MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS

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1 MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 4 Steps taken for assessment Page 13 Steps taken after authorisation summary Page 14 Summary of Product Characteristics Page 15 Product Information Leaflet Page 15 Labelling Page 15

2 LAY SUMMARY Migraine Relief 342 mg Film-Coated Tablets (ibuprofen lysine 342 mg film-coated tablets) This is a summary of the public assessment report (PAR) for Migraine Relief 342 mg Film-coated Tablets (PL 20154/0030). It explains how Migraine Relief 342 mg Film-coated Tablets 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 Migraine Relief 342 mg Film-coated Tablets. For practical information about using Migraine Relief 342 mg Film-coated Tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Migraine Relief 342 mg Film-coated Tablets and what are they used for? Migraine Relief 342 mg Film-coated Tablets is a generic medicine. This means that Migraine Relief 342 mg Film-coated Tablets are similar to a reference medicine already authorised in the European Union (EU) called Crookes Analgesic 342 mg Film-coated Tablets (currently marketed as Nurofen Express/Nurofen Migraine Pain/Nurofen Tension Headache 342 mg caplets). Migraine Relief 342 mg Film-coated Tablets are used for the relief of headaches and migraine pain. How are Migraine Relief 342 mg Film-coated Tablets used? The medicine can be obtained without a prescription How do Migraine Relief 342 mg Film-coated Tablets work? The medicine contains the active substance ibuprofen lysine. Ibuprofen lysine belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body s response to pain, swelling and high temperature. How have Migraine Relief 342 mg Film-coated Tablets been studied? Because Migraine Relief 342 mg Film-coated Tablets is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Nurofen Migraine Pain, 342 mg caplets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. What are the benefits and risks of Migraine Relief 342 mg Film-coated Tablets? Because Migraine Relief 342 mg Film-coated Tablets is a generic medicine that is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine. Why are Migraine Relief 342 mg Film-coated Tablets approved? It was concluded that, in accordance with EU requirements, Migraine Relief 342 mg Film-coated Tablets have been shown to have comparable quality and to be bioequivalent to Nurofen Migraine Pain, 342 mg caplets. Therefore, the view was that, as for Nurofen Migraine Pain, 342 mg caplets, the benefit outweighs the identified risk. 2

3 What measures are being taken to ensure the safe and effective use of Migraine Relief 342 mg Film-coated Tablets? Safety information has been included in the summary of product characteristics and the package leaflet for Migraine Relief 342 mg Film-coated Tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Other information about Migraine Relief 342 mg Film-coated Tablets The marketing authorisation for Migraine Relief 342 mg Film-coated Tablets was granted on 04 September The full PAR for Migraine Relief 342 mg Film-coated Tablets follows this summary. For more information about treatment with Migraine Relief 342 mg Film-coated Tablets, read the package leaflet or contact your doctor or pharmacist. This summary was last updated in

4 MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 SCIENTIFIC DISCUSSION TABLE OF CONTENTS Introduction Page 5 Pharmaceutical assessment Page 6 Non-clinical assessment Page 9 Clinical assessment (including statistical assessment) Page 10 Overall conclusions and benefit/risk assessment Page 12 4

