Pivya™ (pivmecillinam) Tablets for Uncomplicated Urinary Tract Infections Clinical Trials, Dosage, Indication, Side Effects
UTILITY therapeutics Ltd. pivmecillinam (Pivya™, Selexid, Melysin, Coactab) penicillin class antibacterial tablet approved for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. Pivmecillinam is a prodrug of the beta-lactam antibiotic mecillinam, a pivaloyloxymethyl ester of amdinocillin that is well absorbed orally but broken down to amdinocillin in the intestinal mucosa. Pivmecillinam interferes with the biosynthesis of the bacterial cell wall; however, its activity is slightly different from that of other penicillins and cephalosporins. Pivya overcomes antimicrobial resistance to resist the effects of a drug.
Pivya™ (pivmecillinam) Availability
UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam. They are expected to be available in the U.S. in 2025.
Pivya (pivmecillinam) Approvals
Pivmecillinam has been approved in Canada, Denmark, the United Kingdom, and other countries. On April 24, 2024, the U.S. Food and Drug Administration (FDA) granted approval for Pivya. The FDA application had received priority review and qualified infectious disease product designations.
Pivya (pivmecillinam) Indication
A urinary tract infection is an infection of the urinary tract that can occur at different points in the urinary tract, including the Bladder, Kidneys, Ureters, or Urethra. The uUTI treatment is recommended for first-line use in many countries and is part of the Infectious Diseases Society of America (IDSA) and the European Society for Microbiology and Infectious Diseases guidelines. A 2022 World Health Organization report found that more than 20% of Escherichia coli isolates are the most common cause of UTIs.
Pivya (pivmecillinam) Efficacy
In a phase 4 clinical trial comparing Pivya to ibuprofen, 66% of the 105 subjects who received Pivya achieved composite response compared to 22% of the 119 who received ibuprofen.
Pivya (pivmecillinam) Format
Pivmecillinam (oral) and mecillinam (IV, hospital setting) are unique classes of antibiotics with potent in vitro and in vivo activity against the most common bacteria in UTIs, including resistant strains such as ESBL-producing E coli. Mecillinam (IV) solely targets penicillin-binding protein-2 (PBP-2) in the cell wall of gram-negative bacteria.17,21 This unique mechanism leads to favorable stability against β-lactamase hydrolysis compared to other penicillins.
Pivya™ (pivmecillinam) Side Effects
Pivya's adverse effect profile is similar to that of other penicillins; the most common side effects include nausea and diarrhea.
Pivya™ (pivmecillinam) News
April 24, 2024 - “Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs.”
January 17, 2024 - UTILITY therapeutics Ltd. announced a private financing led by the AMR Action Fund.
Pivya™ (pivmecillinam) Clinical Trials
PIVYA™ (pivmecillinam, oral) research comprises six clinical studies (phase 3) supporting the efficacy. In the clinical trial comparing pivmecillinam to another oral antibacterial drug, 72% of the 127 participants who received pivmecillinam achieved composite response compared to 76% of the 132 who received the comparator drug.
