Public Assessment Report. Scientific discussion. Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets. (Amisulpride) DK/H/2386/ /DC

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1 Public Assessment Report Scientific discussion Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets (Amisulpride) DK/H/2386/ /DC 21 January 2016 This module reflects the scientific discussion for the approval of Aktiprol. The procedure was finalised on 20 April For information on changes after this date please refer to the module Update.

2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets, from Medochemie Ltd. The product is indicated for the treatment of acute and chronic schizophrenic disorders. A comprehensive description of the indications and posology is given in the SmPC. Amisulpride is a substituted benzamide derivative which belongs to the class of atypical antipsychotic drugs. Its pharmacological activity relies predominantly on the antagonism at dopamine D3 and D2 receptors in the limbic system as compared to the striatum, which might account for its reduced propensity to induce extrapyramidal side effects. In contrast to other antipsychotics, including other atypical agents, Amisulpride is strongly selective for dopamine D3 and D2 receptors, but has no affinity for D1, D4 and D5 receptors and barely interacts with serotonergic, α-adrenergic, cholinergic or histaminergic receptors. This decentralised procedure concerns a generic application claiming essential similarity with the reference product Solian 50 mg, 100 mg, 200 mg and 400 mg tablets, which has been registered in France by Sanofi-aventis since In Denmark, the reference product is Solian 50 mg, 100 mg, 200 mg tablets and 400 mg film-coated tablets, registered since 2001 by Sanofi-aventis Denmark A/S (50 mg and 200 mg) and 2004 (100 mg and 400 mg), respectively. The 400 mg tablets were withdrawn by the MAH in The marketing authorisation is granted based on article 10.1 and 10.3 of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Each tablet contains 50 mg, 100 mg, 200 mg or 400 mg of amisulpride. The 50 mg tablets are white, round, flat, tablets, with diameter 7 mm The 100 mg tablets are white, round, flat, tablets, with diameter 9.5 mm, embossed MC on one side. The 200 mg tablets are white, round, flat, scored on one side tablets, with diameter 11.5 mm. The 400 mg tablets are white, biconvex, capsule shaped tablets, scored on both sides, with dimensions 19 x 10 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. The tablets are packed in PVC/PE/PVDC-Alu blisters or PVC/PVDC-Alu blisters packs containing 30, 60 and 90 tablets. However, not all pack sizes may be marketed. The tablets contain: Lactose monohydrate; sodium starch glycolate type A; hypromellose E5; cellulose microcrystalline PH-101 and magnesium stearate. The RMS has been assured that acceptable standards of GMP (see Directive 2003/94/EC) are in place for this product type at all sites responsible for the manufacturing of the active substance as well as for the manufacturing and assembly of this product prior to granting its national authorisation. 2/7

3 II.2 Drug Substance The active substance, amisulpride, is described in the European Pharmacopoeia. It is a white or almost white, crystalline powder. It is practically insoluble in water, freely soluble in methylene chloride and sparingly soluble in anhydrous ethanol. It is not optically active. The active substance is sourced from two suppliers. Both manufacturers of the active substance has obtained a Certificate of Suitability (CEP), a copy of which is presented in the documentation. The drug product manufacturer controls the active substance according to Ph.Eur. with an additional test for particle size. The re-test period is according to the CEPs. II.3 Medicinal Product The finished product is standard tablets manufactured by conventional technique. The development of the product has been described, the choice of excipients is justified and their functions explained. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed on eight batches. The batch analysis results show that the finished product meets the specifications proposed. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for the drug product are adequately drawn up. In addition, photostability testing in accordance with ICH Q1B has been conducted. Based on 18 months of long-term stability data and accelerated studies the proposed shelf-life of 24 months with no special requirements to the storage conditions has been accepted. III. NON-CLINICAL ASPECTS III.1 Introduction Pharmacodynamic, pharmacokinetic and toxicological properties of amisulpride are well known. As amisulpride is a widely used, well-known active substance, the MAH has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. The non-clinical overview report refers 16 publications up to year The non-clinical overview on the pre-clinical pharmacology, pharmacokinetics and toxicology is adequate. III.2 Ecotoxicity/environmental risk assessment (ERA) Since amisulpride 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. 3/7

