PUBLIC ASSESSMENT REPORT Scientific Discussion. ASPROFLASH 500mg, Coated Tablets. Acetylsalicylic acid FR/H/0482/001/DC

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1 Direction NEURHO /DP3 Neurologie-Psychiatrie-Antalgie-Rhumatologie- Pneumologie-ORL-Ophtalmologie-Stups et psychotropes PUBLIC ASSESSMENT REPORT Scientific Discussion ASPROFLASH 500mg, Coated Tablets Acetylsalicylic acid FR/H/0482/001/DC Applicant: Bayer Santé Familiale Date of the PAR: 12/2013 FR/H/0482/001/DC Page 1 of 7

2 Information about the initial procedure: Application/Legal Basis Hybrid application (10.3) Active substance Acetylsalicylic acid Pharmaceutical form coated tablets Strength 500mg Applicant Bayer Santé Familiale EU-Procedure number FR/H/0482/001/DC End of procedure D210 : 17/09/ INTRODUCTION The applicant Bayer Santé Familiale has developed a new tablet formulation for acetylsalicylic acid 500 mg fast release tablet - with the objective of optimizing dissolution in the gastrointestinal tract together with an increased speed of absorption and ultimately faster onset of action without an increase in systemic extent of exposure as compared to the commercial aspirin plain tablet, which serves as the gold standard for comparison. Asproflash 500mg, coated Tablets is applied as a hybrid application (article 10.3 of Directive 2001/83) of Aspirine du Rhone 500 mg, comprimé registered by Bayer Santé Familiale for not less than 6/10 years in the EEA. Based on review of the quality, safety and efficacy data, the decentralised procedure for the Asproflash 500 mg coated tablets was approved on 17 September In this Decentralised procedure, France was acting as reference Member State (RMS). Austria, Belgium, the Czech Republic, Germany, Hungary, Greece, Luxemburg, Poland, Portugal, Romania and Slovenia were the concerned Member states (CMS). The product was approved for the symptomatic treatment for fever and/or mild to moderate pain. The proposed dose and dosage is as follows: Adults and adolescents (aged 16 and older): 1 to 2 tablets with each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 6 tablets. Elderly patients (aged 65 and older): 1 tablet with each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 4 tablets. Adolescents aged years (40-50 kg): 1 tablet with each dose to be repeated as needed after a minimum period of 4 hours. The maximum daily dose should not exceed 6 tablets. Acetylsalicylic acid should not be taken for more than 3 days (for fever) respectively for more than 3-4 days (for pain) unless directed by a physician. Paediatric patients: Acetylsalicylic acid should not be used in children under 12 years (under 40 kg) without a prescription. The recommended daily dose is 60 mg/kg/day, to be divided in 4 to 6 doses, equal to 15 mg/kg every 6 hours or 10 mg/kg every 4 hours. FR/H/0482/001/DC Page 2 of 7

3 2. QUALITY ASPECTS 2.1 Introduction Asproflash 500 mg is presented as coated tablet. List of excipients is as follows: Tablet core: Colloidal silicon dioxide Sodium carbonate anhydrous Coating: Carnauba wax Hypromellose Zinc stearate. Asproflash 500 mg coated tablet is packed in Strips (paper - PE - aluminium - copolymer foil) packed into cardboard packs 2.2 Drug substance Acetylsalicylic acid is a white or almost white, crystalline powder or colourless powder, slightly soluble in water; freely soluble in ethanol (96 per cent). The drug substance is described in the European Pharmacopea. The drug substance manufacturer has a CEP. The control tests and specifications for drug substance are adequately drawn up. Stability studies of the drug substance have been assessed by European Directorate for the Quality of Medicines (EDQM) and the re-test period of 24 months if stored in polyethylene bags inside cardboard drums or big bags, has been granted. 2.3 Medicinal product Pharmaceutical development has been well described. The excipients selected are commonly used for oral solid dosage forms. The aim of the applicant was to develop a tablet with faster dissolution compared to the reference product. Data summarising the information on batch size, manufacturing site and expiration date have been provided. The Certificate of Analyses (COAs) from the biobatches as well as dissolution profiles have been included. The manufacturing process is solid a dry granulation followed by a compression with dry coating. Batch sizes claimed are 9,200,000 tablets or 1,300,000 tablets. The manufacturing process is well described. A flow chart highlighting the different steps and in process controls (IPC s) is provided. Many information about the coating mixture, sampling of the initial blend and the granules, mass uniformity, thickness and friability have been included. A detailed validation protocol has been performed and provided for both batch sizes. The product specifications cover appropriate parameters for this dosage form. Validations of the analytical methods have been presented. However, the proposed limits for Assay at shelf-life and for specified impurities are still to be tightened once the 36 months stability data are available. FR/H/0482/001/DC Page 3 of 7

4 Batch analysis has been presented for three commercial scale batches. The batch analysis results show that the finished products meet the specifications proposed. Packaging of finished drug product consists of strips with white paper, laminated onto an aluminium foil and ionomer (ethylene/methacrylic acid copolymer) as the sealing layer. One individual pouch contains one tablet. 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 proposed shelf-life of 36 months without storage conditions for the drug product was considered acceptable. 3. NON-CLINICAL ASPECTS 3.1 Discussion on the non-clinical aspects The pharmacodynamic, pharmacokinetic and toxicological properties of acetylsalicylic acid are well known. No new non clinical study has been performed for this new formulation and this was considered justified. The non-clinical overview was based on literature review. Environmental risk assessment No specific provisions for use and disposal of the drug are required with respect to environmental risks. Introduction of this new environmental formulation is not assumed to increase significantly the environmental concentration of acetylsalicylic acid. 4. CLINICAL ASPECTS 4.1 Introduction Acetylsalicylic acid is a well-established substance and there are many years of experience to enable safety monitoring via routine risk minimisation. Acetylsalicylic acid is a well established treatment for pain, flu syndrome and fever indications. The 500 mg dose of aspirin is an approved OTC single dose. Therefore, in line with VOLUME 9A (I.3) of the Rules Governing Medicinal Products in the European union Guidelines on Pharmacovigilance for Medicinal Products for Human Use no risk management plan will be provided. This was considered acceptable. 4.2 Pharmacokinetics Three pharmacokinetics studies and a food interaction study have been conducted; Key features of these studies are presented in the following table. Characteristics of bioavailability studies FR/H/0482/001/DC Page 4 of 7

