Public Assessment Report. Scientific discussion. Zolmitriptan Arrow. 2.5 mg and 5 mg film-coated tablets 2.5 mg and 5 mg orodispersible tablets

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1 Public Assessment Report Scientific discussion Zolmitriptan Arrow 2.5 mg and 5 mg film-coated tablets 2.5 mg and 5 mg orodispersible tablets Zolmitriptan DK/H/1957/ /DC Date: 23 September 2013 This module reflects the scientific discussion for the approval of Zolmitriptan Arrow. The procedure was finalised on 28 July 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 Zolmitriptan Arrow 2.5 mg and 5 mg film-coated tablets and 2.5 mg and 5 mg orodispersible tablets, from Arrow Generics Limited. The product is indicated for: Acute treatment of migraine headache with or without aura. 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 reference product Zomig and Zomig Rapimelt which have been registered in Europe by AstraZeneca since The marketing authorisation has been granted pursuant to Article 10(1) of Directive 2001/83/EC. Zolmitriptan has been demonstrated to be a selective agonist for 5HT1B/ID receptors mediating vascular contraction. Zolmitriptan has high affinity for human recombinant 5HTIB and 5HTID receptors, and modest affinity for 5HTIA receptors. Zolmitriptan has no significant affinity or pharmacological activity at other 5HT receptor subtypes (5HT2, 5HT3, 5HT4) or adrenergic, histaminic, muscarinic or dopaminergic receptors. The selective serotonin 5-HT1B and 5-HT1D receptor agonist zolmitriptan is thought to interfere with two aspects implicated in the pathophysiology of migraine attacks, i.e. the abnormal dilation of cranial carotid blood vessels and the release of pro-inflammatory neuropeptides from trigeminal neuronal terminals. II. II.1 QUALITY ASPECTS Introduction The chemical-pharmaceutical documentation and Quality Overall Summary in relation to Zolmitriptan Arrow 2.5 mg and 5 mg film-coated tablets and 2.5 mg and 5 mg orodispersible tablets are of sufficient quality in view of the present European regulatory requirements. Each film-coated tablet contains 2.5 mg and 5 mg of zolmitriptan, respectively. Each orodispersible tablet contains 2.5 mg and 5 mg of zolmitriptan, respectively. The 2.5 mg film-coated tablets are yellow, round, biconvex film-coated tablets with a diameter of approximately 7.5 mm. The 5 mg film-coated tablets are pink, round, biconvex film-coated tablets with a diameter of approximately 9.0 mm. The 2.5 mg orodispersible tablets are white, round, flat tablets with a diameter of approximately 6.5 mm. The 5 mg orodispersible tablets are white, round, flat tablets with a diameter of approximately 8.0 mm. The film-coated tablets are provided in blister packs (OPA/Aluminium/PVC/Aluminium blisters) in pack sizes of 2, 3, 6, 12 and 18 tablets. However, not all pack sizes may be marketed. The orodispersible tablets are provided in peelable aluminium laminate blister packs in pack sizes of 2, 3, 6 and 12 tablets. However, not all pack sizes may be marketed. The excipients in the film-coated tablets are: Tablet core 2/9

3 Lactose anhydrous Silicified Microcrystalline Cellulose, Sodium Starch Glycolate, Type A Magnesium Stearate Film coating (for 2.5 mg) Opadry II 85F Yellow consisting of: Polyvinyl Alcohol, Titanium dioxide, Macrogol, Talc, Iron oxide yellow Film coating (for 5 mg) Opadry II 85F Pink consisting of: Polyvinyl Alcohol Titanium dioxide, Macrogol, Talc, Iron oxide red, Iron oxide yellow The orodispersible tablet contains: Dextrates, Hydrated; Silicified Microcrystalline Cellulose; Croscarmellose sodium; Sucralose; Orange Flavour (consisting of maize maltodextrin, flavouring preparations, flavouring substances, E 307 Alpha-tocopherol, natural flavouring substances), and Magnesium Stearate. The RMS has been assured that acceptable standards of GMP (see Directive 2003/94/EC) are in place for these product types 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. II.2 Drug Substance The active substance zolmitriptan is not described in the European Pharmacopoeia. INN: Zolmitriptan Chemical name(s): (4S)-4-[{3-[2-Dimethyl amino)ethyl]-1h-indol-5-yl]methyl]-2-oxazolidinone N, N-dimethyl-2- [5-(2-oxo-1,3-oxazolidin-4-yl-methyl)-1H-indol-3-yl]ethyl amine Molecular formula: C16H21N3O2 Molecular mass: Molecular structure: Zolmitriptan is an off-white to cream coloured crystalline powder. It is freely soluble in methanol. Aqueous solubility of zolmitriptan is ph dependent. The documentation on the active substance S-zolmitriptan is presented as a European Drug Master File/Active Substance Master File (DMF). 3/9

