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FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.
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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.
In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."