5 INTRODUCTION The MHRA granted Ivowen Limited a Marketing Authorisation (licence) for the medicinal product Migraine Relief 342 mg Film-coated Tablets (PL 20154/0030) on 04 September This is a General Sales List medicine (GSL) indicated for the relief of headache and migraine pain. This was submitted as an abridged application according to Article 10(1) of Directive 2001/83/EC, as amended, claiming to be a generic medicinal product of the originator product Crookes Analgesic 342 mg Film-coated Tablets (PL 00327/0125; Crookes Healthcare Limited), which was initially granted a licence in the UK on 27 July The current marketing authorisation holder for the reference product is Reckitt Benckiser Healthcare (UK) Limited (PL 00063/0380), following a change of ownership that was concluded on 29 April The reference product is currently marketed in the UK as Nurofen Express/Nurofen Migraine Pain/Nurofen Tension Headache 342 mg caplets. This product contains the active ingredient ibuprofen lysine. Ibuprofen lysine is the lysine salt of ibuprofen, a propionic acid derivative, having analgesic, anti-inflammatory and antipyretic activity. The therapeutic effects of ibuprofen lysine as a non steroidal anti-inflammatory drug are thought to result from inhibitory activity on prostaglandin synthesis. Following oral administration, ibuprofen lysine dissociates to ibuprofen acid and lysine. Lysine has no recognised pharmacological activity. The pharmacological properties of ibuprofen lysine, therefore, are the same as those of ibuprofen acid. No new non-clinical studies were conducted, which is acceptable given that the application is a generic application based on an originator product that has been licensed for over 10 years. With the exception of the bioequivalence studies, no new clinical studies were conducted, which is acceptable given that the application is a generic application based on an originator product that has been licensed for over 10 years. Two bioequivalence studies were performed, the first of which compared the pharmacokinetics of a higher strength of the test product, ibuprofen lysine 684 mg film-coated tablets, with those of Nurofen Flash 400 mg tablets (the reference product; Reckitt Benckiser Healthcare Ltd, France). As this study did not meet the criteria for a biowaiver specified in the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**), the results of this study could not be extrapolated to the lower strength product and a further study was requested. The second study compared the pharmacokinetics of Migraine Relief 342 mg Film-coated Tablets with those of Nurofen Migraine Pain 342 mg caplets (Reckitt Benckiser Healthcare (UK) Limited). The bioequivalence studies were carried out in accordance with Good Clinical Practice (GCP) The MHRA has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for this product type at all sites responsible for the manufacture and assembly of this product. 5

6 PHARMACEUTICAL ASSESSMENT DRUG SUBSTANCE Ibuprofen Lysine INN: Ibuprofen Lysine salt Chemical name(s): (i) Benzeneacetic acid, α- methyl-4-(2-methylpropyl), (±)-,(±)-lysine salt; (ii) (±)-p-isobutylhydratropic acid, (±)- Lysine salt; (iii) (±)-2-(p-Isobutylphenyl) propionic acid, (±) mixture, (±)-lysine salt; (iv) (RS)-2-(4- Isobutylphenyl) propionic acid, (RS) lysine salt. Structure: Molecular formula: C 13 H 18 O 2.C 6 H 14 N 2 O 2 Molecular weight: Physical form: White to off-white crystalline powder, which is freely soluble in water, soluble in methanol and ethanol, and sparingly soluble in isopropanol. An Active Substance Master File (ASMF) has been provided by the active substance manufacturer, covering the manufacture and control of the active substance ibuprofen lysine. Synthesis of the drug substance from the designated starting materials has been adequately described and appropriate in-process controls and intermediate specifications are applied. Satisfactory specification tests are in place for all starting materials and reagents and these are supported by relevant certificates of analysis. Appropriate proof-of-structure data have been supplied for the active substance. All potential known impurities have been identified and characterised. An appropriate specification is provided for the active substance. Analytical methods have been appropriately validated and are satisfactory for ensuring compliance with the relevant specifications. Satisfactory Certificates of Analysis have been provided for all working standards. Batch analysis data are provided and comply with the proposed specification. Suitable specifications have been provided for all packaging used. The primary packaging has been shown to comply with current guidelines concerning contact with food. Appropriate stability data have been generated supporting a suitable retest period when stored in the proposed packaging. DRUG PRODUCT Other ingredients consist of the pharmaceutical excipients, as follows: Tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, povidone, magnesium stearate, talc (E553b) Tablet coating: hydrolysed polyvinyl alcohol, titanium dioxide (E171), macrogol and talc (E553b) Printing Ink: shellac, iron oxide black (E172) and ammonium hydroxide (E527) 6

