Public Assessment Report. Scientific discussion. Ropinirol Actavis. Ropinirole hydrochloride DK/H/1212/ /DC

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1 Public Assessment Report Scientific discussion Ropinirol Actavis Ropinirole hydrochloride DK/H/1212/ /DC This module reflects the scientific discussion for the approval of Ropinirole film-coated tablets. The procedure was finalised on 9 July For information on changes after this date please refer to the module Update. 1/7

2 I. INTRODUCTION This assessment report concerns a generic version of ropinirole film-coated tablets 0,25 mg, 0,5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg approved through DCP on 9 July 2008 with Denmark acting as RMS. The applications have been submitted according to Article 10 (1) and Article 10 (3) of Directive 2001/83/EC (generic application and hybrid application). As the 3 mg and 4 mg strength of the reference product are not approved in the Member States, the legal basis for these strengths are applied for according to Article 10 (3) of Directive 2001/83/EC. The reference product for these procedures is Requip 0,25 mg; 1 mg, 2 mg and 5 mg film-coated tablets from GlaxoSmithKline. The approved indication for Requip is treatment of Parkinson s Disease. The Marketing Authorisation was granted in United Kingdom on In addition to Requip Glaxo Smith Kline holds a stand alone Marketing Authorisation for Adartrel 0,25 mg, 0,5 mg, 1 mg and 2 mg, for which the approved indication is symptomatic treatment of moderate to severe Restless Legs Syndrome. Adartrel also contains ropinirole hydrochloride, but is applied for and approved as a full and stand alone application. The first Marketing Authorisation for Adartrel was granted in France on Both products have been approved through the MRP. Since Requip and Adartrel belong to the same global marketing authorisation, no extra data protection should be granted for the Restless Legs indication. The proposed indications for the applied product include both treatment of Parkinson s Disease and Restless Legs Syndrome. With reference to the above discussion the RMS finds it acceptable that both indications are included in the SPC. The active substance is not considered a new active substance. Ropinirole is a non-ergoline dopamine agonist with selective affinity for dopamine D2-like receptors. Indications: Treatment of Parkinson s Disease o As monotherapy in early phase in order to delay levodopa therapy o In combination with levodopa in later stage of the disease when the effect of levodopa is decreased or varies and fluctuations are seen ( end of dose or on-off fluctuations) Symptomatic treatment of moderate to severe idiopatic Restless Legs Syndrome in dosages up to 4 mg daily. Posology: Individual dose titration against efficacy and tolerability is recommended. Ropinirole may be taken with food, to improve gastrointestinal tolerance. Parkinson s Disease: The initial dose is 0.25 mg ropinirole three times per day for one week. Then the dose is gradually increased by 0.25 mg ropinirole three times per day in accordance to table 1 below: Week Unit dose (mg) Total daily dose (mg) After the initial titration weekly increments of 0.5 mg to 1 mg ropinirole three times per day (1.5-3 mg per day) may be given. Therapeutic response are normally seen between 3 and 9 mg/day. Maximum dose is 24 mg/day. 2/7

3 Idipopathic Resless Leg Syndrome Ropinirole should be taken just before bedtime, however the dose can be taken up to 3 hours before retiring. Week 1: The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days. If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1. Week 2 onwards: Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved. Average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day. Maximum dose is 4 mg/day Week * 6* 7* Dose (mg)/once daily * To achieve optimal improvement in some patients. II. QUALITY ASPECTS II.1 Introduction The finished product is presented as film-coated tablets in the strength of 0,25 mg, 0,5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg of ropinirole packed in Blisters: PVC/Aclar/Aluminium blisters; Aluminium/Aluminium blisters and tablet containers: Container made of HDPE with child- resistant screw cap made of HDPE and PP with aluminium foil. The excipients are: Lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, magnesium stearate, polyvinyl alcohol, titanium dioxide E 171, macrogol 3350 and talc. The RMS has been assured that acceptable standards of GMP are in place for these product types at all sites responsible for the manufacture and assembly of this product. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. II.2 Drug Substance The active substance is ropinirole hydrochloride. The EDMF procedure has been followed for the active substance and letters of access have been submitted to the DMA. The chemical-pharmaceutical documentation and Expert Report in relation to ropinirole hydrochloride is of sufficient quality in view of the present European regulatory requirements. The control tests and specifications for drug substance product are adequately drawn up. Stability studies have been performed with the drug substance. No significant changes in any parameters were observed. The proposed retest period of 18 months and 24 months, respectively are justified. II.3 Medicinal Product The development of the drug product has been adequately described, the choice of excipients justified and their function explained. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. Batch analysis has been performed. The batch analysis results show that the finished products meet the specifications proposed. 3/7

