Pivya™ (pivmecillinam) Tablets for Uncomplicated Urinary Tract Infections (UTI) 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 by killing bacteria to resist the effects of a drug.
On April 24, 2024, the U.S. Food and Drug Administration (FDA) approved Pivya tablets for treating female adults with uncomplicated UTIs. The New Drug Application submitted to the FDA comprised six clinical studies supporting the efficacy and 12 clinical studies supporting the safety of PIVYA. Through a sequence of interactions with the FDA, UTILITY has reanalyzed all available data according to the FDA 2019 uncomplicated UTI guidance. The clinical data support first-line positioning due to its benign safety profile and consistent efficacy.
In the clinical trial comparing Pivya to placebo, 62% of the 137 subjects who received Pivya achieved the composite response compared to 10% of the 134 who received placebo. In the clinical trial comparing Pivya to another oral antibacterial drug, 72% of the 127 subjects who received Pivya achieved composite response compared to 76% of the 132 who received the comparator drug. In the 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 was granted FDA Priority Review and Qualified Infectious Disease Product Designations.
UTILITY is a privately held pharmaceutical development company. At UTILITY, we are committed to providing reliable and transparent information about our business, development programs, and regulatory progress in a clear and timely manner. For more information, please contact Tom Hadley, President and CEO. Email: [email protected]
Pivya™ (pivmecillinam) Availability
UTILITY has exclusive U.S. commercial rights to two European-approved antibiotics, pivmecillinam and mecillinam. Pivya is available in Europe and is expected to be available in the U.S. in 2025. Pivmecillinam has been approved in Canada, Denmark, the United Kingdom, and other countries.
Pivya (pivmecillinam) Indication
In the U.S., UTIs are a severe public health problem that is becoming increasingly more difficult to manage. A UTI 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. It 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. Patients should not use Pivya if they have a known history of severe hypersensitivity to Pivya or other beta-lactam antibacterial drugs. Patients should also not use Pivya if they have primary or secondary carnitine deficiency resulting from inherited disorders of mitochondrial fatty acid oxidation and carnitine metabolism or if they suffer from porphyria. Pivya comes with specific warnings and precautions, such as hypersensitivity reactions, severe cutaneous adverse reactions, carnitine depletion, Clostridioides difficile-associated diarrhea, and interference with a newborn screening test for isovaleric acidemia, a rare metabolic disorder.
Pivya™ (pivmecillinam) News
April 24, 2024 - “Uncomplicated UTIs are a prevalent 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 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.