5 Based on the data of the bioequivalence studies, the test product fast release acetylsalicylic acid 500 mg tablet can be considered bioequivalent with the reference product Aspro 500 mg effervescent tablet, with respect to rate and extent of absorption of acetylsalicylic acid, under fasting conditions. Summary of the main pharmacokinetic parameters of the new formulation of ASA Absorption: This formulation provides fast pain relief in conditions of acute mild to moderate pain. The fast pain relief is attributed to a quick onset of action due to a decreased time to maximum plasma concentration. The small particle size of the active ingredient acetylsalicylic acid and an effervescent component provide very rapid dissolution of the product. Metabolism. Following oral administration, gastrointestinal absorption of acetylsalicylic acid from this formulation is very rapid and complete. During and after absorption acetylsalicylic acid is converted into its main active metabolite salicylic acid. Mean maximum plasma levels are reached at approximately 17.5 minutes for acetylsalicylic acid and approximately 45 minutes for salicylic acid as measured in bioavailability studies. Compared to conventional acetylsalicylic acid tablets (Aspirin ), the time to maximum plasma concentration of acetylsalicylic acid and salicylic acid was decreased by a factor of 2.6 and 4.0, respectively, with this formulation. A subsequent, clinically faster onset of action has been demonstrated in comparative clinical efficacy studies with over 1000 patients with postoperative dental pain. In these studies, time to first perceptible pain relief, time to first perceptible pain relief confirmed and time to meaningful pain relief compared to conventional acetylsalicylic acid tablets was statistically significantly improved whereas the overall efficacy (duration and intensity of the effect) was not changed. Compared to conventional acetylsalicylic acid tablets, the time to meaningful pain relief was twice as fast (49 minutes compared to 99 minutes). Distribution: Both acetylsalicylic acid and salicylic acid are extensively bound to plasma proteins and are rapidly distributed throughout the body. Salicylic acid passes into breast milk and crosses the placenta. Elimination: Salicylic acid is eliminated predominantly by hepatic metabolism. Its metabolites are salicyluric acid, salicylic phenolic glucuronide, salicylacyl glucuronide, gentisic acid, and gentisuric acid. The elimination kinetics of salicylic acid is dose-dependent, as metabolism is limited by liver enzyme capacity. The elimination half-life therefore varies from 2 to 3 hours after low doses to up to about 15 hours at high doses. Salicylic acid and its metabolites are excreted mainly via the kidneys. FR/H/0482/001/DC Page 5 of 7

6 4.3 Clinical aspects: efficacy and safety To sustain the following claimed indication, i.e. Treatment of symptomatic treatment for fever and/or mild to moderate pain such as headache, flu syndrome, dental pain, muscular pain, the applicant provided two Phase 3 efficacy studies with the new tablet formulation in an accepted model of pain which is dental pain due to impacted third molars: - Pivotal study (PH-36453) used a dose of 1000 mg acetylsalicylic acid (2 x 500 mg coated tablets, to-be-marketed formulation). - Supportive study (PH-36452) used a dose of 650 mg of acetylsalicylic acid (2 x 325 mg, identical formulation). The dose of 650 mg is within the proposed dose range of 500 mg to 1000 mg for an individual dose and therefore was considered as supportive for the demonstration of efficacy of the fast release tablet. A review of the relevant literature (clinical pharmacology, clinical efficacy and clinical safety) to support the claimed use in headache and flu syndrome (sore throat, common cold an fever; miscke pain) was also performed. Studies PH and PH met their identical primary endpoints and demonstrated a statistically significant effect of fast-release acetylsalicylic acid vs. the commercial acetylsalicylic acid plain tablet and vs. placebo. Perceptible and meaningful PR occurred faster in comparison to regular aspirin (plain tablets) and placebo. This conclusion was supported by the outcome of all secondary endpoints in both studies. 5. OVERALL DISCUSSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION From a quality, non-clinical and the clinical point of view no major objections were raised by the RMS to approval of Asproflash 500mg, coated tablets in adults and children over 12 years (40kg or more Children under 12 years/40 kg : should not be used without a prescription). The provided data support the use of this new formulation in the claimed indication: symptomatic treatment for fever and / or mild to moderate pain. This indication has been retained considering that the details of the clinical situations is not mandatory in the SmPC and can only be mentioned in the Patient Information Leaflet (PIL). The proposed posology was also endorsed. FR/H/0482/001/DC Page 6 of 7

7 However, at Day 120 of the procedure, a major public health concern was raised by CMS DE regarding the potential consequences on Benefit / Risk balance of the higher Cmax and shorter Tmax for Asproflash 500 mg coated tablet compared to Asproflash 500 mg plain tablet. In its response, the Applicant refers to the studies provided in this application together to the studies performed with other effervescent aspirin containing products. The Applicant safety database for aspirin containing products has also been analysed. These data were considered sufficient to conclude that the pharmacokinetic characteristics of this product would not adversely affect its safety and the issue was solved. The approved therapeutic indication for this new tablet formulation is the symptomatic treatment for fever and/or mild to moderate pain. FR/H/0482/001/DC Page 7 of 7

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