7 &8) Seroflo Traning Module-Product Knowledge (7 & 8).pptx

Product Knowledge of Overview of commonly used ICS/LABA Fluticasone Propionate/Salmeterol (Seroflo) Mechanism of Action (MOA): Salmeterol: It is a highly selective β2‐adrenoceptor (LABA) agonist with, long‐acting bronchodilator activity, inhibition of the release of hypersensitivity mediators f...

Product Knowledge of Overview of commonly used ICS/LABA Fluticasone Propionate/Salmeterol (Seroflo) Mechanism of Action (MOA): Salmeterol: It is a highly selective β2‐adrenoceptor (LABA) agonist with, long‐acting bronchodilator activity, inhibition of the release of hypersensitivity mediators from mast cells. Salmeterol is at least 50times more selective for β2‐adrenoceptors than salbutamol (albuterol). Binding of salmeterol to the β2‐adrenoceptor results in activation of intracellular adenyl cyclase, which catalyzes the conversion of adenosine triphosphate to cyclic adenosine monophosphate (cAMP).  Increased cAMP levels lead to bronchial smooth muscle relaxation.  Other actions of salmeterol that may be of relevance to COPD, include reduction of cytokine secretion, inhibition of antigen‐induced increases in vascular permeability, improved mucociliary clearance and improved ciliary beat frequency.     Fluticasone Propionate:  inhibit inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages.  inhibit the secretion of histamines, cytokines, and leukotrienes that are commonly released with asthma and allergic responses Advantages:      Low side effect vs oral corticosteroids Improve the FEV1, reduce exacerbation and achieving the control definition acc. To GINA guideline Affordable cost vs the cost of emergency/hospitalization. Achieve the synergistic effect Two dosage forms DPI and MDI Disadvantages:    Oral Infection (Candiasis) Tremors and increase palpitation Difficulty in usage (compliance) Comparison Between the two major molecules Fluticasone Propionate/Salmeterol (Seroflo) Budesonide/Formoterol (Symbicort) ROA:  Inhaled (2 forms DPI & MDI) ROA:  Inhaled (1 form DPI) MOA:  inhibit inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages.  inhibit the secretion of histamines, cytokines, and leukotrienes that are commonly released with asthma and allergic responses  activates glucocorticoid receptors and inhibits lung eosinophilia  Selective LABA; stimulates intracellular adenyl cyclase increased cAMP levels causing bronchial smooth muscle relaxation.  inhibits release of mediators of immediate hypersensitivity from cells, especially from mast cells MOA:  inhibit neutrophil apoptosis and demargination.  inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives  inhibit NF-Kappa B and other inflammatory transcription factors  promote anti-inflammatory genes like interleukin-10  stimulates intracellular adenyl cyclase increased cyclic adenosine monophosphate levels, causing relaxation of bronchial smooth muscle.  inhibition of release of mast cell mediators Onset Of Action and Improvement Sign:  30 Minutes  1 to 2 weeks Duration of Actions  12 hours Onset Of Action and Improvement Sign:  15 Minutes  1 to 2 weeks Duration of Actions  12 hours What is is related to the SFC with two forms DPI & MDI for bronchial asthma and COPD as a controller to achieve the total control, improving patients’ morning PEF and lung function improvements were accompanied by a considerable increase in the percentage of both symptom and rescue‐free days and nights. Ciphaler (DPI) • Seroflo Ciphaler: • 50/250 mcg • 50/500 mcg. Inhaler (MDI) • Seroflo inhaler: • 25/125 mcg • 25/250 mcg. Approved