Public Assessment Report UKPAR. Galpharm Nicotine Replace 2 mg and 4 mg Gum. (Nicotine resinate) UK Licence No: PL 12063/

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1 Public Assessment Report UKPAR Galpharm Nicotine Replace 2 mg and 4 mg Gum (Nicotine resinate) UK Licence No: PL 12063/ Wrafton Laboratories Limited 1

2 LAY SUMMARY Galpharm Nicotine Replace 2 mg and 4 mg Gum (Nicotine resinate) This is a summary of the Public Assessment Report (PAR) for Galpharm Nicotine Replace 2 mg and 4 mg Gum (PL 12063/ ). These medicinal products will be referred to as Nicotine Gum in the remainder of this summary, for ease of reading. This summary explains how Nicotine Gum was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Nicotine Gum. For practical information about using Nicotine Gum, patients should read the package leaflets or contact their doctor or pharmacist. What is Nicotine Gum and what is it used for? Nicotine Gum is a generic medicine. This means that Nicotine Gum is similar to reference medicines authorised in the European Union (EU) called Nicorette 2 mg and 4 mg Freshmint Gum (McNeil Products Ltd). Nicotine Gum can reduce the urge to smoke by providing some of the nicotine previously inhaled from cigarettes. This type of treatment is called Nicotine Replacement Therapy (NRT). Nicotine Gum can be used to stop smoking completely by replacing all of the cigarettes smoked. However, it can also be used to help: cut down the number of cigarettes smokers smoke, for example, if smokers are unable to stop smoking completely or want to replace certain cigarettes in situations where smokers do not wish to smoke to avoid harming others, such as children or family in situations where smokers are unable to smoke, such as at work or on public transport. If possible, when giving up smoking, this medicated chewing gum should be used with a stop smoking behavioural support programme which will increase the chances of success. Nicotine Gum can also be used to help pregnant or breast-feeding women to stop smoking. Using NRT is safer for women and their baby than continuing to smoke. It is always better to stop smoking completely. Smoking is harmful and has no health benefits. NRT products like this medicated chewing gum can help smokers stop smoking. Any risks or possible side effects from NRT are much less than the proven dangers of continuing to smoke, because the chewing gum does not contain the tar, carbon monoxide or other toxic chemicals in cigarette smoke. Some people worry that, when they have stopped smoking, they may become dependent on NRT instead. This is very rare, and if it were to happen it is still safer than continuing to smoke. It is also an easier habit to break. How does Nicotine Gum work? Nicotine Gum contains nicotine resin which when chewed, releases nicotine which is absorbed through the lining of the mouth. This nicotine relieves some of the cravings and unpleasant withdrawal symptoms, such as feeling ill, anxious and irritable, that smokers frequently feel when they try to give up smoking or cut down the number of cigarettes smoked. How is Nicotine Gum used? 2

3 This is a special type of gum and is not like ordinary chewing gum. Smokers should chew 1 piece of medicated chewing gum for about 30 minutes with regular pauses. It is important to chew the medicated chewing gum slowly and with regular pauses to allow the nicotine to be taken in through the lining of the mouth, and also so that the nicotine is not released too quickly. The chewing gum must be disposed carefully after 30 minutes. The following instructions for use depend on whether smokers are stopping smoking completely, cutting down the number of cigarettes they smoke per day or if smokers are going without cigarettes for a short time The 2 mg chewing gums are suitable for people who smoke 20 or fewer cigarettes per day, or by people who are heavier smokers who are reducing the number and strength of the product they are using. The 4mg chewing gums are suitable for people who smoke 20 or more cigarettes per day. The chewing gum may not be suitable for use if smokers have false teeth, as it could stick to them and more rarely, damage the dentures. The recommended dose of gums in adults and young people aged 12 years and over who smoke 20 cigarettes or less is one 2mg gum, as required, to manage cravings. Smokers should not use more than one piece of chewing gum at a time and must not exceed more than 15 gums per day. The recommended dose of gums in adults and young people aged 12 years and over who smoke 20 cigarettes or more is one 4mg gum as required to manage cravings. Smokers should not use more than one piece of chewing gum at a time and must not exceed more than 15 gums per day. Nicotine Gum is a General Sale List (GSL) medicine For further information on how Nicotine Gum is used, refer to the Summaries of Product Characteristics or package leaflets available on the MHRA website. What benefits of Nicotine Gum have been shown in studies? As Nicotine Gum is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference products, Nicorette 2 mg and 4 mg Freshmint Gum (McNeil Products Ltd). Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the possible side effects of Nicotine Gum? Because Nicotine Gum is a generic medicine and is bioequivalent to Nicorette 2 mg and 4 mg Freshmint Gum, its benefits and possible side effects are taken as being the same as those of the reference medicines. For the full list of all side effects reported Nicotine Gum, see section 4 of the package leaflets available on the MHRA website. Why was Nicotine Gum approved? It was concluded that, in accordance with EU requirements, Nicotine Gum has been shown to have comparable quality and to be bioequivalent to Nicorette 2 mg and 4 mg Freshmint Gum. Therefore, the MHRA decided that, as for Nicorette 2 mg and 4 mg Freshmint Gum, the benefits of Nicotine Gum is greater than their risks and recommended that it can be approved for use. 3

