Access Pharma/SpePharm- MuGard

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Access Pharmaceuticals' presentation on MuGard. It has been found recently in tests that Mugard is a great preventative for oral mucositis, a debilitating side effect of many patients that undergo radiation and chemo therapy.

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Access Pharma/SpePharm- MuGard

  1. 1. Prescribing information is available at this meeting<br />
  2. 2. <ul><li>Mean incidence of mucositis is 80%1
  3. 3. Over 90% of patients receiving radiotherapy will develop some degree of oral mucositis (OM)1
  4. 4. Up to 43% will present with severe oral mucositis1
  5. 5. Up to 40% of patients receiving chemotherapy will develop OM2</li></ul>Mucositis is a significant health issue in patients receivingradiotherapy/chemotherapy<br />The severity of oral mucositis varies with type of chemotherapy, radiationdose and schedule<br />Trotti, A., L. A. Bellm, et al. (2003). &quot;Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review.&quot; Radiother Oncol 66(3): 253-62<br />Karthaus, M., C. Rosenthal, et al. (1999). &quot;Prophylaxis and treatment of chemo- and radiotherapy-induced oral mucositis - are there new strategies?&quot; Bone Marrow Transplant 24(10): 1095-108.<br />Prescribing information is available at this meeting<br />
  6. 6. Signs and<br />symptoms<br />include1<br />Erythema<br />Ulceration<br />Pain –sometimes severe<br />Inability tochew, swallow or speak<br />Patient risk affected by1<br />Chemotherapy<br />intensity of treatmentconcurrent radiationmethotrexate<br />Radiation<br />target areatotal dosetreatment time<br />Poor dentition<br />ill fitting prosthetic appliances<br />dentures<br />sharp or fractured teeth<br />BMI - extremely low or high<br />Medication related poor salivary gland function<br />Prior episode of mucositis<br />Schattner MD. Oral mucositis is often underrecognized and undertreated. Highlights of the 13th Annual Conference National Comprehensive Cancer Network. March 2008. Elsevier.Downloaded from www.nccn.org Dec 2000<br />Prescribing information is available at this meeting<br />Mucositis is a significant health issue in patients receivingradiotherapy/chemotherapy<br />
  7. 7. Oral mucositis - has a profound impact on patient’s health<br />“…patients with OM [oral mucositis] are fourfold more likely to have unplanned breaks in radiation therapy and more than three timesas likely to be hospitalized…”1<br />International guidelines recommend preventive strategies2<br />“Use of a preventive oral care regimen should be part of routine supportive care along with a therapeutic oral care regimen if mucositis develops”2<br />Vera-Llonch, M., G. Oster, et al. (2006). &quot;Oral mucositis in patients undergoing radiation treatment for head and neck carcinoma.&quot; Cancer 106(2): 329-36<br />Keefe, D. M., M. M. Schubert, et al. (2007). &quot;Updated clinical practice guidelines for the prevention and treatment of mucositis.&quot; Cancer 109(5): 820-31.<br />Prescribing information is available at this meeting<br />
  8. 8. Introducing MuGard<br />MuGard is an innovative mucoadhesive oral rinse which forms a protective hydrogel coating over the oral mucosa1<br />MuGard is indicated for the prevention and management of the lesions and symptoms of oral mucositis1<br />MuGard is the first ready-to-use mouth rinse<br />Carbomerhomopolymer A, <br />polysorbate 60,<br />glycerin, benzyl<br />alcohol, citric acid,<br />sodium saccharin,<br />potassium hydroxyde,<br />phosphoric acid,<br />purified water<br />Viscous ready-to-use liquid, supplied in 250ml glass bottle<br />MuGard Instructions for Use.<br />Prescribing information is available at this meeting<br />