Indication SEROFLO is indicated in the regular treatment of asthma, where use of a combination (long-acting beta2-agonist and inhaled corticosteroid) has been found to be appropriate, and in patients with COPD • Asthma Adults and Adolescents (12 years and older) SEROFLO 125 INHALER: Two inhalations twice daily SEROFLO 250 INHALER: Two inhalations twice daily SEROFLO-250 CIPHALER: One inhalation twice daily SEROFLO-500 CIPHALER: One inhalation twice daily • Chronic Obstructive Pulmonary Disease (COPD) SEROFLO 125 INHALER: Two inhalations twice daily SEROFLO 250 INHALER: Two inhalations twice daily SEROFLO-250 CIPHALER: One inhalation twice daily SEROFLO-500 CIPHALER: One inhalation twice daily Note: SEROFLO INHALER may be used with a Zero stat/ Zero stat VT Spacer device in patients who find it difficult to synchronize aerosol actuation with inspiration of breath. Mechanism Of action Bronchoconstriction ARM Salmeterol: • • Salmeterol is a selective long-acting (12 hour) β2 Inflammation ARM Fluticasone propionate: • Fluticasone propionate given by inhalation at adrenoceptor agonist with a long side chain which recommended doses has a glucocorticoid anti- binds to the exo-site of the receptor. inflammatory action within the lungs. Salmeterol produces a longer duration of • Resulting in reduced symptoms and exacerbations of bronchodilation, lasting for at least 12 hours, than asthma, with less adverse effects than when recommended doses of conventional short-acting β2 corticosteroids are administered systemically. agonists. Pharmacokinetics: Absorption and Distribution  The Cmax reached within 5 minutes.  No food intake affects absorption of Seroflo .  Fluticasone propionate is highly lipid soluble with a high first‐pass metabolism; therefore, any part of the dose that is swallowed contributes minimally to systemic exposure (<1%)  The percentage of fluticasone propionate bound to human plasma proteins averages 91% and 96% for salmeterol.  Terminal half-life estimates of fluticasone propionate for pMDI, DPI, and fluticasone propionate CFC inhalation aerosol were similar and averaged 5.6 hours. Clinical trials Clinical trial overview Description Patient Population Treatment group Goal Study • A 1‐year, randomized, stratified, double‐blind, parallel‐group study, comparing fluticasone propionate and salmeterol/fluticasone as a combination • A total of 5068 above 18 years old patients from 826 centers in 44 countries were screened; 3421 qualified for inclusion. Phase 1 was completed by 3039 patients; phase 2 was completed by 2890 patients. • • The intent-to-treat population comprised 688 patients (344 per treatment arm) with a mean age of 45 years • • One group takes ICS only fluticasone 500 mcg twice daily The second group takes salmeterol/fluticasone 50/500 mcg twice daily Concept Study • A 1‐year, multicenter, randomized, double‐blind, double‐dummy comparison of a stable dosing regimen of salmeterol/fluticasone propionate with an adjustable maintenance dosing regimen of formoterol/budesonide in adults with persistent asthma. • Patients were randomized to receive 1 inhalation of SAL/FP 50/250 microg BID 2 inhalations of FOR/BUD 6/200 microg BID, both delivered via dry powder inhaler devices Clinical trial overview Goal Study A 1‐year, randomized, stratified, double‐blind, parallel‐group study of 3,421 patients with uncontrolled asthma compared fluticasone propionate and salmeterol/fluticasone in achieving two rigorous, composite, guideline‐based measures of control: totally and well‐controlled asthma Treatment was stepped‐up until total control was achieved (or maximum 500 μg corticosteroid twice a day). Goal Study Randomization • These patients were then randomized and stratified according to baseline treatment in previous 6 months.  