Wider Options In FDA's NRT Clinical Trial Guidance, Approval Path Still Narrow
FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.
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Without mentioning NRT space, FDA’s acceptance of one vape device and two replacement nicotine cartridges as tobacco products might reignite interest in proposals for ENDS or other novel products to be approved for smoking cessation claims. To gain clearance as tobacco products, the ENDS were shown to provide a benefit similar to efficacies required for an NRT.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.