Public Assessment Report. Scientific discussion. Rizatriptan Apotex disper 5 mg and 10 mg, orodispersible tablets. (rizatriptan benzoate)

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1 Public Assessment Report Scientific discussion Rizatriptan Apotex disper 5 mg and 10 mg, orodispersible tablets (rizatriptan benzoate) NL/H/3152/ /DC Date: 4 July 2016 This module reflects the scientific discussion for the approval of Rizatriptan Apotex disper 5 mg and 10 mg orodispersible tablets. The procedure was finalised at 29 April For information on changes after this date please refer to the steps taken after finalisation at the end of this PAR.

2 List of abbreviations C ASMF CEP CHMP CMD(h) CMS EDMF EDQM EEA ERA ICH MAH Ph.Eur. PL RH RMP SmPC TSE Active Substance Master File Certificate of Suitability to the monographs of the European Pharmacopoeia Committee for Medicinal Products for Human Use Coordination group for Mutual recognition and Decentralised procedure for human medicinal products Concerned Member State European Drug Master File European Directorate for the Quality of Medicines European Economic Area Environmental Risk Assessment International Conference of Harmonisation Marketing Authorisation Holder European Pharmacopoeia Package Leaflet Relative Humidity Risk Management Plan Summary of Product Characteristics Transmissible Spongiform Encephalopathy 2/9

3 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Rizatriptan Apotex disper 5 mg and 10 mg orodispersible tablets from Apotex Europe B.V. The product is indicated for acute treatment of the headache phase of migraine attacks with or without aura in adults. A comprehensive description of the indications and posology is given in the SmPC. This decentralised procedure concerns a generic application claiming essential similarity with the innovator products Maxalt Smelt 5 mg and 10 mg orodispersible tablets (NL License RVG ) which have been registered in the Netherlands by Merck, Sharp and Dohme B.V. since 11 February The concerned member states (CMS) involved in this procedure were Spain and Luxembourg. The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. II. QUALITY ASPECTS II.1 Introduction Rizatriptan Apotex disper 5 mg and 10 mg are white to off-white coloured, round shaped tablets with APO engraved on one side and RZ over respectively 5 and 10 on the other side. The formulations contain mg rizatriptan benzoate (equivalent to 5 mg rizatriptan), and mg rizatriptan benzoate (equivalent to 10 mg rizatriptan) respectively. The two strengths are fully dose proportional. The orodispersible tablets are packaged in an aluminium (Alu-Alu) blister. The excipients used are Microcrystalline cellulose PH102, Mannitol (E421), Crospovidone, Sucralose, Peppermint flavour (containing natural peppermint flavouring, maltodextrin and corn starch) and Magnesium stearate. II.2 Drug Substance The active substance is rizatriptan benzoate, an established active substance described in the European Pharmacopoeia (Ph.Eur). Rizatriptan is non-hygroscopic in nature. Its solubility is high in the ph range of , and is considered as a high soluble drug according to the BCS classification. It has been demonstrated that the same polymorphic form is manufactured consistently. Rizatriptan benzoate isomer may be formed. Specification limits are in place for control of the isomer impurity. The Active Substance Master File (ASMF) procedure is used for the active substance. The main objective of the ASMF procedure, commonly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or know-how of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the applicant or marketing authorisation holder (MAH) to take full responsibility for the medicinal product, the quality and quality control of the active substance. Competent Authorities/EMA thus have access to the complete information that is necessary to evaluate the suitability of the use of the active substance in the medicinal product. Manufacturing process The active substance is manufactured from three proposed starting materials. At the first stage an intermediate is synthesized from two of the starting materials. At the second stage the third starting material is added to the synthesis. In the following steps rizatriptan and finally rizatriptan benzoate are yielded. No class 1 organic solvents are used during the manufacturing process. The active substance 3/9

