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The US Food and Drug Administration (FDA) on Thursday released a draft directive containing recommendations to drug manufacturers seeking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.
The 19-page draft directive came after the FDA held a public consultation on its approach to badessing NRT products in November 2017 and a public hearing on the issue in January 2018.
According to the FDA, the draft directive "takes into account the comments received and is intended to serve as a basis for ongoing discussions between the agency, pharmaceutical sponsors, the academic community and the public".
There are currently several types of TNS on the market, including skin patches, chewing gums and lozenges to help smokers quit smoking.
"If nicotine keeps smokers addicted, it's the smoke and the 7,000 chemicals it contains that cause disease and death. That is why one of the key elements of our overall plan to significantly reduce the number of tobacco-related deaths and illnesses is to recognize that nicotine, although highly addictive, is delivered by the public. products with a continuum of risk, with combustible cigarettes at one end and TNS products at the other, "said FDA Commissioner Scott Gottlieb.
The guidelines cover a range of topics on drug development and clinical trial design for new TRN products as well as generic and new versions of existing TRN products.
The instructions also deal with alternative treatment regimens such as those that begin before the patient leaves, help the patient gradually reduce smoking over time, or involve the use of multiple NRT products as part of the treatment plan. a unique treatment regimen.
In addition, the guide provides recommendations on adding information to the label of an NRT product already approved on secondary evaluation criteria, such as reducing the number of times that the product has been approved. craving, relieving cravings induced by withdrawal signs or symptoms in smokers who are not trying to quit but need to quit temporarily. refrain from smoking.
For promoters seeking to develop over-the-counter NRT products, the FDA notes that it is "often impossible to answer all regulatory questions in a single trial and that additional sequential steps may be required" to demonstrate that the product can be used effectively without problem. doctor's supervision.
The FDA also states that it will regulate combination products containing a component of the device, such as an electronic cigarette used to deliver a TRN product, as drugs to be reviewed by the Center for Drug Evaluation and Research.
FDA, Draft Guidance, Federal Register Notice
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