4 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. The following proposed shelf-lives and storage conditions are accepted: HDPE container: 12 months /Do not store above 25 C. Al/Al blister: 12 months /Do not store above 25 C. PVC/Aclar/Al: 9 months /Do not store above 25 C. III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of ropinirole are well known. These are generic applications and no new indications have been applied for. The applicant has not submitted new non-clinical information and an overview based on a literature review is therefore appropriate and acceptable to the RMS. IV. CLINICAL ASPECTS IV.1 Introduction The pharmacokinetics of ropinirole are well established. Based on the available published literature including the brand leader s product information, a summary of pharmacokinetics is provided below. In addition, the applicant has provided a bioequivalence study comparing the 0.25 mg film-coated tablet against the brand leader Requip 0.25mg tablets, which is discussed in the bioequivalence section below. IV.2 Pharmacokinetics General description Absorption Ropinirole is rapidly and almost completely absorbed after oral administration with Cmax being reached after approx. 1-2 hours. When taken with a high-fat meal, Tmax is increased by 2½ hours and Cmax decreased by approx. 25%. Although food reduces the rate of absorption, extent is minimally affected and not expected to be of any clinical consequence. Linear kinetics is displayed within the therapeutic dosing range of 1-8mg t.i.d. Steady state is achieved within 2 days of dosing. Distribution Ropinirole is widely distributed in the body and about 40% bound to plasma proteins. Metabolism Ropinirole is extensively metabolised by N-despropylation and hydroxylation in the liver to inactive N-despropyl and hydroxy metabolites. The N-despropyl metabolite is converted further to carbamyl glucuronide, carboxylic acid and N-despropyl hydroxy metabolites. The hydroxy metabolite of ropinirole is glucuronidated. CYP1A2 is involved in ropinirole metabolism and as this enzyme is inducible by smoking, smoking is expected to increase ropinirole clearance. Excretion The elimination t ½ of ropinirole is approx. 6 hours. Less than 10% of the administered dose is excreted unchanged in the urine. N-despropyl ropinirole is the predominant metabolite found in the urine (40%) followed by the carboxylic acid metabolite (10%) and the glucuronide of the hydroxyl metabolite (10%). Bioequivalence 4/7

5 Study design The study was a single centre, open label, randomised, single dose, two-way crossover study conducted under fasting conditions with a wash out period of 7 days between administrations. 0.25mg was administered in each period with 240ml water. Subjects were confined to the clinical research centre from at least 13 hours prior to drug administration until 24 hour post-dose blood draw in each period. Water was permitted ad lib until 1 hour before dosing and again 2 hours after dosing, otherwise ad libitum. Methods of analysis Blood sampling performed predosing and at 0.5, 0.75, 1.0, 1.33, 1.66, 2.0, 2.33, 2.66, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 12.0, 16.0 and 24.0 hours post-dose in each period. Samples were analysed by HPLC with tandem MS detection. Test and reference products Ropinirole 0.25 mg film-coated tablets have been tested against Requip 0.25 mg tablets, Glaxo from the German market. Certificates of analysis for both test and reference products are provided in Module 3 (assay Test: 0.254mg; assay Reference: 0.249mg). The compositions of the test and reference products differ though standard excipients are employed in the test product. Population(s) studied 30 non-smoking, healthy volunteers, were randomised into the study and 29 completed (30 males; years; 50-80kg; all South Asian (Indian). Pharmacokinetic Variables The parameters calculated were AUC 0-t, AUC 0-, C max, t max, t ½, residual area and K el. Primary variables: AUC 0-t, AUC 0- and C max. Secondary parameters: AUC 0-, t max, t ½, residual area, K el and safety. PK variables were determined for ropinirole using WinNonlin version 4.1 Statistical methods Parametric ANOVA was performed on the ln-transformed AUC 0-t, AUC 0- and C max. The ANOVA model included co-variates for sequence, treatment, period and subject within sequence. All effects were tested at the 5% level. Non-transformed T max was evaluated non-parametrically. Bioequivalence criteria 90% geometric intervals of the ratio (A/B) of least square means from the ln-transformed values for AUC 0-t and C max should be within %. Safety parameters were descriptive only. 5/7