Stratum 1. Corticosteroid naïve or 'corticosteroid-free'  Stratum 2. <500 mcg BDP daily or equivalent  Stratum 3. >500 - <1000 mcg BDP or equivalent Goal Study Design Stratified, randomized, double-blind, parallelgroupnumber studyof patients recruited in a trial on Largest asthma ever N=5068 N=1647 excluded N= 3,421 826 centers 44 countries N=3039 N=2890 Patients achieving TC at any time during Phase I were placed into Phase II & continued with the same dose. Goal Study inclusion criteria Inclusion Criteria:  Adult asthma patient from 18 to 56 years old.  Patients who did not achieve at least 2 well controlled weeks in the 4-week run-in period were stratified according to their medication use in the 6 months before screening stratified to 3 strata’s acc. To their use  Stratum 1. Corticosteroid naïve or 'corticosteroid-free'  Stratum 2. <500 mcg BDP daily or equivalent  Stratum 3. >500 - <1000 mcg BDP or equivalent Goal Study Objective Objectives:  To study whether patients with asthma can achieve control as defined by the guidelines  Compared the efficacy and safety of stepwise increases of salmeterol/fluticasone with fluticasone in achieving 2 predefined composite measures of asthma control Goal Study Outcome • Primary Outcome: Over all strata’s  Total Control Achieved with SFC vs FP 31% vs 19% Over all  Achieving GINA Guideline-Defined Well Controlled strata’s Asthma 63% VS 50% Goal Study Outcome • Secondary Outcome: Over all  Maintenance of Control: Symptom-Free Daysstrata’s Over 1 Year in 75% vs 52% Over all strata’s  Maintenance of Control: Improved Lung Function Over 1 Year 58% vs 17% Goal Study Conclusion • Conclusion: 31% patients achieved Total control and 63% patients were Well  At end of 1 year, controlled  Fluticasone Propionate/Salmeterol might be considered the preferred treatment for all patients with uncontrolled asthma  Patients achieving asthma control, maintain a similar level of control with regular, stable dosing, with little likelihood of losing control Clinical trial overview Concept Study 1‐year, multi center, randomized, double‐blind, double‐dummy study in adult patients with symptomatic asthma that was not controlled by therapy with 200 to 500 pg/d inhaled corticosteroid (ICS) plus a long‐ acting beta2‐agonist, or with >500 to 1000 iag/d ICS alone. Concept Study Design This was a randomized, double-blind, double dummy, parallel-group study carried out at 91 centers in 15 countries. Inclusion Criteria • • • Male or female outpatients aged >18 and <70 years with a documented clinical history of asthma Forced expiratory volume in 1 second (FEV1) between 60% and 90% of the predicted normal value were eligible for enrollment. All patients had used either an ICS at a dose equivalent to 200 to 500 mcg/d beclomethasone dipropionate (BDP) combined with a LABA, or an ICS alone at a dose equivalent to >500 to 1000 mcg/d BDP for >12 weeks before enrollment Randomization Done by: interactive Voice response system (IVRS) Phase 1 Phase 2 The double-blind treatment period was split into 2 phases: • Phase 1: weeks 1 through 4, during which the dose delivered from both devices was kept constant. • Phase 2: weeks 5 through 52, during which the dose delivered via Diskus remained unchanged but the dose delivered via Turbuhaler was initially reduced to 1 inhalation BID and subsequently adjusted according to the physician guided. Concept Study Objective Objectives:  To study between the 2 combination (SFP & B/F) in terms of:  Percentage of symptoms free days.  