Sulopenem/probenecid

Last updated

Sulopenem/probenecid
Combination of
Sulopenem Penem antibacterial
Probenecid Renal tubular transport inhibitor
Clinical data
Trade names Orlynvah
License data
Routes of
administration
By mouth
ATC code
  • None
Legal status
Legal status
Identifiers
KEGG

Sulopenem/probenecid, sold under the brand name Orlynvah, is a fixed-dose combination medication used for the treatment of urinary tract infections. [1] It contains sulopenem, a penem antibacterial, as the prodrug sulopenem etzadroxil; and probenecid, a renal tubular transport inhibitor. [1]

Contents

The most common side effects include diarrhea, nausea, vaginal yeast infection, headache, and vomiting. [2]

The combination was approved for medical use to treat uncomplicated urinary tract infections in the United States in October 2024. [1] [2] [3] [4]

Medical uses

Sulopenem/probenecid is indicated for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. [1] [2]

Contraindications

Sulopenem/probenecid is contraindicated in people with a history of hypersensitivity reactions to sulopenem etzadroxil or probenecid or other beta-lactam antibacterial drugs; people with known blood dyscrasias; people with known uric acid kidney stones; and people who are also taking ketorolac tromethamine. [2]

Adverse effects

The US Food and Drug Administration (FDA) prescribing information for sulopenem/probenecid includes warnings for hypersensitivity reactions, Clostridioides difficile-associated diarrhea, and potential exacerbation of gout when given to people with a known history of gout. [2]

History

The effectiveness of sulopenem/probenecid was evaluated in two phase III controlled, randomized, double blind clinical trials (trial 1 and trial 2) which enrolled adult women with uncomplicated urinary tract infections. [2] Trial 1 (NCT05584657) was a noninferiority trial in which 2214 adult women with uncomplicated urinary tract infections were randomized and treated. [2] Sulopenem/probenecid demonstrated efficacy in participants with amoxicillin/clavulanate-susceptible pathogens with a composite response rate (combined microbiological response and clinical response) of 62% compared to a composite response rate of 55% in the amoxicillin/clavulanate group. [2] Trial 2 (NCT03354598) was a noninferiority trial in which 1660 adult women with uncomplicated urinary tract infections were randomized and treated. [2] Sulopenem/probenecid demonstrated efficacy in participants with ciprofloxacin-resistant pathogens with a composite response rate of 48% compared to a composite response rate of 33% in the ciprofloxacin group. [2] Overall, in the two trials combined, 1932 participants were treated with sulopenem/probenecid. [2] Clinical trials evaluating sulopenem/probenecid for the treatment of participants with complicated urinary tract infections and complicated intra-abdominal infections did not demonstrate effectiveness. [2]

Related Research Articles

<span class="mw-page-title-main">Amoxicillin</span> Beta-lactam antibiotic

Amoxicillin is an antibiotic medication belonging to the aminopenicillin class of the penicillin family. The drug is used to treat bacterial infections such as middle ear infection, strep throat, pneumonia, skin infections, odontogenic infections, and urinary tract infections. It is taken orally, or less commonly by either Intramuscular injection or by an IV bolus injection, which is a relatively quick intravenous injection lasting from a couple seconds to a few minutes.

<span class="mw-page-title-main">Ciprofloxacin</span> Fluoroquinolone antibiotic

Ciprofloxacin is a fluoroquinolone antibiotic used to treat a number of bacterial infections. This includes bone and joint infections, intra-abdominal infections, certain types of infectious diarrhea, respiratory tract infections, skin infections, typhoid fever, and urinary tract infections, among others. For some infections it is used in addition to other antibiotics. It can be taken by mouth, as eye drops, as ear drops, or intravenously.

<span class="mw-page-title-main">Urinary tract infection</span> Infection that affects part of the urinary tract

A urinary tract infection (UTI) is an infection that affects a part of the urinary tract. Lower urinary tract infections may involve the bladder (cystitis) or urethra (urethritis) while upper urinary tract infections affect the kidney (pyelonephritis). Symptoms from a lower urinary tract infection include suprapubic pain, painful urination (dysuria), frequency and urgency of urination despite having an empty bladder. Symptoms of a kidney infection, on the other hand, are more systemic and include fever or flank pain usually in addition to the symptoms of a lower UTI. Rarely, the urine may appear bloody. Symptoms may be vague or non-specific at the extremities of age.

<span class="mw-page-title-main">Levofloxacin</span> Antibiotic

Levofloxacin, sold under the brand name Levaquin among others, is a broad-spectrum antibiotic of the fluoroquinolone drug class. It is the left-handed isomer of the medication ofloxacin. It is used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, H. pylori, urinary tract infections, Legionnaires' disease, chronic bacterial prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis, meningitis, or pelvic inflammatory disease. It is available by mouth, intravenously, and in eye drop form.

<span class="mw-page-title-main">Azithromycin</span> Antibiotic

Azithromycin, sold under the brand names Zithromax and Azasite, is an antibiotic medication used for the treatment of several bacterial infections. This includes middle ear infections, strep throat, pneumonia, traveler's diarrhea, and certain other intestinal infections. Along with other medications, it may also be used for malaria. It is administered by mouth, into a vein, or into the eye.

<span class="mw-page-title-main">Amoxicillin/clavulanic acid</span> Combination antibiotic medication

Amoxicillin/clavulanic acid, also known as co-amoxiclav or amox-clav, sold under the brand name Augmentin, among others, is an antibiotic medication used for the treatment of a number of bacterial infections. It is a combination consisting of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor. It is specifically used for otitis media, streptococcal pharyngitis, pneumonia, cellulitis, urinary tract infections, and animal bites. It is taken by mouth or by injection into a vein.

