Public Assessment Report. Scientific discussion
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1 Public Assessment Report Scientific discussion Dropodex 0.1% w/v eye drops, solution (Dexamethasone sodium phosphate) MT/H/0157/001/DC Date: 3 rd May, 2013 This module reflects the scientific discussion for the approval of Dropodex 0.1% w/v eye drops, solution. The procedure was finalised on Day 210, the 7 th of January, 2013.
2 I. INTRODUCTION Based on the review of the quality, safety and efficacy data, the Member States have granted a marketing authorisation for Dropodex 0.1% w/v eye drops, solution, from Moorfields Eye Hospital NHS Foundation Trust trading as Moorfields Pharmaceuticals. The product is indicated for non-infected, steroid responsive, inflammatory conditions of the eye. A comprehensive description of the indications and posology is given in the SmPC. The marketing authorisation has been granted pursuant to Article 10(3) of Directive 2001/83/EC. The reference product for this application is Monofree dexamethason 1mg/ml eye drops authorised in the Netherlands in The MAH is Théa Pharma SA. The CMSes for this procedure were Ireland and the United Kingdom. The product is a prescription only medicine. II. QUALITY ASPECTS II.1 Introduction Pharmaceutical form: eye drops, solution Formulation: Active ingredient dexamethasone sodium phosphate Excipients - sodium chloride, disodium edetate, disodium phosphate dodecahydrate (E339) and water, purified. Container system: Dropodex is available in 0.4 ml transparent low density polyethylene single-dose units. Each pre-formable PET metal/pe transparent and PET metal/pe peelable sachet contains 5 single-dose units. 20 single-dose units are packed into one carton. II.2 Drug Substance Pharmacological classification: ATC code: S01 BA01 Pharmacotherapeutic Group: Corticosteroids, plain Dexamethasone sodium phosphate is a well known substance described in the Ph. Eur. monograph 01/2008: Reference is made to a valid Ph.Eur. certificate of suitability for the active substance, namely R0-CEP Rev 00, issued by the EDQM (granted 23 October 2008). The manufacturer of the drug substance is Symbiotica Speciality Ingredients Sdn Bhd, Kulim Kedah Malaysia. Symbiotica Speciality Ingredients Sdn Bhd, Seberang Jaya, Malaysia, has been granted the certificate of suitability, R0-CEP PAR Scientific discussion 2/6
3 Rev 00, for Dexamethasone Sodium Phosphate, issued by the EDQM (23 October 2008). The control tests and specifications for the drug substance are adequately drawn up. The drug substance is considered to be suitably controlled by its Ph. Eur. monograph if supplemented with the additional tests listed in the annex of the CEP. The CEP includes a retest period of 3 years (if stored in a double low-density polyethylene bag, with two dessicant bags, all sealed in an aluminium foil laminate and then placed inside a high density polyethylene drum). The drug substance specifications are in line with the Ph. Eur. and with the additional tests given in the CEP. All batch analytical data complied with the limits set out in the CEP and with the current Ph.Eur. monograph for Dexamethasone Sodium Phosphate. II.3 Medicinal Product The pharmaceutical development of the product has been described, the choice of excipients is justified and their functions explained; excipients common to pharmaceutical manufacture and of pharmacopoeial quality have been selected. The manufacture of the drug product together with in-process controls has been adequately described. The proposed finished product specifications are in compliance with the general pharmacopoeial requirements and the batch data submitted. Validation of the analytical methods has been presented. Batch analysis has been performed on three production scale batches of the finished product; batch analysis results show that the finished product meets the specifications proposed. Long term stability data and conditions employed during the stability studies indicate that the medicinal product passes all specifications at 24 months. Thus a shelf life of 30 months, with the drug product not to be stored above 25ºC can be granted. All issues raised during the procedure with respect to drug product have been adequately resolved. III. NON-CLINICAL ASPECTS Pharmacodynamic, pharmacokinetic and toxicological properties of dexamethasone are well known. As dexamethasone is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. Overview based on literature review is, thus, appropriate. The expert report on the non-clinical pharmacology, pharmacokinetics and toxicology provides an adequate overview of preclinical investigations into the mechanistic activity and toxicity of dexamethasone. The report supports the non-clinical texts as presented within the applicant s proposed product information and the reference product s latest approved prescribing texts. III.1 Ecotoxicity/environmental risk assessment (ERA) The applicant performed a preliminary screening and exposure estimation based on requirements as laid out within the Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use (EMEA/CHMP/SWP/4447/00 corr 1, June 2006). The Predicted Environmental Concentration (PEC) value was calculated as falling below the established threshold: 0.01 μg/l and it was, therefore, concluded that it would be unlikely that Dexamethasone 0.1% w/v Eye Drops would represent a risk for the environment following its prescribed usage in patients. PAR Scientific discussion 3/6