4 has been adequately characterized. The manufacturing process has been adequately described. Sufficient information has been given related to the starting materials: the suppliers are laid down, the synthesis routes of the starting materials are provided, and adequate specifications for the starting materials (including purity) are provided. Quality control of drug substance The drug substance specification is in line with the Ph.Eur. with a number of additional requirements. The specification is considered acceptable. Batch data demonstrating compliance with the drug substance specification have been provided for at least three production batches. Stability of drug substance Stability data on the active substance have been provided for nine batches stored at 25 C/60% RH (three of the batches for 48 months, three batches for 36 months and the remaining three batches for 18 months) and 40 C/75% RH (7 of the batches for 6 months, while for the remaining two batches no accelerated data were provided). No significant changes were observed. Based on additional stability data of the three latest production batches, in which no significant changes were observed up to 24 months at 25 C/60% RH, a retest period of 36 months, with no special storage conditions in the proposed container closure system, has been granted. II.3 Medicinal Product Pharmaceutical development The development of the product has been described, the choice of excipients is justified and their functions explained. During the development studies such as characterization of reference products, in vitro dissolution of originator orodispersible tablets and investigations of process parameters were performed. One in vivo bioequivalence study was submitted to demonstrate bioequivalence between Rizatriptan Apotex 10 mg strength and the reference medicinal product, Maxalt Melt 10 mg. The bioequivalence study test batch was manufactured according to the finalized manufacturing process and composition. The Rizatriptan Apotex disper 5 mg and 10 mg products are fully dose proportional and are manufactured using the same manufacturing process. For the proposed waiving of additional in vivo bioequivalence testing of the 5 mg strength, dissolution was investigated at different buffers (0.1N HCL, ph 4.5 and ph 6.8), and the media intended for drug product release. Similarity of in vitro dissolution was demonstrated between the additional strength (5 mg) and the batch (10 mg) used for bioequivalence testing. Since >85% is dissolved within 15 minutes, the dissolution profiles are concluded to be similar without further mathematical evaluation. The general biowaiver criteria are thereby met and the requested bio-waiver for the 5 mg strength can be granted. The choices of the packaging and manufacturing process are justified. In view of the type of dosage form, satisfactory taste and texture of the tablet has been ensured. Manufacturing process The manufacturing process of rizatriptan orodispersible tablets involves dispensing of the raw materials, de-agglomeration, pre-blending, de-agglomeration of pre-blend, blending, lubrication, compression and packaging. The manufacturing process has been adequately validated according to relevant European guidelines. Process validation data on the product has been presented for two exhibit batches per strength. The product is manufactured using conventional manufacturing techniques. Process validation for full scaled batches will be performed post authorisation. Control of excipients All excipients comply with the Ph. Eur., except the peppermint for which acceptable specifications have been applied. Quality control of drug product The product specification includes tests for appearance, identity, disintegration, average weight, dissolution, uniformity of dosage units, degradation, assay, water content and microbial quality. The product specification is acceptable, based on the batch results and stability results. The release and shelf-life requirements/limits are identical with the exception of water content: a wider shelf life limit for water content is proposed. The analytical methods have been adequately described and validated. 4/9

5 Batch analytical data from the proposed production site have been provided for two batches of the 5 mg and three batches of the 10 mg, demonstrating compliance with the release specification. Stability of drug product Stability data on the product have been provided for two batches per strength stored at 25 C/60% RH (36 months), 30 /65% RH (36 months) and 40 C/75% RH (6 months). The conditions used in the stability studies are according to the ICH stability guideline. The batches were stored in Alu-Alu blisters. Increases in impurities were seen, however all parameters stay well within the proposed specification limits. For the remaining parameters no specific trends were observed. Also no significant changes were seen when the product was exposed to light. Hence no storage condition related to light sensitivity is considered to be necessary. The proposed shelf-life of 24 months is justified, with the following statement related to storage: This medicinal product does not require any special storage conditions. Specific measures concerning the prevention of the transmission of animal spongiform encephalopathies No excipient of human or animal origin is used, nor any novel excipient. None of the excipients used in the proposed product pose a TSE risk. II.4 Discussion on chemical, pharmaceutical and biological aspects Based on the submitted dossier, the member states consider that Rizatriptan Apotex disper 5 mg and 10 mg has a proven chemical-pharmaceutical quality. Sufficient controls have been laid down for the active substance and finished product. No post-approval commitments were made. III. III.1 NON-CLINICAL ASPECTS Ecotoxicity/environmental risk assessment (ERA) Since Rizatriptan Apotex disper 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. III.2 Discussion on the non-clinical aspects This product is a generic formulation of Maxalt Melt lyophylisate, which is available on the European market. A non-clinical overview on the pharmacology, pharmacokinetics and toxicology has not been provided, since rizatriptan is a widely used and well-known active substance. The member states agreed that no further non-clinical studies are required. IV. IV.1 CLINICAL ASPECTS Introduction Rizatriptan is a well-known active substance with established efficacy and tolerability. A clinical overview has been provided, which is based on scientific literature. The overview justifies why there is no need to generate additional clinical data. Therefore, the member states agreed that no further clinical studies are required. For this generic application, the MAH has submitted a bioequivalence study, which is discussed below. 5/9

