Recovering from a complete response letter (CRL) in 2018, Trevena Inc. resubmitted its NDA for oliceridine, branded Olinvyk. On Aug. 7, the drug received agency approval for managing moderate to severe acute pain in adults when the pain is severe enough to require an I.V. opioid and for patients whose alternative treatments are inadequate. The FDA has now approved a total of 34 new molecular entities (NMEs) so far this year. That total is well ahead of the 18 NMEs that were approved at this time in 2019 even though the FDA suggested back in May that it might have trouble meeting PDUFA dates due to the resources it needed to devote to the COVID-19 pandemic.
The costs associated with navigating a new therapeutic through the regulatory process to final approval and subsequent marketing continue to rise despite industry's collective efforts to speed up the process of drug discovery and development in order to rein in those burgeoning expenses.