4 The chemical-pharmaceutical documentation and Quality Overall Summary of the drug substance in relation to Zolmitriptan Arrow 2.5 mg and 5 mg film-coated tablets and 2.5 mg and 5 mg orodispersible tablets are in general of sufficient quality in view of the present European regulatory requirements. Stability studies have been performed with the drug substance. No significant changes in any parameters were observed. The proposed retest period is justified. The control tests and specifications for the drug substance product are adequately drawn up. The potential genotoxic impurities originating from intermediates are adequately controlled. II.3 Medicinal Product Film-coated tablets 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 3 pilot batches. The batch analysis results show that the finished products meet the specifications proposed. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. Impurities RRT 0.34 and RRT 0.54 are degradation products controlled as any unspecified impurity. Unspecified impurities have been identified and included in the API specification as specified impurities: Impurity D and N-oxide impurity with a limit of NMT 0.5%. The following shelf-life/storage condition is recommended for approval: 24 months/this medicinal product does not require any special storage conditions. The proposed bulk holding time of 12 months long term-storage is acceptable. Orodipsersible tablets 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. Resistance to crushing is included as an informative parameter. Validations of the analytical methods have been presented. Batch analysis has been performed on 3 pilot batches. The batch analysis results show that the finished products meet the specifications proposed. The conditions used in the stability studies are according to the ICH stability guideline. The control tests and specifications for drug product are adequately drawn up. Impurities RRT 0.34 and RRT 0.49 are degradation products controlled as any unspecified impurity. Unspecified impurities have been identified and included in the API specification as specified impurities: Impurity D and N-oxide impurity with a limit of NMT 0.5%. The following shelf-life/storage condition is recommended for approval: 24 months/do not store above 30 C. The proposed bulk holding time of 12 months is acceptable. The same storage condition has been implemented as approved for the finished products: Do not store above 30 C. III. NON-CLINICAL ASPECTS 4/9