7 The microcrystalline cellulose complies with its United States Pharmacopeia - National Formulary monograph. The white coating agent and black printing ink comply with suitable in-house standards. All other excipients comply with their respective European Pharmacopoeia monographs. None of the excipients are sourced from animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of this product. Pharmaceutical development The objective of the pharmaceutical development programme was to produce safe, tolerable capsules that could be considered generic medicinal products of the originator product Crookes Analgesic 342 mg Film-coated Tablets (Crookes Healthcare Limited), which is currently marketed as Nurofen Express/Nurofen Migraine Pain/Nurofen Tension Headache 342 mg caplets. The applicant has provided a suitable product development rationale and data. Comparative in vitro dissolution and impurity profiles have been provided for the applicant s product versus the reference product. Manufacture Satisfactory batch formulae have been provided for the manufacture of the product, along with an appropriate account of the manufacturing process. Suitable in-process controls are in place to ensure the quality of the finished product. Process validation has been carried out on three production-scale batches of finished product. The results are satisfactory. Finished product specification The finished product specification is satisfactory. Test methods have been described and have been adequately validated, as appropriate. Batch data have been provided that comply with the release specification. Certificates of analysis have been provided for any working standards used. Container Closure System The finished product is packaged in blisters that are comprised of the following: white opaque polyvinylchloride laminated with Aclar on one side and hard tempered aluminium foil, coated with vinyl acetate-maleic acid-vinyl chloride copolymer heat-seal lacquer, on the other side or oriented polyamide/aluminium/polyvinylchloride on one side and hard tempered aluminium foil, coated with vinyl acetate-maleic acid-vinyl chloride copolymer heat-seal lacquer, on the other side The blisters are packaged in an outer cardboard carton, in pack sizes of 8, 12 and 16 tablets. Specifications and Certificates of Analysis for all packaging components used have been provided. These are satisfactory. Stability Stability studies were performed, in accordance with current guidelines, on batches of finished product manufactured by the finished product manufacturer and packed in the packaging proposed for marketing. The results from these studies support a shelf-life of 2 years, with no special storage conditions. Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), Labels 7

8 The SmPC, PIL and labels are pharmaceutically acceptable. A package leaflet has been submitted to the MHRA along with results of consultations with target patient groups ("user testing"), in accordance with Article 59 of Council Directive 2001/83/EC, as amended. The results indicate that the package leaflet is well-structured and organised, easy to understand and written in a comprehensive manner. The test shows that the patients/users are able to act upon the information that the package leaflet contains. MAA forms The MAA form is pharmaceutically satisfactory. Expert report The pharmaceutical expert report has been written by an appropriately qualified person and is a suitable summary of the pharmaceutical dossier. Conclusion It is recommended that a Marketing Authorisation is granted for this application. 8

9 NON-CLINICAL ASSESSMENT As the pharmacodynamic, pharmacokinetic and toxicological properties of ibuprofen lysine are well-known, no further non-clinical studies are required and none have been provided. The applicant s non-clinical expert report has been written by an appropriately qualified person and is satisfactory, providing an appropriate review of the product s pharmacology and toxicology. A suitable justification has been provided for non-submission of an environmental risk assessment. As these products are intended for generic substitution with products currently marketed, the environmental burden is not expected to increase. Thus, the justification for non-submission of an Environmental Risk Assessment is accepted. There are no objections to the approval of this product from a non-clinical viewpoint. 9

10 CLINICAL ASSESSMENT CLINICAL PHARMACOLOGY In support of this application, the Marketing Authorisation Holder has submitted the following bioequivalence studies: Study 1 The following study was conducted using a higher strength of the test product. A biowaiver was requested to extrapolate the results of this study to the 342 mg strength. A biowaiver was requested based on the fact that both strengths are manufactured by the same finished product manufacturer at the same manufacturing site, using the same process; the qualitative composition of both strengths is the same; and both strengths are quantitatively proportional. An open-label, balanced, randomised, single-dose, two-treatment, two-sequence, two-period crossover bioequivalence study of ibuprofen lysine tablets 684 mg film-coated tablets (equivalent to ibuprofen 400 mg) and Nurofen Flash 400 mg tablets (the reference product; Reckitt Benckiser Healthcare Ltd, France) in healthy, adult human subjects under fasting conditions. Volunteers were given each treatment under fasting conditions. Blood samples were collected for the measurement of pharmacokinetic parameters pre-dose and up to 12 hours post dose. Each regimen was separated by a 7-day washout period. The main pharmacokinetic results for plasma levels of ibuprofen are presented in the table below: Parameter R-Ibuprofen Cmax 93.19% (88.31% %) AUC0-t % (95.09% %) AUC % (94.72% %) Parameter S-Ibuprofen Cmax 94.65% (90.78% %) AUC0-t % (101.38% %) AUC % (101.50% %) Compared with the reference product, the 90 % confidence intervals for the test product are within % for C max and AUC. Whilst the results of this study indicate bioequivalence between the test and reference product, the results could not be extrapolated to the 342 mg strength of the product. A biowaiver could not be justified according to the Guideline on the Investigation of Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1/Corr**) as similarity of in vitro dissolution between the two strengths of product across the physiological ph range was not demonstrated. A further bioequivalence study was, therefore, submitted. Study 2 An open-label, balanced, randomised, single-dose, two-treatment, two-sequence, two-period crossover study to compare the pharmacokinetics of Migraine Relief 342 mg Film-coated Tablets (the test product) with those of Nurofen Migraine Pain 342 mg caplets (the reference product; Reckitt Benckiser Healthcare (UK) Limited), in healthy, adult, human subjects under fasting conditions. Volunteers were given each treatment under fasting conditions. Blood samples were collected for the measurement of pharmacokinetic parameters pre-dose and up to 12 hours post dose. Each regimen was separated by a 7-day washout period. 10