Percentage of nighttime awakenings due to asthma  Rescue free days.  Daily asthma symptom scores, morning PEF  Percentage of nighttime awakenings due to asthma  Percentage of weeks with well-controlled asthma Concept Study Outcome • Fluticasone Propionate/Salmeterol offer than Budesonide/Formoterol 33 symptom free days more Concept Study Outcome  Over all were 48% fewer exacerbations with stable dosing of Fluticasone Propionate/Salmeterol than with Budesonide/Formoterol  Fluticasone Propionate/Salmeterol reduce the Hospitalization by Budesonide/Formoterol 20% more the  Fluticasone Propionate/Salmeterol reduce the use of Oral Prednisolone by the Budesonide/Formoterol 30.5% more Concept Study Conclusion  Fluticasone Propionate/Salmeterol offer Budesonide/Formoterol 33 symptom free days more than  Over all were 48% fewer exacerbations with stable dosing of Fluticasone Propionate/Salmeterol than with Budesonide/Formoterol  Fluticasone Propionate/Salmeterol reduce the Hospitalization by Budesonide/Formoterol 20% more the  Fluticasone Propionate/Salmeterol reduce the use of Oral Prednisolone by the Budesonide/Formoterol 30.5% more Seroflo Market Understanding Antiasthma & COPD Total Market 4 6 6 0 1 2 T otal 9 R3 Market 2022 0 0 %  In term of volume the total R3 Antiasthma and COPD Prod. market was operating by 21,221,073 units with growth 36.7% YOY2022.  Divided between two sectors private and government: Private represents 16,560,944 (78%) units vs public represents 4,660,129 (22%) units.  The Private sector is growing by 46.9% YOY2022 and the public sector is growing by 9.8% YOY2022  The molecules included:         ICS/LABA ICS ICS/LABA/LAMA LABA LABA/LAMA LAMA Montelukast SABA Private  The private market is driving the growth of the total market. Total R3 Market 36.7% 21,221,07 3 15,519,22 6 R3 Antiasthma & COPD Prod/Public 4,660,129 9.8% 1 6 5 6 Governmental 0 9 4 4 0 0 % R3 Antiasthma & COPD Prod/Private 16,560,94 4 11,276,84 1 46.9% 4,242,385 2021 Units 2022 Units 2021 Units 2022 Units 2021 Units 2022 Units Antiasthma ICS Combination Total Market  Total Market of Combination ICS/LABA operating by 2,819,055 units with MS 2022 Total Combination growth 24% YOY2022.  For antiasthma distinguishing market of ICS/LABA combination therapy represented by YOY2022. 1,441,299 units in private with growth 26.6%  And 1,377,755 units in government with growth  Represented by 5 molecules:      0 19.1% YOY2022. 0 Budesonide/Formoterol Fluticasone/Salmeterol Fluticasone/Formoterol Fluticasone furoate/Vilanterol Beclomethasone/Formoterol). 0  Leaded By Budesonide/Formoterol (30% YOY2022) followed by Fluticasone/Salmeterol (15% YOY2022). 0  The ICS/LABA combination total market is driven by the private market. Adult Asthma Comb. 2,819,054 2,276,472 2021 Units 24 % Adult Asthma Comb./Private 1,441,299 1,138,268 2022 Units Adult Asthma Comb./Public 2021 Units 26.6 % 1,377,755 1,138,204 2022 Units 2021 Units 19.1 % 2022 Units 0 Antiasthma ICS Combination Total Private Market Total Market MS 2021 MS 2022 Gr 2022 EI Adult Asthma Comb. - - 24 - Beclomethasone/Formoterol 2 3 67 279 Budesonide/Formoterol 40 42 30 125 9 7 -11 -145 4 7 122 508 44 41 15 62.5 Fluticasone furoate/Vilanterol Fluticasone propionate/Formoterol Fluticasone propionate/Salmeterol Public Market MS 2021 MS 2022 Gr 2022 EI - 27 - Adult Asthma Comb. Adult Asthma Comb. MS 2022 MS 2021 Gr 2022 248 Beclomethasone/Formoterol - Budesonide/Formoterol 44 48 38 141 Budesonide/Formoterol 