6 IV.2 Pharmacokinetics C Bioequivalence study One in vivo bioequivalence study was submitted to demonstrate bioequivalence between the test product Rizatriptan Apotex disper 10 mg (Apotex Europe B.V., the Netherlands) and the reference medicinal product Maxalt Melt lyophylisate 10 mg (Merck Sharp & Dohme Limited, UK). The Netherlands is RMS for the MRP procedure under which Maxalt is registered (procedure number NL/H/0144/MR). The choice of the reference product in the bioequivalence study is justified. The formula and preparation of the bioequivalence batch is identical to the formula proposed for marketing. Biowaiver Similarity between the two strengths of the test product (5 mg and 10 mg) has been demonstrated as more than 85% dissolved within 15 minutes at the required 3 different phs. All the criteria required for waiving the bioequivalence study for the 5 mg strength are fulfilled and a biowaiver for the 5 mg can therefore be granted. Design A single-dose, standard randomised, two-way crossover bioequivalence study was carried out under fasted conditions in 42 healthy male subjects, aged years. The subjects had fasted for approximately 10 hours before drug administration. Each subject received a single dose (10 mg) of one of the 2 rizatriptan formulations. First 20 ml water was administered to wet the mouth, and subsequently the product was placed on the tongue until it disintegrated completely and swallowed with the salvia. There were 2 dosing periods, separated by a washout period of 9 days. Blood samples were collected 5-45 minutes prior to dosing and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.3, 2.7, 3, 3.5, 4, 5, 6, 7, 8, 9, 11, 13, 16 and 20 hours post dose after administration of the products. The design of the study is acceptable. The study using the higher strength in the fasting condition to show bioequivalence is in accordance with the guideline. Rizatriptan orodispersible tablets may be taken with and without water. The administration of the study products without water is agreed as this condition best resembles the intended use of the formulation in line with the guideline. The start and the duration of the sampling is sufficient to measure pharmacokinetic parameters considering the t max and half-life ( hours and 2-3 hours, respectively). The wash-out period of 9 days is long enough to prevent carry-over effects (at least 5 times the terminal half-life). Analytical/statistical methods The analytical method has been adequately validated and is considered acceptable for analysis of the plasma samples. The methods used in this study for the pharmacokinetic calculations and statistical evaluation are considered acceptable. Results 41 subjects completed the study and 1 subject was withdrawn as he did not report in period II. All available samples were assayed. Statistical data analysis and the subsequent bioequivalence assessment were conducted on all of the subjects who completed the study. Table 1. Pharmacokinetic parameters (non-transformed values; arithmetic mean ± SD, t max (median, range)) of rizatriptan under fasted conditions Treatment N=41 Test AUC 0-t ng/ml/h AUC 0- ng/ml/h C max ng/ml T max 106 ± ± ± ( ) h t 1/2 h 2.6 ± 0.7 Reference 103 ± ± ± ( ) 2.5 ± 0.7 6/9

7 Ratio ( ) ( ) ( ) (90% CI) AUC 0- area under the plasma concentration-time curve from time zero to infinity AUC 0-t area under the plasma concentration-time curve from time zero to t hours C max maximum plasma concentration T max time for maximum concentration T 1/2 half-life *ln-transformed values C Conclusion on bioequivalence study The 90% confidence intervals calculated for AUC 0-t, AUC 0- and C max are within the bioequivalence acceptance range of Based on the submitted bioequivalence study Rizatriptan Apotex disper 10 mg is considered bioequivalent with Maxalt Melt 10 mg oral lyophylisate. The MEB 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 (RMP), 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 Rizatriptan Apotex disper 5 mg and 10 mg. Summary table of safety concerns as approved in RMP: Important identified risks Myocardial ischaemia/infarction Cerebrovascular events Peripheral vascular events Hypersensitivity Concomitant use with SSRIs Concomitant use with MAO inhibitors Concomitant use with ergot-containing compounds Concomitant use with beta-blockers Medication Overuse Headache (MOH) Important potential risks Use in patients with basilar or hemiplegic migraine Missing information Use during pregnancy Use during lactation Use in patients with severe hepatic insufficiency Use in patients with severe renal insufficiency Use in patients with moderately severe or severe hypertension, or untreated mild hypertension Use by children <18 years of age The member states agreed that routine pharmacovigilance activities and routine risk minimisation measures are sufficient for the risks and areas of missing information. 7/9

8 IV.4 Discussion on the clinical aspects For this authorisation, reference is made to the clinical studies and experience with the innovator product Maxalt Melt 5 mg and 10 mg lyophylisate. No new clinical studies were conducted. The MAH demonstrated through a bioequivalence study that the pharmacokinetic profile of the product is similar to the pharmacokinetic profile of this reference product. Risk management is adequately addressed. This generic medicinal product can be used instead of the reference product. V. USER CONSULTATION The package leaflet (PL) has not been evaluated via a user consultation study. Reference is made to the PL approved for Maxalt Melt lyophylisate (NL/H/0144/MR). The products are therapeutically similar products that belong to the same therapeutic class. The active ingredient of both products is rizatriptan. The indications and instructions for use are identical. The key safety messages are similar. Moreover, the design and layout of the PL of Rizatriptan Apotex disper 5 mg and 10 mg tablets is almost identical to that approved for the PL of (NL/H/0144/MR) and the language used in both PLs is comparable. The bridging report has been found acceptable. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Rizatriptan Apotex disper 5 mg and 10 mg have a proven chemical-pharmaceutical quality and are a generic form of Maxalt 5 mg and 10 mg oral lyophylasite. Maxalt 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. The Board followed the advice of the assessors. There was no discussion in the CMD(h). Agreement between member states was reached during a written procedure. The member states, on the basis of the data submitted, considered that essential similarity has been demonstrated for Rizatriptan Apotex disper 5 mg and 10 mg with the reference product, and have therefore granted a marketing authorization. The decentralised procedure was finalized with a positive outcome on 29 April /9

9 STEPS TAKEN AFTER THE FINALISATION OF THE INITIAL PROCEDURE - SUMMARY Scope Procedure number Type of modification Date of start of the procedure Date of end of the procedure Approval/ non approval Assessment report attached 9/9

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