11 The main pharmacokinetic results for plasma levels of ibuprofen are presented in the tables below: Compared with the reference product, the 90 % confidence intervals for the test product are within % for C max and AUC. Migraine Relief 342 mg Film-coated Tablets are therefore considered bioequivalent with Nurofen Migraine Pain 342 mg caplets. EFFICACY No new data on efficacy have been submitted and none are required for this type of application SAFETY With the exception of the data submitted for the bioequivalence study, no new safety data were submitted and none were required. No new or unexpected safety issues were raised by the bioequivalence data. EXPERT REPORT The clinical expert report has been written by an appropriately qualified physician and is a suitable summary of the clinical aspects of the dossier. SUMMARY OF PRODUCT CHARACTERISTICS (SmPC) This is consistent with the SmPC for the reference product and is satisfactory. PATIENT INFORMATION LEAFLET (PIL) This is consistent with that for the reference product and is satisfactory. LABELLING This is satisfactory APPLICATION FORM (MAA) This is satisfactory. MEDICAL CONCLUSION The grant of a marketing authorisation is recommended for this application. 11

12 OVERALL CONCLUSION AND BENEFIT/RISK ASSESSMENT QUALITY The important quality characteristics of Migraine Relief 342 mg Film-coated Tablets are well-defined and controlled. The specifications and batch analytical results indicate consistency from batch to batch. There are no outstanding quality issues that would have a negative impact on the benefit/risk balance. NON-CLINICAL No new non-clinical data were submitted and none are required for an application of this type. CLINICAL Bioequivalence has been demonstrated between the applicant s Migraine Relief 342 mg Film-coated Tablets and the reference product Nurofen Migraine Pain 342 mg caplets (Reckitt Benckiser Healthcare (UK) Limited). No new or unexpected safety concerns arose from this application. The SmPC, PIL and labelling are satisfactory and consistent with that for the reference product. BENEFIT/RISK ASSESSMENT The quality of the product is acceptable, and no new non-clinical or clinical safety concerns have been identified. Bioequivalence has been demonstrated between the applicant s product and the reference product. Extensive clinical experience with ibuprofen lysine is considered to have demonstrated the therapeutic value of the compound. The benefit-risk assessment is, therefore, considered to be positive. 12

13 MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 STEPS TAKEN FOR ASSESMENT 1 The MHRA received the marketing authorisation application on 22 December Following standard checks and communication with the applicant the MHRA considered the application valid on 17 April Following assessment of the applications the MHRA requested further information on 26 July 2012 and 17 May The applicant responded to the MHRA s requests, providing further information on 08 February 2013, 22 April 2013 and 22 July The application was determined on 04 September

14 MIGRAINE RELIEF 342 MG FILM-COATED TABLETS PL 20154/0030 STEPS TAKEN AFTER AUTHORISATION - SUMMARY Date submitted Application type Scope Outcome 14

15 Summary of Product Characteristics and Patient Information Leaflet The current approved versions of the SmPC and PIL are available on the MHRA website. Labelling Carton: Pack size 8 film-coated tablets: Braille: 15

16 Pack size 12 film-coated tablets: 16

17 Pack size 16 film-coated tablets Blister: 17

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