36 36 21 100 Fluticasone furoate/Vilanterol Fluticasone propionate/Formoterol Fluticasone propionate/Salmeterol 5 4 19 70.4 Fluticasone furoate/Vilanterol 9 14 -20 -95 4 3 0 1.1 Fluticasone propionate/Formoterol 11 4 228 1,085 43 39 14 52 Fluticasone propionate/Salmeterol 43 45 15 71 Asthma Market Public 1,377,755 1,138,204 696,066 1,152,717 1,004,770 215,490 200,547 192,60590,505 505,359 79,572 47,608 412,740 62,61042,277 42,391 52,555 d t ul A hm st a B C om ud es b. i on de u Fl or /F tic a m er ot n so e f 2021 Units 2022 Units tic V e/ at o as 514,301 158,156 162,935 129,99548,228 ol o ur u Fl 2022 Units 592,057 497,547 560,660 490,469 A 2021 Units ne 2021 Units ila er nt o pr pi ol a on u Fl tic te or /F o as ne m er ot o pr pi Public). 1,152,717 and GR 15% YOY2022 with EI 62.5 ol a on 2022 Units  From the reading of the ICS Combination total market that private market is driving the market growth, although the public sector is still growing but not as fast as the total market.  In term of units the Budesonide/Formoterol as a molecule is Market leader with 1,193,613 and GR 30% YOY2022 with EI 125 (Total Market-Private The 2nd molecule is SFP with - 67 1,090,700 79,572 47,608 - 6 1,361,727 1,193,613 918,099 - 4 Asthma Market Private 2,276,472 21 Beclomethasone/Formoterol 2021-2022 Asthma Combination Market 2,819,054 - EI te a /S le m ro et l Antiasthma ICS Combination Market Private Total MS 2021 Gr 2022 EI - 27 - MS 2021 Gr 2022 EI - 24 - 57 23 96 DPI 72 72 26 96 DPI 104 MDI 28 28 28 103 MDI 58 MDI Public MS 2022 MS 2022 Adult Asthma Comb. DPI MS 2021 42 43 25 Adult Asthma Comb. Total EI - 21 - 61 60 18 86 39 40 25 112 Public 1,441,299 2,276,472 Gr 2022 Adult Asthma Comb. Private 2,819,054 MS 2022 1,377,755 1,138,268 1,138,204 1,037,608 1,620,279 1,316,247 824,084 824,162 696,050 1,198,775 553,593 442,154 960,225 403,691 314,184 Adult Asthma Comb. DPI 2021 Units MDI 2022 Units Adult Asthma Comb. DPI 2021 Units MDI 2022 Units Adult Asthma Comb. DPI 2021 Units MDI 2022 Units  The Asthma ICS Combination market is divided into two dosage forms MDI (25% YOY2022) and DPI (23% YOY2022).  The growth driver for the MDI is private market (28% YOY2022), although the public market is also growing (25% YOY2022)  The reason behind the growth of MDI is the reflection of wasfaty in the private market and in the public sector as guild lines prefer the usage of MDI with spacer than DPI due to the better drug deposition.  The growth driver for the DPI is private market (26% YOY2022), although the public market is also growing (18% YOY2022). Antiasthma ICS Combination Market (B/F Market) Total Private MS 2021 MS 2022 Adult Asthma Comb. B/F Symbicort 160 Bufomix 160 40 93 7 MS 2022/Total Gr 2022 MS 2021 EI - - 24 - 86 14 42 36 6 30 20 158 126 67 525 Ad t ul t As Bu rm Fo / e id n so de - - 27 - 48 41 38 31 142 83 Bufomix 160 12 16 8 84 222 B/F Private ol er t o 2021 Units m Sy rt co bi 16 0 m fo Bu ix 16 696,066 584,427 505,359 444,609 Ad 2022 Units t ul th As m a m Co d Bu b. rm Fo / de ni o es Adult Asthma Comb. B/F Symbicort 160 Bufomix 160 Public MS MS 2022 2022/Total Gr 2022 EI 21 36 99 1 88 12 36 32 4 21 8 1,024 98 38 4984 B/F Public 1,138,204 1,138,268 0 MS 2021 1,377,755 1,441,299 1,193,613 1,023,791 918,099 852,173 169,822 65,926 a EI 84 2,276,472 hm Gr 2022 44 88 B/F Total b. MS 2022/Total Adult Asthma Comb. B/F Symbicort 160 2,819,054 m Co MS 2022 ol er t o 2021 Units m Sy rt co i b 16 497,547 407,564 439,364 412,740 111,639 60,750 0 m fo u B ix 16 58,183 5,176 0 Adult Asthma Comb. 2022 Units  As a reading the BF market is growing 