4 What measures are being taken to ensure the safe and effective use of Nicotine Gum? A risk management plan has been developed to ensure that Nicotine Gum is used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics and the package leaflets for Nicotine Gum, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously as well. Other information about Nicotine Gum Marketing Authorisations were granted in the UK on 11 December The full PAR for Nicotine Gum follows this summary. For more information about treatment with Nicotine Gum, read the package leaflets, or contact your doctor or pharmacist. This summary was last updated in January

5 TABLE OF CONTENTS I Introduction Page 6 II Quality aspects Page 7 III Non-clinical aspects Page 8 IV Clinical aspects Page 9 V User consultation Page 12 VI Overall conclusion, benefit/risk assessment and recommendation Page 12 Table of content of the PAR update Page 17 5

6 I INTRODUCTION Based on the review of the data on quality, safety and efficacy, the Medicines and Healthcare products Regulatory Agency (MHRA) granted Wrafton Laboratories Limited, Marketing Authorisations for the medicinal products Galpharm Nicotine Replace 2 mg and 4 mg Gum (PL 12063/ ) on 11 December These products are available as General sale List (GSL) medicines and are indicated for the relief and/or prevention of nicotine withdrawal symptoms including cravings associated with smoking cessation. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them. Nicotine 2 mg and 4 mg Gum are indicated in pregnant and lactating women making a quit attempt. The applications were submitted under Article 10(1) of Directive 2001/83/EC, as amended, crossreferring to Nicorette Freshmint 2 mg and 4 mg Freshmint Gum, PL 15513/ , (McNeil Products Ltd), which were first authorised in the UK on 12 February The German reference product has also been used in the bioequivalence studies. The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicotine 2 mg and 4 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis. Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt. Two bioequivalence studies were submitted to support these applications comparing the applicant s test products Nicotine 2 mg and 4 mg Mint Gum (Fertin Pharma S.A) with the reference products, Nicorette 2 mg and 4 mg Freshmint Gum (McNeil Consumer Healthcare GmbH, Germany) in human smoker subjects under fasting conditions. The applicant has stated that the bioequivalence studies were conducted in compliance with Good Clinical Practice (GCP) requirements. With the exception of the bioequivalence studies, no new non-clinical or clinical data were submitted, which is acceptable given that these applications were based on being generic medicinal products of the originator products that have been in clinical use for over 10 years. No new or unexpected safety concerns arose during the review of information provided by the Marketing Authorisation Holder and it was, therefore, judged that the benefits of taking Galpharm Nicotine Replace 2 mg and 4 mg Gum outweigh the risks and Marketing Authorisations were granted. 6

