Orlynvah approved for uUTIs, based on SURE1 and REASSURE trials. Orlynvah showed superiority over ciprofloxacin in resistant infections but not in susceptible ones, due to cipro's prolonged effect on bacterial flora. Cipro's safety issues led to its demotion as a first-line agent. REASSURE trial confirmed Orlynvah's efficacy in susceptible populations and non-inferiority overall, crucial for empiric therapy in community settings. Iterum seeks a strategic partner for Orlynvah's launch, aiming to address unmet needs and antibiotic resistance.

FDA approves oral sulopenem (Orlynvah) for UTIs, based on phase 3 trials SURE 1 and REASSURE. Sulopenem showed superiority over ciprofloxacin for resistant infections and better response than amoxicillin/clavulanate. Orlynvah aims to address antimicrobial resistance and offers a new treatment option for uUTIs.