FDA issues final guidance on nicotine replacement therapy
May 30, 2023
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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested in developing nicotine replacement therapy drug products (NRT) products to help patients stop smoking.
The agency said the amount of data required to support the approval of an NRT product will depend on whether it is a generic version of an approved drug, or how similar a new drug is to an already approved product. The agency said it anticipates that most sponsors will submit these types of products under the abbreviated new drug application (ANDA) pathway or the 505(b)(2) pathway that enables sponsors to rely on the agency’s findings of safety and effectiveness for an approved product.
For investigational new drugs, FDA said that two adequate and well-controlled trials will generally be necessary.
The final guidance includes minor changes from a draft issued in February 2019. (RELATED: FDA Offers Guidance on Nicotine Replacement Therapies, Regulatory Focus 21 February 2019)
Some of these changes include a clarification that the document does not address e-cigarettes; it also provides additional clarification regarding the mode and route of administration of these products. In addition, editorial changes were made to improve clarity, said FDA’s notice announcing the guidance.
NRT drug products can be developed for smoking cessation and to reduce relapses or can target both indications.
There are several FDA-approved prescription and nonprescription NRT drug products on the market, including chewing gum and mouth sprays. Yet the agency would like to see more products on the market to “help more smokers quit.”
“Through this guidance, we are encouraging innovation in NRT development by providing detail and clarity on product development strategies,” said Theresa Michele, director of CDER’s Office of Nonprescription Drug Products (ONDP) in a statement.
The guidance covers the type of clinical studies necessary to support approval, as well as considerations for early phase clinical development, considerations for efficacy trials and developing these drugs to target pediatric populations.
To support a generic version of these drugs, sponsors must demonstrate the product has the same active ingredient, dosage form, strength, route of administration, and, with certain exceptions, labeling, to an approved referenced NRT drug product, comparative bioavailability pharmacokinetic studies (PK) to confirm that the investigational product is bioequivalent to the reference product.
For new NRT drugs that alter the delivery of nicotine, “the amount of data necessary to support approval will depend on the extent to which the new drug product is similar to an approved drug product,” FDA said.
For example, if a sponsor proposes to develop a drug product with the same route of administration as an approved NRT drug product but that alters the mode of administration such as chewing the gum product versus placing it in the cheek, the agency will not require efficacy trials, and sponsors would be only need submit a generic application demonstrating the pharmacokinetics are “sufficiently similar” to the approved product.
Yet if the sponsor proposes to develop an NRT drug product with the same route of administration as an approved product, but a different product type, such as an oral spray referencing an approved product that is chewed, sponsors could rely on a previous finding of safety. Yet they would “need to establish the product could be used effectively through at least one adequate and well-controlled clinical trial.”
For applications requiring an efficacy trial, sponsors should compare the investigational NRT drug product to placebo in a randomized, double-blind trial design. “The placebo should be indistinguishable from the investigational NRT drug product in all relevant aspects (appearance, taste, texture, etc.)” states the guidance.
FDA final guidance on nicotine replacement therapies
Announcement
FDA statement
The agency said the amount of data required to support the approval of an NRT product will depend on whether it is a generic version of an approved drug, or how similar a new drug is to an already approved product. The agency said it anticipates that most sponsors will submit these types of products under the abbreviated new drug application (ANDA) pathway or the 505(b)(2) pathway that enables sponsors to rely on the agency’s findings of safety and effectiveness for an approved product.
For investigational new drugs, FDA said that two adequate and well-controlled trials will generally be necessary.
The final guidance includes minor changes from a draft issued in February 2019. (RELATED: FDA Offers Guidance on Nicotine Replacement Therapies, Regulatory Focus 21 February 2019)
Some of these changes include a clarification that the document does not address e-cigarettes; it also provides additional clarification regarding the mode and route of administration of these products. In addition, editorial changes were made to improve clarity, said FDA’s notice announcing the guidance.
NRT drug products can be developed for smoking cessation and to reduce relapses or can target both indications.
There are several FDA-approved prescription and nonprescription NRT drug products on the market, including chewing gum and mouth sprays. Yet the agency would like to see more products on the market to “help more smokers quit.”
“Through this guidance, we are encouraging innovation in NRT development by providing detail and clarity on product development strategies,” said Theresa Michele, director of CDER’s Office of Nonprescription Drug Products (ONDP) in a statement.
The guidance covers the type of clinical studies necessary to support approval, as well as considerations for early phase clinical development, considerations for efficacy trials and developing these drugs to target pediatric populations.
To support a generic version of these drugs, sponsors must demonstrate the product has the same active ingredient, dosage form, strength, route of administration, and, with certain exceptions, labeling, to an approved referenced NRT drug product, comparative bioavailability pharmacokinetic studies (PK) to confirm that the investigational product is bioequivalent to the reference product.
For new NRT drugs that alter the delivery of nicotine, “the amount of data necessary to support approval will depend on the extent to which the new drug product is similar to an approved drug product,” FDA said.
For example, if a sponsor proposes to develop a drug product with the same route of administration as an approved NRT drug product but that alters the mode of administration such as chewing the gum product versus placing it in the cheek, the agency will not require efficacy trials, and sponsors would be only need submit a generic application demonstrating the pharmacokinetics are “sufficiently similar” to the approved product.
Yet if the sponsor proposes to develop an NRT drug product with the same route of administration as an approved product, but a different product type, such as an oral spray referencing an approved product that is chewed, sponsors could rely on a previous finding of safety. Yet they would “need to establish the product could be used effectively through at least one adequate and well-controlled clinical trial.”
For applications requiring an efficacy trial, sponsors should compare the investigational NRT drug product to placebo in a randomized, double-blind trial design. “The placebo should be indistinguishable from the investigational NRT drug product in all relevant aspects (appearance, taste, texture, etc.)” states the guidance.
FDA final guidance on nicotine replacement therapies
Announcement
FDA statement
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