7 II QUALITY ASPECTS II.1 Introduction Each piece of chewing gum contains 2 mg or 4 mg nicotine, equivalent to 13.2 mg and 26.5 mg nicotine resinate respectively, as active ingredient. The excipients present are gum base (containing butylated hydroxytoluene [E321]), calcium carbonate, xylitol, sodium carbonate anhydrous, acesulfame potassium, sucralose, peppermint, coolmix, L-menthol, talc, maltitol (E965), titanium dioxide, maltitol liquid, carnauba wax and sodium hydrogen carbonate (2mg strength only). All excipients comply with their respective European Pharmacopoeia monographs with the exception of gum base, peppermint, L-menthol and coolmix which comply with satisfactory in-house specifications. Satisfactory Certificates of Analysis have been provided for all excipients. The chewing gums are packed in blisters with 10 or 12 pieces of chewing gum per blister. The blister pack is made of polyvinylchloride (PVC)/polyvinyldichloride (PVdC) thermoformed blister cards, sealed with aluminium foil. The pack sizes are 10, 12, 20, 24, 30, 36, 48, 50, 80, 96 and 108 pieces of chewing gum. Not all pack sizes may be marketed. Satisfactory specifications and Certificates of Analysis have been provided for all packaging components. II.2. Drug Substance INN: Nicotine Resinate Chemical name(s): 2-propenoic acid, 2-methyl-, polymer with divinylbenzene, complex with 1- methyl-2-(3-pyridyl) pyrrolidine Metacrylic acid polymer with divinylbenzene, complex with nicotine-s-3-(1- methyl-2-pyrrolidinyl) pyridine. Structural formula: Nicotine and ion exchange resin is a complex with the following structure: Molecular formula: Appearance: Solubility: C 10 H 14 N 2 (C 4 H 6 O 2 ) X (C 10 H 10 ) Y white to slightly yellowish powder, hygroscopic Nicotine resinate is practically insoluble in water, but nicotine is released from the complex, when suspended in water with cations. Nicotine resinate is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance, nicotine resinate, are covered by a European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificate of Suitability. II.3. Medicinal Product Pharmaceutical Development The objective of the development programme was to formulate safe, efficacious medicated chewing gum containing 2 mg and 4 mg nicotine resinate that are bioequivalent to the reference products Nicorette 2 mg and 4 mg Freshmint Gum (McNeil Products Ltd). A satisfactory account of the pharmaceutical development has been provided. 7

8 Comparative in-vitro dissolution profiles have been provided for the proposed and originator products. Manufacture of the products Satisfactory batch formulae have been provided for the manufacture of the products, along with an appropriate account of the manufacturing processes. The manufacturing process has been validated and has shown satisfactory results. Process validation data on commercial scale batches have been provided. The results are satisfactory. Finished Product Specifications The finished product specifications are acceptable. The test methods have been described and have been adequately validated. Batch data have been provided that comply with the release specifications. Certificates of Analysis have been provided for all working standards used. Stability of the Products Finished product stability studies were performed in accordance with current guidelines on batches of finished product in the packaging proposed for marketing. The data from these studies support a shelflife of 30 months with a storage condition Do not store above 25ºC and Keep blister in outer carton to protect from light. Suitable post approval stability commitments have been provided to continue stability testing on batches of finished product. II.4 Discussion on chemical, pharmaceutical and biological aspects There are no objections to the approval of these applications from a pharmaceutical point of view. III NON-CLINICAL ASPECTS III.1 Introduction As the pharmacodynamic, pharmacokinetic and toxicological properties of nicotine resinate are well-known, no new non-clinical studies are required and none have been provided. An overview based on the literature review is, thus, appropriate. The applicant s non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the relevant non-clinical pharmacology, pharmacokinetics and toxicology. III.2 Pharmacology Not applicable for these product type. Refer to section III.1; Introduction detailed above. III.3 Pharmacokinetics Not applicable for these product type. Refer to section III.1; Introduction detailed above. III.4 Toxicology Not applicable for these product type. Refer to section III.1; Introduction detailed above. III.5 Environmental Risk Assessment (ERA) Since these products are intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. III.6 Discussion on the non-clinical aspects 8

9 No new non-clinical studies were conducted, which is acceptable given that the applications were based on being generic medicinal products of originator products that have been licensed for over 10 years. There are no objections to the approval of these applications from a non-clinical point of view. IV CLINICAL ASPECTS IV.1 Introduction The clinical pharmacology of nicotine resinate is well-known. With the exception of data from the bioequivalence studies detailed below, no new pharmacodynamic or pharmacokinetic data are provided and none are required for these applications. No new efficacy or safety studies have been performed and none are required for this type of applications. A comprehensive review of the published literature has been provided by the applicant, citing the well-established clinical pharmacology, efficacy and safety of nicotine resinate. IV.2 Pharmacokinetics In support of these applications, the applicant has submitted two bioequivalence studies under fasting conditions comparing the test products Nicotine Peppermint 2 mg and 4 mg medicated chewing gum (Fertin Pharma A/S which are equivalent to Galpharm Nicotine Replace 2 mg Gum, with the reference products, Nicorette 2 mg Freshmint medicated chewing gum (McNeil Consumer Healthcare GmbH, Germany). Study 1 This was an open label, single dose, randomised, two period, two sequence, cross-over bioequivalence study comparing the pharmacokinetics of the applicant s test product Nicotine Peppermint 2 mg medicated chewing gum (Fertin Pharma A/S), versus the reference product, Nicorette 2 mg Freshmint medicated chewing gum (McNeil Consumer Healthcare GmbH, Germany), in 54 healthy adult smokers under fasting conditions. Following dosing, chewed gum cuds were collected to be analysed. For each subject a total of 19 blood samples were collected from the start of chewing (dosing) over the following 24 hours. Samples were collected at 5 minutes, 10 minutes and 15 minutes before dosing and at 5 minutes, 10 minutes, 20 minutes and 30 minutes, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 3.00, 6.00, 9.00, 12.00, and hours post dose during both periods. Post-dose, 4 readings of exhaled carbon monoxide level measurement and oral cavity examination were taken as per randomisation. The two treatment days were separated by a washout period of 9 days. Results Ratio and 90% Confidence Intervals of Test versus Reference for nicotine (N=54) 9

