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Public Assessment Report Scientific Discussion Normodiab Tablets 80 Mg Gliclazide IS/H/0145/001/DC

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Public Assessment Report Scientific Discussion Normodiab Tablets 80 Mg Gliclazide IS/H/0145/001/DC Public Assessment Report Scientific discussion Normodiab tablets 80 mg Gliclazide IS/H/0145/001/DC This module reflects the scientific discussion for the approval of Nemodiab. The procedure was finalised at 13 December 2009. For information on changes after this date please refer to the module ‘Update’. I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Normodiab tablets 80 mg from Actavis. The product is indicated for non- insulin dependent diabetes mellitus. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. Gliclazide is a second-generation sulphonylurea compound that is used in the treatment of non- Insulin-Dependent Diabetes Mellitus (NIDDM) where dietary regulation is insufficient. The primary effect of sulphonylurea-like drugs is to potentiate glucose-stimulated insulin release from functioning pancreatic islet-ß-cells by induction of a decrease in potassium efflux from these cells. ATC code: A 10 BB 09. Gliclazide is indicated for the treatment of non insulin-dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose. No discussions were held with CMDh during the procedure. II. QUALITY ASPECTS II.1 Introduction The drug product is a conventional tablet with 80 mg of the active substance gliclazide. The tablets are white, flat, round, bevelled-edged and with score on both faces. The tablet diameter is 8.0 mm and "GZ" is engraved in either side of a central break line on one face. Normodiab tablet contain the following excipients: Cellulose microcrystalline (type 101), pregelatinised maize starch, maize starch, stearic acid and magnesium stearate. The tablets are packed in opaque PVC/Aluminium blisters. II.2 Drug Substance The drug substance is Gliclazide, an established active substance of chemical origin. It is monographed in the European Pharmacopoeia (n°1524). Gliclazide is a white or almost white powder, which is practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in acetone, slightly soluble in ethanol (96%). The active substance specification includes relevant tests and the acceptance limits have been appropriately justified. The analytical methods applied are suitably described and validated as demonstrated with compliance to the Ph.Eur. as CEP for the active substance confirms. Stability studies have been conducted and the data provided is sufficient to support the proposed retest period. II.3 Medicinal Product The development of the drug product formulation is well described. The excipients used in the product are all standard in the manufacture of tablets and are compliant with European Pharmacopoeia (or equivalent) requirements. PAR Scientific discussion 2/4 The manufacturing process has been sufficiently described and critical steps identified. Results from the process validation studies confirm that the process is under control and ensure both batch to batch reproducibility and compliance with the product specification. The tests and limits in the finished products specifications are considered appropriate to control the quality of the finished product in relation to its intended purpose. Comparative in vitro dissolution profiles of the generic product and the reference product support the claim for similarity. Stability studies under ICH conditions have been performed in the commercial packaging and data presented support the shelf life claimed in the SPC; 2 years. Store below 30°C. The pharmaceutical quality of Normodiab has been adequately shown. II.4 Discussion on chemical, pharmaceutical and biological aspects Information on development, manufacture and control of active substance and medicinal product has been presented in a satisfactory manner. The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics. III. NON-CLINICAL ASPECTS A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has been provided, which is based on up-to-date and adequate scientific literature. The overview justifies why there is no need to generate additional non-clinical pharmacology, pharmacokinetics and toxicology data. The non-clinical aspects of the SmPC are in line with the SmPC of the reference product. The impurity profile has been discussed and was considered acceptable. Therefore, no further non-clinical studies are required. Environmental risk assessment Since Normodiab is intended for generic substitution, this will not lead to an increased exposure to the environment. An environmental risk assessment is therefore not deemed necessary. IV. CLINICAL ASPECTS IV.1 Introduction Abridged applications avoid the need for repetitive tests on animals and humans apart from a conduction of a bioequivalence study to confirm that the applied product is bioequivalent to the reference medicinal product. The clinical overview on the clinical pharmacology, efficacy and safety is adequate. IV.2 Pharmacokinetics A randomized, open label, two treatment, two period, two sequence, single dose, crossover, bioequivalence study of Gliclazide 80 mg tablets of Actavis Group PTC ehf, Iceland and Diamicron® (Gliclazide) 80 mg tablets of Servier Laboratories Limited, UK, in healthy adult subjects, under fasting conditions. The Protocol code was 1391/08, dated March 4, 2008. Gliclazide is extensively absorbed by the gastrointestinal tract, but absorption rate varies considerably, and individuals can be classified as slow or fast absorbers. PAR Scientific discussion 3/4 A bioequivalence trial was carried out with a 80-mg dose on 26 male healthy volunteers aged 19-32 years. The mean AUC0-t for the gliclazide test product was 75,2735 +/- 24,2956 µg/h/ml and for the reference product, it was 72,4197+/-23,2150 µg/h/ml. The mean Cmax for the gliclazide test product and reference product were 5,9485+/-0,9531 µg/ml and 5,1138+/-0,8392 µg/ml respectively. The mean t1/2 for the Gliclazide test product was 13,4 h and for the reference product 13,22 h. Conclusion on bioequivalence studies: Based on the submitted bioequivalence study, Gliclazide 80 mg tablets are considered bioequivalent with Diamicron® 80 mg tablets. IV.3 Pharmacodynamics No new pharmacodynamic studies were presented and no such studies are required for this application. IV.4 Clinical efficacy No new clinical efficacy studies were presented and no such studies are required for this application. IV.5 Clinical safety No new clinical safety studies were presented and no such studies are required for this application. IV.6 Discussion on the clinical aspects Normodiab is a generic to Diamicron. Abridged applications avoid the need for repetitive tests on animals and humans apart from a conduction of a bioequivalence study. The application contains an adequate review of published clinical data and the bioequivalence has been shown between Normodiab and Diamicron. V. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Based on the review of the data on quality, safety and efficacy, the risk-benefit ratio for the application for Normodiab in the treatment of non-insulin dependent diabetes mellitus, is considered positive and marketing authorisation can be recommended. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. There was no discussion in CMDh. The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. User consultation 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 Gliclazide 30 mg modified-release tablets from Actavis. The bridging report submitted by the applicant has been found acceptable. PAR Scientific discussion 4/4 .
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