5 III.1 Introduction Pharmacodynamic, pharmacokinetic and toxicological properties of the active substance are well known. This product is a generic formulation of Zomig and Zomig Rapimelt, which are available on the European market. No new preclinical data have been submitted, and therefore the application has not undergone preclinical assessment. This is acceptable for this type of application. Environmental risk assessment The product is intended as a substitute for other identical products on the market. The approval of this product will not result in an increase in the total quantity of zolmitriptan released into the environment. It does not contain any component, which results in an additional hazard to the environment during storage, distribution, use and disposal. IV. CLINICAL ASPECTS Zolmitriptan is a well-known active substance with established efficacy and tolerability. The pharmacokinetics of zolmitriptan are well-established. Based on the available published literature including the brand leader s product information, a summary of the pharmacokinetic is provided below. In addition, the applicant has provided two bioequivalence studies, one study for 5 mg filmcoated tablets and one study for 5 mg orodispersible tablets. Pharmacokinetics Orally administered zolmitriptan is rapidly absorbed in healthy volunteers (75% of the maximum plasma concentration (C max ) is achieved within 1 hour). However, there is limited evidence to indicate that, like all serotonin 5-HT1B/1D receptor agonists ( triptans ), the absorption of zolmitriptan 10 mg is slowed during migraine associated with severe headache, nausea and photophobia. Area under the plasma concentration versus time curve (AUC) and C max values showed approximate dose proportionality over the range zolmitriptan 2.5 to 50 mg. However, there is considerable interindividual variation in plasma zolmitriptan concentrations. Food has no significant effect on the oral absorption of a 5 mg dose of zolmitriptan. The mean absolute bioavailability of oral zolmitriptan 2.5 mg in healthy volunteers is 39%. Binding to plasma proteins is not extensive (approx. 25%) and the mean volume of distribution following oral 2.5 and 5 mg doses of zolmitriptan is 8.3 L/kg. Zolmitriptan is cleared principally by hepatic metabolism followed by urinary excretion of its metabolites. It has 3 major metabolites: an active N-desmethyl (183C91), an N-oxide and an indole acetic acid metabolite. Zolmitriptan is metabolised by the cytochrome P450 isoenzyme (CYP) 1A2 and by monoamine oxidase A and metabolism of the N-desmethyl metabolite occurs via monoamine oxidase A. Zolmitriptan is rapidly eliminated from the body. The mean plasma elimination half-life (t ½ ) is about 2.6 hours after a single 2.5 or 5mg dose. Oral bioavailability and mean C max and AUC values are generally higher in women than in men, and the difference is significant with doses >5mg, but t½ is similar. Although renal clearance of zolmitriptan and its active metabolite are reduced in the elderly, dosage adjustments are not necessary in this population. Patients with hepatic impairment have increased systemic exposure to zolmitriptan. Patients with moderate or severe hepatic impairment also have a prolonged t ½ and reduced apparent total clearance of zolmitriptan than healthy volunteers. Therefore, zolmitriptan dosage should be reduced in patients with moderate or severe hepatic impairment. Changes in the pharmacokinetics of zolmitriptan and its metabolites in patients with moderate to severe renal impairment (creatinine clearance <40 ml/min) are unlikely to be clinically important. Pharmacodynamics Zolmitriptan has high affinity for serotonin 5-HT1B/1D receptors with modest selectivity for the 5- HT1D subtype over the 5-HT1B subtype. The drug has moderate affinity for 5-HT1A and 5-HT1F receptors, but negligible or no affinity for a wide range of other receptors. Zolmitriptan has 1 active major metabolite that is expected to contribute to the therapeutic efficacy of the drug. The 2 remaining 5/9

6 major metabolites are not active. Drugs used in the acute treatment of migraine are well known to cause constriction of cranial blood vessels and a redistribution of blood flow in the cranial circulation. Indeed, zolmitriptan induces constriction of various isolated vascular preparations known to contain 5- HT1B/1D receptors; maximal contraction of isolated human coronary arteries with zolmitriptan is similar to that with naratriptan, rizatriptan and sumatriptan. Reductions in carotid arterial conductance with zolmitriptan are almost exclusively caused by constriction of cranial arteriovenous anastomotic shunts. Importantly, zolmitriptan produces no change in intracranial cerebral blood flow. Various animal models have demonstrated that zolmitriptan has the ability to inhibit trigeminovascular activation both peripherally and centrally, actions which may be relevant to its therapeutic efficacy. Although single doses of zolmitriptan 1 to 50 mg produce increases in blood pressure in healthy volunteers, changes are generally not considered to be clinically significant and individual data often showed high variability. Zolmitriptan 20 mg does not significantly alter cardiac output or heart rate in healthy volunteers. Although data from volunteers and patients with migraine shows that zolmitriptan acts centrally (on serotonergic pathways), available data indicate that the drug does not induce cognitive or psychomotor impairment in healthy volunteers. Bioequivalence studies To support the application, the applicant has submitted as report two bioequivalence studies, one study for 5 mg film-coated tablets and one study for 5 mg orodispersible tablets. In both studies the test product is compared with brandleader AscoTop 5 mg film-coated tablets and orodispersible tablets, respectively, AstraZeneca, from the German market, as single dose and under fasting conditions and without water for the orodispersible tablet. The design of the studies were open-labelled, randomized, balanced, two-treatment, two-sequence, two-period, two-way crossover, single-dose bioavailability study conducted under fasting conditions in normal, adult, healthy, male and female subjects with a wash out period of at least 7 days between the administration of a single dose 5 mg zolmitriptan in each period. In the study with the orodispersible tablets the study drugs were administrated without water after wetting the mouth with 20 ml of water. The pharmacokinetic variables calculated were AUC 0-t, AUC 0-, C max, t max, K el and t ½. Data of 29 subjects were analysed in both studies. The 90% CI for both AUC 0-t and C max (primary variables) for zolmitriptan were within the acceptance criteria of % to demonstrate bioequivalence. The product proposed for marketing was tolerated equally well as reference product. Biowaivers for the 2.5 mg film-coated tablets and 2.5 mg orodispersible tablets are considered acceptable. Results Table 1. Pharmacokinetic parameters film-coated tablets 6/9