10 Conclusion The 90% confidence intervals for C max and AUC were within the acceptance criteria of %. Bioequivalence has been shown for the test formulation (Nicotine Peppermint 2 mg medicated chewing gum) and the reference formulation (Nicorette 2 mg Freshmint medicated chewing gum) under fasting conditions. Study 2 This was an open label, single dose, randomised, two period, two sequence, cross-over bioequivalence study comparing the pharmacokinetics of the applicant s test product Nicotine Peppermint 4 mg medicated chewing gum (Fertin Pharma A/S), versus the reference product, Nicorette 4 mg Freshmint medicated chewing gum (McNeil Consumer Healthcare GmbH, Germany), in 40 healthy adult smokers under fasting conditions. Following dosing, chewed gum cuds were collected to be analysed. For each subject a total of 19 blood samples were collected from the start of chewing (dosing) over the following 24 hours. Samples were collected at 15 minutes, 10 minutes and 5 minutes before dosing and at 5 minutes, 10 minutes, 20 minutes and 30 minutes, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 3.00, 6.00, 9.00, 12.00, and hours post dose during both periods. Post-dose, 4 readings of exhaled carbon monoxide level measurement and oral cavity examination were taken as per randomisation. The two treatment days were separated by a washout period of 9 days. Results Ratio and 90% Confidence Intervals of Test versus Reference for nicotine (N=40) Conclusion The 90% confidence intervals for C max and AUC were within the acceptance criteria of %. Bioequivalence has been shown for the test formulation (Nicotine Peppermint 4 mg medicated chewing gum) and the reference formulation (Nicorette 4 mg Freshmint medicated chewing gum) under fasting conditions. IV.3 Pharmacodynamics No new pharmacodynamic data were submitted and none were required for applications of this type. IV.4 Clinical efficacy No new efficacy data were submitted and none were required for applications of this type. IV.5 Clinical safety No new efficacy data were submitted and none were required for applications of this type. IV.6 Risk Management Plan (RMP) The Marketing Authorisation Holder (MAH) has submitted a risk management plan, in accordance with 10

11 the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Galpharm Nicotine Replace 2 mg and 4 mg Gum. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, is listed below: 11

12 IV.7 Discussion on the clinical aspects With the exception of the bioequivalence studies, no new clinical studies were conducted, which is acceptable given that the applications were based on being generic medicinal products of originator products that have been licensed for over 10 years. Bioequivalence has been demonstrated between the applicant s products Nicotine Peppermint 2 mg and 4 mg medicated chewing gum and the reference products Nicorette 2 mg and 4 mg Freshmint medicated chewing gum (McNeil Consumer Healthcare GmbH) under fasting conditions. The grant of Marketing Authorisations is recommended for these applications. V User consultation For Galpharm Nicotine Replace 2 mg and 4 mg Gum a user consultation with target patient groups on the package information leaflet (PIL) has been performed on the basis of a bridging report making reference to Nicotine 4 mg Lozenges (PL 12063/0069). The bridging report submitted by the applicant is acceptable. VI Overall conclusion, benefit/risk assessment and recommendation The quality of the products is acceptable, and no new non-clinical or clinical concerns have been identified. Bioequivalence has been demonstrated between the applicant s products and the reference products. Extensive clinical experience with nicotine resinate is considered to have demonstrated the therapeutic value of the compound. The benefit / risk assessment is, therefore, considered to be positive. 12

13 Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labels In accordance with Directive 2010/84/EU the Summaries of Product Characteristics (SmPC) and Patient Information Leaflets (PIL) for products granted Marketing Authorisations at a national level are available on the MHRA website. The approved labelling for Galpharm Nicotine Replace 2 mg and 4 mg Gum is presented below: 13

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17 Table of content of the PAR update Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II variations, PSURs, commitment Date Application Scope Outcome submitted type 17

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