6 Results Pharmacokinetic parameters (log-transformed values; arithmetic mean ± SD, t max ± SD, and t½ ±SD) Treatment AUC 0-t AUC 0- C max t max T 1/2 ng.h/ml Test (S.D.) (1.129) Reference (S.D.) (1.410) *Ratio (90% CI) 99% % Intra-subject CV (%) 15.93% ng.h/ml (1.202) (1.475) 99% % 12.91% ng/ml (0.131) 0.52 (0.140) 103% % 9.26% h 2.03 (0.64) 2.25 (0.80) h 4.10 (0.71) 4.32 (0.93) Inter-subject CV (%) 31.79% 31.00% 23.9% 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 *log-transformed values Safety evaluation No serious adverse events were reported. 8 post dose adverse events were recorded, of which 5 were possibly related to treatment. All AEs were reported in period I, were mild to moderate in intensity and resolved completely. 3 AEs were reported after test product and 5 after reference. Pharmacokinetic conclusion Based on the submitted bioequivalence study Ropinirole 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg and 5mg film-coated tablets are considered bioequivalent with Requip tablets with respect to rate and extent of absorption of ropinirole. Tolerability of the test product is acceptable and not significantly different from reference product. V. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION The quality of the product is acceptable and no new preclinical or clinical safety concerns have been identified. The bioequivalence study supports the claim that this generic product and the innovator are interchangeable. The benefit risk is, therefore, considered to be positive. The following commitments have been made during the procedure: Area Description The Applicant commits to continue the on-going stability studies at 30 C/65% RH and at 25 C/60% RH for up to 12 months and 24 months respectively. The Applicant commits to put the first three production scale batches per strength under stability testing, i.e.: 25 C/60% RH for 24 months, 30 C/65% RH for 12 months and 40 C/75% RH for 6 months. The applicant commits that validation reports for three consecutive commercial scale batches per strength of the maximum batch size proposed will be provided before market launch. However, if the first commercial scales batches are smaller than the proposed sizes validation reports for these smaller batch sizes will be provided before market launch. The applicant commits that validation reports for three consecutive commercial scale batches per strength of the maximum batch size proposed will be provided before market launch. However, if the first commercial scales 6/7

7 batches are smaller than the proposed sizes validation reports for these smaller batch sizes will be provided before market launch. The applicant commits to pack the production scale batches in PVC/Aclar/Al blister, Al/Al blister and HDPE tablet container and place them on stability. The applicant commits to inform the Danish Medicines Agency if any problem with the stability during storage of the drug product appears. The proposed gradient method cf. VAL-Ropi-RS-02 should be validated (specificity) concerning the five working standards tested using Val-Ropi-C- 01 ). Likewise LOD and LOQ should be stated as percent using the method cf. VAL-Ropi-RS-02. A report will be provided by 31st July. The Applicant commits to submit (December 2008) in-use stability study covering 100 days. Further, the Applicant commits to provide in-use stability results concerning minimum one batch stored near to the end of the proposed shelf-life period. 7/7

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