7 Table 2. Pharmacokinetic parameters orodispersible tablets 7/9

8 Conclusion on bioequivalence studies Based on the submitted bioequivalence studies Zolmitriptan Arrow 5 mg film-coated tablets and 5 mg orodispersible tablets are considered bioequivalent with AscoTop 5 mg film-coated tablets and 5 mg orodispersible tablets from AstraZeneca. 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.1 Risk management plan & Pharmacovigilance system Zolmitriptan was first approved in 1997, and there is now more than 10 years post-authorisation experience with the active substance. The safety profile of zolmitriptan can be considered to be well established and no product specific pharmacovigilance issues were identified pre- or postauthorisation which are not adequately covered by the current SPC. Additional risk minimisation activities have not been identified for the reference medicinal product. The MAH has a pharmacovigilance system at their disposal, which is based on the current European legislation. The Pharmacovigilance system described fulfils the requirements and provides adequate evidence that the applicant has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the identification and notification of any a potential risks occurring either in the Community or in a third country. V. PRODUCT INFORMATION SmPC and Package leaflet As this is a generic product of a reference medicinal product authorised by the Community the SmPC must according to Regulation (EC) no. 726/2004 of the European Parliament and of the Council be in all relevant respect consistent with that of the Brand leader. The content of the SmPC and package leaflet approved during the decentralised procedure is in accordance with that accepted for the reference products Zomig and Zomig rapimelt marketed by AstraZeneca. User consultation The package leaflet for the film-coated tablets 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 package leaflet was English. The test consisted of: a pilot test with 3 participants, followed by two rounds with 10 participants each. The questions covered the following areas sufficiently: traceability, comprehensibility and applicability. 8/9

9 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. A user consultation with target patient groups on the package leaflet for the orodispersible tablets has been performed on the basis of a bridging report making reference to the package leaflet for the filmcoated tablets. The bridging report submitted by the applicant has been found acceptable. VI. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION Zolmitriptan has a well-recognised efficacy and an acceptable level of safety in the indications approved for the proposed tablets, and corresponding products have been widely used in many countries. The application contains an adequate review of published clinical data and the bioequivalence has been shown. The chemical-pharmaceutical documentation and Quality Overall Summary in relation to Zolmitriptan Arrow film-coated tablets 2.5 mg and 5 mg and Zolmitriptan Arrow orodispersible tablets 2.5 mg and 5 mg are of sufficient quality in view of the present European regulatory requirements. Bioequivalence has been shown to be in compliance with the requirements of European guidance documents. The MAH has provided written confirmation that systems and services are in place to ensure compliance with their pharmacovigilance obligations. The SmPC, package leaflet and labelling are in the agreed templates and are in agreement with what has been approved for the reference products Zomig and Zomig rapimelt marketed by AstraZeneca and approved by the Community. 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 Zolmitriptan Arrow with the reference product, and have therefore granted a marketing authorisation. The decentralised procedure was finalised on 28 July Zolmitriptan Arrow was authorised in Denmark on 7 September A European harmonised birth date has been allocated ( ) and subsequently the next data lock point for zolmitriptan is March 2012, after which the PSUR submission cycle is 3 years. The date for the first renewal will be: 28 July The following post-approval commitments have been made during the procedure: Process validation will be performed on the first 3 production scale batches (of each strength) manufactured at proposed manufacturing site. The enclosed stability studies will be continued. The first 3 production batches of each strength will be put on stability and tested according to the stability protocol as presented in section P /9

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