4 The absence of an ERA is justified based on the fact that dexamethasone is not a new active substance and the formulation s excipients are widely used in the manufacture of pharmaceuticals. The current application concerns a generic product which is meant to substitute a percentage of total prescriptions for the innovator product and is therefore not expected to increase the amount of active substance that is released into the environment. This is acceptable IV. IV.1 CLINICAL ASPECTS Introduction The clinical overview report covers the product rationale, overview of biopharmaceutics, pharmacology, efficacy, safety and benefits and risks conclusions. The report refers to 20 publications up to year The MAH has not conducted any clinical trials and a literature review is submitted to support the application. The proposed product is of the same qualitative composition of active substance and excipients and the same pharmaceutical form as the reference medicinal product. IV.2 Pharmacokinetics No new data has been submitted by the applicant. When administered topically to the eye, dexamethasone is absorbed into the aqueous humour, cornea, iris, choroid, ciliary body and retina. Absorption of dexamethasone phosphate into aqueous humour, vitreous and serum of patients has been widely studied in several published articles. The proposed product is an ophthalmic solution. IV.3 Pharmacodynamics No new data has been submitted by the applicant. When administered topically to the eye, dexamethasone is absorbed into the aqueous humour, cornea, iris, choroid, ciliary body and retina. Absorption of dexamethasone phosphate into aqueous humour, vitreous and serum of patients has been widely studied in several published articles. IV.4 Clinical efficacy No new data has been submitted by the applicant. Dexamethasone is a potent corticosteroid which suppresses the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body s defence mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. The strong anti-inflammatory and immunosuppressive effects of glucocorticoids are mediated primarily by the cytosolic glucocorticoid receptors, which act to increase the expression of PAR Scientific discussion 4/6
5 anti-inflammatory proteins and decrease the production of pro-inflammatory proteins. Glucocorticoids also exert a number of non genomic, rapid actions independent of gene transcription regulation, including the inhibition of the release of inflammatory PGE2 and the blocking of T cell receptor signalling. IV.5 Clinical safety The use of dexamethasone eye drops has been well established for a number of years and the applicant has provided an adequate number of publications confirming the safety. There is no proposed indication or data for use in children apart from three bibliographic citations of the increase in IOP when the product is used in children over the age of 2. A warning on long term use of dexamethasone in children has been included in section 4.3 of the SmPC however there is no efficacy data as mentioned above for the use of the product in children above the age of 2. A number of warnings have been added to the SmPC in section 4.4 based on publicly available data of other ophthalmic dexamethasone products on the market and the chosen European Reference Product. IV.6 Discussion on the clinical aspects The proposed product is a topical solution. It has the same concentration of API, dosage regimen and method of administration as the chosen ERP. The product is administered topically to the eye and acts locally. This has been discussed by the clinical expert and supported by adequate bibliography in the clinical overview. Systemic uptake after topical application of dexamethasone as used in the clinical practice is low such that even after prolonged use a change in the cortisol levels occur but the levels are still within the physiological ranges. (Roters et al.1995) Topical ophthalmic corticosteroid dosage is significantly less than when the drug is given systemically and hence clinical evidence of systemic absorption usually does not occur. Topical preparations distribute throughout the area of application; ophthalmic preparations distribute into the local tissues [Clinical Pharmacology 2009]. Systemic bioavailability of dexamethasone after topical application depends on the state of the skin at the application site. The above fulfils the requirements for waiver of bioequivalence study for locally acting locally applied products as stated in Appendix II of the Guideline for investigation of Bioequivalence. Adequate justification for the lack of clinical studies in spite of the chosen legal basis (10.(3) hybrid application) has been provided. The applicant has stated the reasons as to why the proposed product fulfils the criteria for an Article 10(3) hybrid application and gave reasons for the lack of a clinical study by requesting a waiver and justifying how the proposed product meets the criteria of the waiver V. OVERALL CONCLUSION, BENEFIT/RISK ASSESSMENT AND RECOMMENDATION The application contains an adequate review of published clinical data supporting the efficacy and safety of Deximoor 0.1% w/v eye drops in the claimed indications. The benefit/risk for Deximoor 0.1% w/v eye drops, solution is positive. PAR Scientific discussion 5/6
6 Based on the review of the data on quality, safety and efficacy, the RMS considers that the application for Deximoor, in the treatment of non-infected, steroid responsive, inflammatory conditions of the eye, is approvable. Specific Obligations: Area 1 Quality Quality Description Laboratories Unimed undertakes to complete the ongoing stability studies (long term stability). All data and generated documentation will be available to the authorities. Once the marketing authorisation of the drug product is granted, the Quality Assurance Department in association with the Production Department undertakes to place samples from the first product batch annually on the ongoing stability study. Applicant has committed not to market the medicinal product until the outcome of GMP inspection for the drug product manufacturer is known and the entry is entered into EudraGMP. User Consultation The package leaflet 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 PIL was English. 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. PAR Scientific discussion 6/6
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