30% YOY2022 in both sectors (Private 38% YOY2022 & Public 21% YOY2022) and gained 2% MS with EI 126  On the level of products Symbicort (AstraZeneca) is losing market share in both sectors (Private 4% & Public 11%) which is gained by the Bufomix (Hikma) Budesonide/ Symbicort Formoterol 160 2021 Units 2022 Units Bufomix 160 Antiasthma ICS Combination Market (SFP) Private Total MS 2021 MS 2022 Adult Asthma Comb. SFP Seretide Airtec-SF 48 40 3 46 26 19 Gr 2022 MS 2021 EI - 24 20 -20 671 84 -97 3,344 Adult Asthma Comb. SFP Seretide Airtec-SF 25.7 MS 2,276,472 19 MS Fluticasone propionate/ Salemetrol 2021 Units Seretide - 15 31 106 55 216 730 Adult Asthma Comb. SFP Seretide Airtec-SF 516,741 524,877 Gr 2022 EI - - 21 - 52 17 35 50 46 4 25 -56 924 119 -224 3,693 Public Market 715064 571945 494,188 376,169 524183 Adult Asthma Comb. Fluticasone propionate/ Salemetrol 2021 Units (20% YoY2022) Seretide Airtec-SF 2022 Units and driven by the Airtec which is growing totally by in both sectors Private and Public and gaining MS by 34% mainly driven by the public sector  Airtec is preforming well in the private sector and it is dominated by Seretide.  Seretide is loosing MS by 14% mainly from the public sector to Airtec. 481304 230472 46993 43,573 21,128 2022 Units  As shown that the market of SFP is growing MS 2021 1138204 591,905 Airtec-SF MS 2022 1377755 68,121 Adult Asthma Comb. 27 1,138,268 900,352 724,660 EI 1,441,299 1,306,969 1,088,686 41 34 3 Gr 2022 Private Market Total Market 2,819,054 45 33 2 Public MS 2022 Adult Asthma Comb. Fluticasone propionate/ Salemetrol 2021 Units (671% YOY2022) and Seretide 2022 Units Airtec-SF Antiasthma ICS Combination Market (Seretide) Total MS 2022 MS 2021 GR 2022 12 -20 19 -6 Seretide 250 -24 -30 Seretide Total Seretide 250 18 Seretide 125 8 34 7 36 Seretide 250/25 32 37 Seretide 500 MS 2022 MS 2021 Seretide 31 Seretide 24 Seretide 250 Seretide 125 10 33 13 28 7 52 Seretide 125 11 4 38 Seretide 250/25 31 33 24 Seretide 250/25 33 22 21 Seretide 500 Private 900,352 6 4 43 -56 3 -44 -60 29 -62 Public 524,183 494188 724,660 GR 2022 MS 2022 MS 2021 GR 2022 Seretide 500 Total 376169 230,472 326,288 328,893 248,668 130,559 109,555 63,963 60,254 Seretide Total Public Private Seretide 250 Seretide 500 2021 Units Seretide 125 2022 Units 231,215 Seretide 250/25 104256 83941 Seretide Seretide 250 51290 47934 Seretide 500 2021 Units 220,801 160730 154278 124747 105487 87,938 26,303 16,029 25,614 8,964 Seretide 125 Seretide 250/25 2022 Units  All SQs are loosing MS except Seretide 125 (MDI) in Private Sector & Seretide 250 (DPI) in the Public sector  In term of Public sector Airtec-SF (Combiwave) is gaining MS from Seretide (MDI)  In term of Private sector the BUD/FOR is gaining MS from SFP market. 204,146 Seretide Seretide 250 Seretide 500 2021 Units Seretide 125 2022 Units 76,937 Seretide 250/25 Antiasthma ICS Combination Market (Combiwave)  AirTec MDI with mainly 2 doses MS The MDI represents: 17% MS from the total Asthma market and  Gaining MS by 34%, which is mainly driven by the public market as it is gained by mainly by AirTec 55% MS 250 from the total SFP.  