<span class="mw-page-title-main">Ofloxacin</span> Antibiotic to treat bacterial infections

Ofloxacin is a quinolone antibiotic useful for the treatment of a number of bacterial infections. When taken by mouth or injection into a vein, these include pneumonia, cellulitis, urinary tract infections, prostatitis, plague, and certain types of infectious diarrhea. Other uses, along with other medications, include treating multidrug resistant tuberculosis. An eye drop may be used for a superficial bacterial infection of the eye and an ear drop may be used for otitis media when a hole in the ear drum is present.

<span class="mw-page-title-main">Norfloxacin</span> Chemical compound, antibiotic

Norfloxacin, sold under the brand name Noroxin among others, is an antibiotic that belongs to the class of fluoroquinolone antibiotics. It is used to treat urinary tract infections, gynecological infections, inflammation of the prostate gland, gonorrhea and bladder infection. Eye drops were approved for use in children older than one year of age.

<span class="mw-page-title-main">Prulifloxacin</span> Chemical compound

Prulifloxacin is an older synthetic antibiotic of the fluoroquinolone class undergoing clinical trials prior to a possible NDA submission to the U.S. Food and Drug Administration (FDA). It is a prodrug which is metabolized in the body to the active compound ulifloxacin. It was developed over two decades ago by Nippon Shinyaku Co. and was patented in Japan in 1987 and in the United States in 1989.

<span class="mw-page-title-main">Chronic bacterial prostatitis</span> Bacterial infection of the prostate gland

Chronic bacterial prostatitis (CBP) is a bacterial infection of the prostate gland and a form of prostatitis. It should be distinguished from other forms of prostatitis such as acute bacterial prostatitis (ABP) and chronic pelvic pain syndrome (CPPS).

<span class="mw-page-title-main">Pivmecillinam</span> Chemical compound

Pivmecillinam (INN), or amdinocillin pivoxil (USAN), sold under the brand name Selexid and Pivya among others, is an orally active prodrug of mecillinam, an extended-spectrum penicillin antibiotic. Pivmecillinam is the pivaloyloxymethyl ester of mecillinam.

<span class="mw-page-title-main">Delafloxacin</span> Chemical compound

Delafloxacin sold under the brand name Baxdela among others, is a fluoroquinolone antibiotic used to treat acute bacterial skin and skin structure infections.

<span class="mw-page-title-main">Eravacycline</span> Chemical compound

Eravacycline is a synthetic halogenated tetracycline class antibiotic by Tetraphase Pharmaceuticals. It is closely related to tigecycline. It has a broad spectrum of activity including many multi-drug resistant strains of bacteria. Phase III studies in complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI) were recently completed with mixed results. Eravacycline was granted fast track designation by the FDA and is currently available in USA.

<span class="mw-page-title-main">Gepotidacin</span> Chemical compound

Gepotidacin (INN) is an experimental antibiotic that acts as a topoisomerase type II inhibitor. It is being studied for the treatment of uncomplicated urinary tract infection and infection with Neisseria gonorrhoeae (gonorrhea), including multidrug resistant strains.

<span class="mw-page-title-main">Zuranolone</span> Medication used for postpartum depression

Zuranolone, sold under the brand name Zurzuvae, is a medication used for the treatment of postpartum depression. It is taken by mouth.

Sutimlimab, sold under the brand name Enjaymo, is a monoclonal antibody that is used to treat adults with cold agglutinin disease (CAD). It is given by intravenous infusion. Sutimlimab prevents complement-enhanced activation of autoimmune human B cells in vitro.

<span class="mw-page-title-main">Cefiderocol</span> Antibiotic

Cefiderocol, sold under the brand name Fetroja among others, is an antibiotic used to treat complicated urinary tract infections when no other options are available. It is indicated for the treatment of multi-drug-resistant Gram-negative bacteria including Pseudomonas aeruginosa. It is given by injection into a vein.

<span class="mw-page-title-main">Sulopenem</span> Chemical compound

Sulopenem (CP-70,429) is a thiopenem antibiotic derivative from the penem family, which unlike most related drugs is orally active. It was developed in Japan in the 1990s but has never been approved for medical use, however it has reached Phase III clinical trials on several occasions and continues to be the subject of ongoing research into potential applications, especially in the treatment of multiple drug resistant urinary tract infections.

Live fecal microbiota spores, sold under the brand name Vowst, is a fecal microbiota product used to prevent the recurrence of Clostridioides difficile infection.

<span class="mw-page-title-main">Urinary anti-infective agent</span> Medication for urinary tract infections

Urinary anti-infective agent, also known as urinary antiseptic, is medication that can eliminate microorganisms causing urinary tract infection (UTI). UTI can be categorized into two primary types: cystitis, which refers to lower urinary tract or bladder infection, and pyelonephritis, which indicates upper urinary tract or kidney infection. Escherichia coli is the predominant microbial trigger of UTIs, accounting for 75% to 95% of reported cases. Other pathogens such as Proteus mirabilis, Klebsiella pneumoniae, and Staphylococcus saprophyticus can also cause UTIs.

References

  1. 1 2 3 4 5 Iterum Therapeutics. "ORLYNVAH (sulopenem etzadroxil and probenecid) tablets, for oral use" (PDF). Highlights of Prescribing Information. U.S. Food and Drug Administration.
  2. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA approves new treatment for women with uncomplicated UTIs". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 25 October 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  3. "Iterum Therapeutics Receives U.S. FDA Approval of Orlynvah (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections". Iterum Therapeutics (Press release). 25 October 2024. Retrieved 25 October 2024.
  4. "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). Retrieved 28 October 2024.

Further reading