FDA Offers Guidance on Nicotine Replacement Therapies

Regulatory NewsRegulatory News | 21 February 2019 |  By 

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations to drugmakers looking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.
The 19-page draft guidance comes after FDA held a public consultation on its approach to evaluating NRT products in November 2017 and a public hearing on the matter in January 2018.
FDA says the draft guidance “takes into consideration the feedback received and is intended to serve as a focus for continued discussions among the agency, pharmaceutical sponsors, the academic community, and the public.”
There are currently several types of NRT products on the market, including skin patches, chewing gum and lozenges intended to help smokers wean themselves off cigarettes.
“While nicotine keeps smokers addicted, it’s the smoke and the 7,000 chemicals contained in it that causes the disease and death. That’s why a key element of our comprehensive plan to significantly reduce tobacco-related disease and death is to recognize that nicotine, while highly addictive, is delivered through products along a continuum of risk with combustible cigarettes at one end, and NRT products at the other,” FDA Commissioner Scott Gottlieb said.
The guidance covers a range of topics on drug development and clinical trial design for new NRT products as well as for generic and new versions of existing NRT products.
The guidance also discusses alternative treatment regimens such as those that begin before a patient quits, help a patient gradually reduce smoking over time or involve the use of multiple NRT products as part of a single regimen.
Additionally, the guidance provides recommendations on adding information to an already approved NRT product’s label on secondary endpoints, such as reducing the urge to smoke, relief of cue-induced cravings or relief of withdrawal symptoms in smokers who are not trying to quit but must temporarily abstain from smoking.
For sponsors looking to develop over-the-counter NRT products, FDA notes that “it is often not possible to answer all regulatory questions in a single trial, and additional sequential steps may be needed” to demonstrate the product can be used effectively without a doctor’s supervision.
FDA also notes that it will regulate combination products that involve a device constituent, such as an electronic cigarette used to deliver an NRT product, as drugs to be reviewed by the Center for Drug Evaluation and Research.
FDA, Draft Guidance, Federal Register Notice


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