NRT Delivery Innovation Proposal In US Doesn't Deliver Expanded Indications
GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.
You may also be interested in...
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."