  9. 9. Mucositis Severity - Patient Analysis<br />Start MuGard when you start therapy<br />42% of MuGardgroup did notdevelopsignificantmucositiscompared withonly 7% in thecontrol group1<br />80%<br />70%<br />MuGard<br />Standard Care<br />60%<br />50%<br />40%<br />30%<br />20%<br />10%<br />0%<br />None<br />Mild<br />Moderate<br />Severe<br />OMAS score range2<br />≤ 0.56<br />0.56 and ≤ 0.78<br />&gt; 0.78 and ≤ 1.11<br />&gt; 1.11<br />Baud CM, Colon LE, Gerberich J, Nowotnik DP, Howell SB Protection from Radiation-Induced Oral Mucositis by MuGard™ Oral Rinse - A Clinical Study and in silico Analysis. Poster at The 18th International Symposium of the Multinational Association of Supportive Care in Cancer in Toronto, June 22-24, 2006.<br />Sonis et al. Validation of a New Scoring System for the Assessment of Clinical Trial Research of Oral Mucositis Induced by Radiation or Chemotherapy. Cancer; 1999;85:2103-2113<br />Prescribing information is available at this meeting<br />
  10. 10. MuGard significantly reduces the severity of oral mucositis<br />2.0<br />1.8<br />1.6<br />1.4<br />1.2<br />1.0<br />0.8<br />0.6<br />0.4<br />0.2<br />0<br />OMAS vs. Time - Dataset 2<br />Mean + SEM<br />Mean mucositisscores lower forpatients usingMuGard than forsimilar patients onstandard care1<br />Standard Care<br />MuGard<br />15<br />17<br />11<br />13<br />9<br />5<br />7<br />1<br />3<br />Oral Mucositis Assessment Scale (OMAS)2<br />Ulceration 0 = no lesion 1 = &lt; 1 cm2 2 = 1 cm2 – 3 cm2 3 = &gt; 3 cm2<br />Erythema 0 = none 1 = not severe 2 = severe<br />Baud CM, Colon LE, Gerberich J, Nowotnik DP, Howell SB Protection from Radiation-Induced Oral Mucositis by MuGard™ Oral Rinse - A Clinical Study and in silico Analysis. Poster at The 18th International Symposium of the Multinational Association of Supportive Care in Cancer in Toronto, June 22-24, 2006.<br />Sonis et al. Validation of a New Scoring System for the Assessment of Clinical Trial Research of Oral Mucositis Induced by Radiation or Chemotherapy. Cancer; 1999;85:2103-2113<br />Prescribing information is available at this meeting<br />
  11. 11. Easy to manage, easy to take<br />Because MuGard does not include any active pharmacological agent, there are no known adverse interactions with medicinal or other products<br />No undesirable side-effects have been reported to date<br /><ul><li>No safety issues have been reported if swallowed
  12. 12. No case of overdose has been reported </li></ul>Treatment should be initiated at the beginning of radiation therapy or chemotherapy, even before the signs and symptoms of mucositis are evident<br />Prescribing information is available at this meeting<br />
  13. 13. Prescribing information is available at this meeting<br />Easy to manage, easy to take<br />
  14. 14. Start MuGard when you start therapy<br />Mucositis is a common complication of cancer chemotherapy and radiotherapy and compromises patient’s well being and treatment1<br />MuGard is a preventive approach in line with international guidelines2<br /><ul><li>42% of MuGard group did not develop significant mucositis compared with only7% in the control group3
  15. 15. Mean mucositis scores lower for patients using MuGard than for standard care3</li></ul>MuGard has no known adverse interactions with medicinal or other products4<br />MuGard is the first ready-to-use mouth rinse<br />Rubenstein, E. B., D. E. Peterson, et al. (2004). &quot;Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis.&quot; Cancer 100(9 Suppl): 2026-46.<br />Keefe, D. M., M. M. Schubert, et al. (2007). &quot;Updated clinical practice guidelines for the prevention and treatment of mucositis.&quot; Cancer 109(5): 820-31.<br />Baud CM, Colon LE, Gerberich J, Nowotnik DP, Howell SB (2006)Protection from Radiation-Induced Oral Mucositis by MuGard™ Oral Rinse - A Clinical Study and in silico Analysis.Poster at The 18th International Symposium of the Multinational Association of Supportive Care in Cancer in Toronto, June 22-24, 2006.<br />MuGard Instructions for Use.<br />Prescribing information is available at this meeting<br />

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