Mainly this MS gaining is from Seretide MDI in the public sector, although also AirTec starts to gain some MS from Seretide in the private sector. Total Private MS 2022 SFP Airtec-SF Airtec-SF 125 Airtec-SF 250 MS 2022 MS 2021 Gr 2022 40 24 9 6 5 1 SFP Airtec-SF Airtec-SF 125 Airtec-SF 250 25 671 531 628 Total Public MS 2021 Gr 2022 4 15 106 7 4 3 1 2 MS 2022 SFP Airtec-SF Airtec-SF 125 Airtec-SF 250 264 37 Private 1,306,969 1,088,686 MS 2021 Gr 2022 40 8 924 566 14 8 2,720 67 1 924 Public 715,064 591,905 516,741 571,945 481,304 524,877 289,494 310,276 68,121 SFP Airtec-SF 2021 Units 49,171 Airtec-SF 125 2022 Units 116,199 15,968 Airtec-SF 250 43,573 21,128 SFP Airtec-SF 2021 Units 46,993 20,782 12,453 17,066 5,703 Airtec-SF 125 2022 Units Airtec-SF 250 SFP Airtec-SF 2021 Units 43,468 Airtec-SF 125 2022 Units 99,133 3,515 Airtec-SF 250 Seroflo Competitor Landscape Antiasthma ICS Combination Market B/F SFP FFV Product 1: • Symbicort Product 1: • Seretide Product 1: • Relvar Ellipta Device Name: • Turbohaler Manufacturer: • AstraZeneca Doses: • 80 MCG/4.5 MCG (120 Device Name: • Discus (DPI), Evohaler (MDI) Manufacturer: • GSK Doses: • 250 MCG/50 MCG (60 Puff) Device Name: • Ellipta Manufacturer: • GSK Doses: • 100 MCG/25 MCG (30 Puff) (116.70 SAR) • 160 MCG/ 4.5 MCG (120 Puff) (169.80 SAR) Product 2: • Bufomix Device Name: • Easyhaler Manufacturer: • Al Hikma Doses: • 160 MCG/ 4.5 MCG (120 Puff) (122.7 SAR) (126.45 SAR) • 500 MCG/50 MCG (60 Puff) (166.75 SAR) • 125 MCG/25 MCG (120 • Puff) (112.80 SAR) 250 MCG/25 MCG (120 Puff) (148.85 SAR) Product 2: • Airtec-SF (Combiwave) Device Name: • Inhaler (MDI) Manufacturer: • Glenmark Doses: • 125 MCG/25 MCG (120 Puff) (44.5 SAR) • 250 MCG/25 MCG (120 Puff) (64.4 SAR) Puff) (158.4 SAR) • 200 MCG/25 MCG (30 Puff) (158.4 SAR) FFP Product 1: • Flutiform Device Name: • K-Haler Manufacturer: • Mondi Doses: • 125 MCG/5 MCG (120 Puff) (130 SAR) • 250 MCG/10 MCG (120 Puff) (225 SAR) AACs briefed Comparison Molecu Symbicort le LABA ICS Seretide Bufomix Combiwave Formoterol (is a long-acting β2 agonist) which is used as bronchodilator. Inhaled formoterol works like other β2 agonists, causing bronchodilation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma. Formoterol is classified as fast acting bronchodilator. The main problem is that duration of action is only 7 hours which must be used more than twice/day. The protein binding of Formoterol is 67% which lead to systemic side effects + the selectivity of Formoterol is lower than salmeterol which increase the side effects of Formoterol such as tremors and palpitations. The maximum dose/day 24mcg. Salmeterol (is a long-acting β2 agonist) which is used as bronchodilator. These drugs stimulate beta-2 receptors present in the bronchial musculature. This causes them to relax and prevent the onset and worsening of symptoms of asthma. The main power of Salmeterol is the duration of action is for 12 hours. Also have protein binding of 96% which make it mare selective and lower in systemic side effect than other molecules. The maximum dose/day 100mcg. Formoterol (is a long-acting β2 agonist) which is used as bronchodilator. Inhaled formoterol works like other β2 agonists, causing bronchodilation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma. Formoterol is classified as fast acting bronchodilator. The main problem is that duration of action is only 7 hours which must be used more than twice/day. The protein binding of Formoterol is 67% which lead to systemic side effects + the selectivity of Formoterol is lower than salmeterol which increase the side effects of Formoterol such as tremors and palpitations. Formoterol (is a long-acting β2 agonist) which is used as bronchodilator. Inhaled formoterol works like other β2 agonists, causing bronchodilation by relaxing the smooth muscle in the airway so as to treat the exacerbation of asthma. Formoterol is classified as fast acting bronchodilator. The main problem is that duration of action is only 7 hours which must be used more than twice/day. The protein