The FDA's decision not to approve Spero Therapeutics' oral antibiotic tebipenem Hbr for adults with complicated urinary tract infections (cUTI) further increases the threat of antibiotic ...

The PIVOT-PO trial was stopped early after meeting its primary end point of noninferiority to imipenem-cilastatin in treating cUTI. No new safety concerns were identified, with diarrhea and headache ...

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Results from that trial showed that 7 to 10 days of tebipenem HBr was noninferior to intravenous ertapenem in cUTI patients. But FDA officials told Spero that their analysis of the trial's ...