4 IV. CLINICAL ASPECTS IV.1 Introduction Amisulpride is a well-known active substance with established efficacy and tolerability. As amisulpride is a widely used, well-known active substance, the MAH has not provided additional studies (apart from a supportive bioequivalence study referenced below) and further studies are not required. Overview based on literature review is, thus, appropriate. The clinical report refers 19 publications up to year The clinical overview on the clinical pharmacology, efficacy and safety is adequate. IV.2 Pharmacokinetics To support the application, the MAH submitted as report one bioequivalence with Solian 400 mg filmcoated tablets, from the Cyprian market as the reference product and Aktiprol 400 mg tablets as the test product. Biowaiver A bioequivalence study was performed to investigate in vivo similarity between the test product 400 mg and the reference product 400 mg. The MAH requested a biowaiver for the lower strengths based on in vitro similarity between the test product biobatch 400 mg and the three lower strengths (50 mg, 100 mg and 200 mg). Conditions for biowaiver of the lower strengths are fulfilled in accordance with the BE guideline. Bioequivalence study The study was an open-label, randomized, two-treatment, two-sequence, two-period, two-way crossover, single-dose bioavailability study conducted under fasting with a wash out period of 7 days between the two administrations. 400 mg was administered in each period. A total of 62 subjects were screened and of those 48 subject who met the inclusion criteria where enrolled in the study. 45 subjects completed the study and 44 included in the pharmacokinetic evaluation. The primary variables for the evaluation of bioequivalence were AUC 0-last (60 hours) and C max. ANOVA was performed on the ln-transformed C max, AUC 0-t and AUC 0-. The 90% confidence intervals for C max and AUC 0-last were to be within the 80 to 125% bioequivalence range in order for bioequivalence to be concluded. 4/7

5 Results Table 1. Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t max median, range) Bioequivalence between the test and the reference product was demonstrated since 90% CI for C max and AUC 0-last were within the criteria ( %). Pharmacokinetic conclusion Based on the submitted bioequivalence study, Aktiprol 400 mg tablets was considered bioequivalent with Solian 400 mg film-coated tablets, Sanofi-aventis. The justification for waiving studies on the lower strengths (50 mg, 100 mg and 200 mg, tablets), based on the study with the 400 mg strengths, was accepted and the results for the study on the 400 mg strength can be extrapolated to the lower strengths. The RMS has been assured that the bioequivalence study has been conducted in accordance with acceptable standards of Good Clinical Practice (GCP, see Directive 2005/28/EC) and Good Laboratory Practice (GLP, see Directives 2004/9/EC and 2004/10/EC). IV.3 Risk Management Plan The MAH has submitted a risk management plan, in accordance with 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 Aktiprol. The following summary list of safety concerns with no additional pharmacovigilance measures or risk minimisation measures has been agreed: 5/7

6 Table 2. Summary table of safety concerns as approved in RMP V. USER CONSULTATION The package leaflet has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the PIL was English. The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. The test consisted of a pilot test followed by two rounds with 10 participants each. The questions covered the following areas sufficiently: traceability, comprehensibility and applicability. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Aktiprol 50 mg, 100 mg, 200 mg and 400 mg tablets has a proven chemical-pharmaceutical quality and is a generic form of Solian. Solian is a well-known medicinal product with an established favourable efficacy and safety profile. Bioequivalence has been shown to be in compliance with the requirements of European guidance documents. 6/7

7 The MAH has presented a risk management plan summarising the safety concerns. There are no additional pharmacovigilance or risk minimisation measures. Agreement between Member States was reached during a written procedure. There was no discussion in the CMD(h). The Concerned Member States, on the basis of the data submitted, considered that essential similarity has been demonstrated for Aktiprol with the reference product, and therefore granted a marketing authorisation. The decentralised procedure was finalised on 20 April Aktiprol was authorised in Denmark on 27 May PSURs should be submitted 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. The date for the first renewal will be: 20 April There were no post-approval commitments made during the procedure. 7/7

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