binding of Formoterol is 67% which lead to systemic side effects + the selectivity of Formoterol is lower than salmeterol which increase the side effects of Formoterol such as tremors and palpitations. Budesonide is a synthetic pregnane steroid and non-halogenated cyclic ketal corticosteroid. It is a derivative of prednisolone, a hormone that reduces inflammation. Budesonide belongs to a class of medications called corticosteroids. Budesonide is an effective inhaled corticosteroid but less potent and less effective vs fluticasone propionate, and more effective than beclomethasone. The maximum dose/day 160mcg twice a day which will not cover the all day with formoterol dosing. Fluticasone propionate is a glucocorticoid used to treat asthma, inflammatory pruritic dermatoses, and nonallergic rhinitis. Fluticasone propionate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. Fluticasone is one of the most effective ICS molecules which is more potent than budesonide at the same dose and at least same effect at lower dose. The maximum dose/day: • MDI: 880mcg twice/day • DPI: 1000mcg twice/day According to goal and concept studied SFP is achieving the total control definition acc. To GINA guideline vs B/F. Discus: Evohaler: • Portable • Portable Fluticasone propionate is a glucocorticoid used to treat asthma, inflammatory pruritic dermatoses, and nonallergic rhinitis. Fluticasone propionate works through an unknown mechanism to affect the action of various cell types and mediators of inflammation. Fluticasone is one of the most effective ICS molecules which is more potent than budesonide at the same dose and at least same effect at lower dose. The maximum dose/day: • MDI: 880mcg twice/day According to goal and concept studied SFP is achieving the total control definition acc. To GINA guideline vs B/F. Budesonide is a synthetic pregnane steroid and nonhalogenated cyclic ketal corticosteroid. It is a derivative of prednisolone, a hormone that reduces inflammation. Budesonide belongs to a class of medications called corticosteroids. Budesonide is an effective inhaled corticosteroid but less potent and less effective vs fluticasone propionate, and more effective than beclomethasone. The maximum dose/day 160mcg twice a day which will not cover the all day with formoterol dosing. Easyhaler: • Portable Inhaler • Portable Turbohaler: • Portable Seroflo Marketing Messages Seroflo (Live-asthma without asthma) For Adult patients with For Adult patients with Asthma using ICS only Asthma using ICS combination (BUD/FOR) Goal Study Goal Study 31% 63% Achieved the total control vs 19% only with ICS only 72% Achieving Symptom free days over 1 year vs 52% only with ICS 58% Achieved the well control GINA definition vs 50% only with ICS only Of the patient have improved lung function over 1 year vs 17% only with ICS only Concept Study 58.8% Increase in symptoms free day vs 52.2% with BUD/FOR 48% Fewer exacerbatio n rate than BUD/FOR Concept Study 90.5% achieved days free of rescue medication vs 85.6% only with BUD/FOR 82.7 % Achieve the well control vs 71.2% only with BUD/FOR Seroflo– Available Devices & Dose MDI (Inhaler) DPI (Ciphaler) 100 250 500 Take Hom e Take Hom e 100mcg Twice a 50mcg Salmeterol Fluticasone day 85.10 250mcg SAR a Twice 50mcg Salmeterol Fluticasone day 113.80 500mcg Twice a 50mcg Salmeterol SAR Fluticasone day 158.40 Rinse your mouth after SAR each use Ensure the correct use of devices 125 125mcg Fluticasone 25mcg Salmeterol 250 250mcg Fluticasone 25mcg Salmeterol Two Puffs Twice a day 99.55 SAR Two Puffs Twice a day 131.35 SAR Thank You