Advisory committee meeting for oral sulopenem occurring September 9, 2024
The advisory committee meeting will discuss the potential approval of oral sulopenem etzadroxil/probenecid tablets for treating urinary tract infections in women aged 18 years and older.
Advisory committee meeting for oral sulopenem occurring September 9, 2024 | Image Credit: © aerogondo - © aerogondo - stock.adobe.com.
On September 9, 2024, an advisory committee meeting will take place to discuss a new drug application (NDA) for oral sulopenem etzadroxil/probenecid tablets.1
The sulopenem tablets, which include 500 mg sulopenem etzadroxil and 500 mg probenecid, are being developed by Iterum Therapeutics US Ltd., to treat urinary tract infections (UTI) linked to susceptible bacteria in women aged 18 years and older. The meeting will allow advisory committees to help the FDA come to a decision on the tablet’s approval.1
UTIs are one of the most common bacterial infections reported in adult women, with approximately 15 million related emergency room and office visits and over 30 million uncomplicated urinary tract infections (uUTI) treated in the United States per year.2 Of those infections, 30% are caused by a quinolone non-susceptible organism.
The safety and efficacy of sulopenem tablets were proven in the phase 3 REASSURE trial, a non-inferiority trial comparing oral sulopenem with Augmentin. Non-inferiority was determined by the lower bound of the 95% confidence interval being above -10%.2
REASSURE was a randomized, multicenter, double-blind, double dummy, controlled study.3 Eligibility criteria included being aged at least 18 years and having between 24 and 96 hours of urinary symptoms associated with a UTI.
Additionally, at least 2 symptoms of uUTI were necessary for inclusion. These symptoms included urinary urgency, urinary frequency, suprapubic pain, and pain or burning on micturition.3
Exclusion criteria included symptoms of acute pyelonephritis, antibacterial drug therapy receipt, concurrent non-study treatment use, anatomical abnormality of the urinary tract, ongoing urinary retention, neurogenic bladder, long-term care facility resident, instrumentation of urinary tract in the past 30 days, and foreign material in the urinary tract.
Participants were randomized 1:1 to receive either oral sulopenem or Augmentin twice per day for 5 days. Overall success was measured on day 12 as the combined clinical and microbiologic success.3
Results indicated noninferiority from sulopenem when compared to Augmentin, with a treatment difference of 6.7% for overall response, 0.6% for clinical success, and 8.5% for microbiological success.2 These rates were 61.7%, 77.3%, and 75.2%, respectively for sulopenem and 55%, 76.7%, and 66.7%, respectively for Augmentin.
Alongside similar efficacy data, sulopenem and Augmentin displayed similar tolerance results, with both therapies having a rate of discontinuations caused by adverse events below 1%. There were no serious adverse events (SAEs) reported in patients receiving sulopenem, while 5 SAEs were reported in those taking Augmentin.2
No drug-related SAEs were reported from either sulopenem or Augmentin. Additionally, oral sulopenem had a similar safety profile as those observed in prior phase 3 trials. There were no new safety signals except those linked to β-lactams.2
"In addition to achieving non-inferiority for the primary endpoint of overall response at the time of care visit in the Augmentin-susceptible population in the REASSURE trial, the lower limit of the 95% confidence interval around the treatment difference was above zero, indicating statistical superiority of oral sulopenem over Augmentin,” said Sailaja Puttagunta, MD, chief medical officer of Iterum.
Following the positive phase 3 trial results, the FDA acknowledged receipt of a resubmitted NDA for sulopenem.4 With a class 2 complete response, the NDA resubmission was given a 6-month review period, leading the FDA to assign a PDUFA action date of October 25, 2024.
References
- September 9, 2024: Meeting of the antimicrobial drugs advisory committee meeting announcement. US Food and Drug Administration. September 4, 2024. Accessed September 6, 2024. https://www.fda.gov/advisory-committees/advisory-committee-calendar/september-9-2024-meeting-antimicrobial-drugs-advisory-committee-meeting-announcement-09092024#event-information
- Iterum Therapeutics announces positive topline results from its phase 3 REASSURE clinical trial of oral sulopenem in uncomplicated urinary tract infections. Iterum Therapeutics. January 30, 2024. Accessed September 6, 2024. https://www.prnewswire.com/news-releases/iterum-therapeutics-announces-positive-topline-results-from-its-phase-3-reassure-clinical-trial-of-oral-sulopenem-in-uncomplicated-urinary-tract-infections-302047483.html
- Oral sulopenem versus amoxicillin/clavulanate for uncomplicated urinary tract infection in adult women (REASSURE). ClinicalTrials. Accessed September 6, 2024. https://clinicaltrials.gov/study/NCT05584657
- Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections. Iterum Therapeutics. May 31, 2024. Accessed September 6, 2024. https://www.iterumtx.com/news/press-releases/detail/124/iterum-therapeutics-receives-fda-acceptance-of-resubmission
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