Topcial Therapies Reviewed- Chad Robertson - CSTS- March 2011

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Topcial Therapies Reviewed- Chad Robertson - CSTS- March 2011

  1. 1. © 2011 Zanagen Limited Education Chad Robertson B.Sc. (Kin) B.Sc. (Pharm) Zanagen Limited maintains ownership of all content and/or images contained in this presentation
  2. 2. Learning Objectives <ul><li>Session I: Background </li></ul><ul><ul><li>Benefits of Topical Therapy for the Management of Pain and Connective Tissue Disorders </li></ul></ul><ul><ul><li>Old and New Concept “Pain Models” </li></ul></ul><ul><ul><li>Acute and Chronic Pain Conditions </li></ul></ul><ul><li>Session 2: Treating Pain from the Outside </li></ul><ul><ul><li>History of Transdermal Therapy </li></ul></ul><ul><ul><li>Evolving Transdermal Products </li></ul></ul><ul><ul><li>Strategies for Optimizing Skin Penetration </li></ul></ul><ul><ul><li>Key Points to Consider when Recommending Topical Therapy </li></ul></ul>
  3. 3. In the News – Drug Recalls <ul><li>Popular Arthritis Drug May Disrupt </li></ul><ul><li>Heart Rhythms </li></ul><ul><li>Science Daily – Celebrex, a popular </li></ul><ul><li>arthritis drug that blocks pain by </li></ul><ul><li>inhibiting the enzyme COX-2, has </li></ul><ul><li>been shown in laboratory studies to </li></ul><ul><li>induce arrhythmia, or irregular </li></ul><ul><li>beating of the heart, via a novel </li></ul><ul><li>pathway unrelated to its COX-2 </li></ul><ul><li>inhibition. Pfizer manufacturers </li></ul><ul><li>Celebrex and in 2004 sales were </li></ul><ul><li>$3.3 Billion Worldwide. </li></ul>
  4. 4. In the News – Drug Recalls <ul><li>Vioxx Side-Effects: Possible </li></ul><ul><li>Explanation </li></ul><ul><li>Science Daily 2007 – Vioxx and </li></ul><ul><li>related pain medications were taken </li></ul><ul><li>off the market in 2004 because they </li></ul><ul><li>caused dangerous heart conditions in </li></ul><ul><li>some people. A group of scientists, </li></ul><ul><li>led by Timothy Hla at the University of </li></ul><ul><li>Connecticut, may now have figured </li></ul><ul><li>out how these drugs trigger life </li></ul><ul><li>threatening side-effects. </li></ul>
  5. 5. In the News – Drug Recalls <ul><li>Bextra Recall and Withdrawal News </li></ul><ul><li>ScienceDaily – Health Canada asked </li></ul><ul><li>Pfizer to immediately suspend sales </li></ul><ul><li>of its drug after the drugmaker has </li></ul><ul><li>been forced to remove Bextra from </li></ul><ul><li>the U.S. and European markets. The </li></ul><ul><li>manufacturer continued to stand </li></ul><ul><li>behind the safety of the drug in spite </li></ul><ul><li>of adding a warning in October 2004 </li></ul><ul><li>that the drug increased the </li></ul><ul><li>occurrence of heart problems in high </li></ul><ul><li>risk patients </li></ul>
  6. 6. What If? <ul><li>You could avoid taking pills for acute & chronic pain </li></ul><ul><li>There was an all natural pain relief solution that worked </li></ul><ul><li>You could avoid side effects such as; gastritis, dizziness, cardio vascular, liver & kidney related issues </li></ul><ul><li>You were able to control your acute and chronic pain easily </li></ul><ul><li>You could possibly deactivate the enzyme that converts acute </li></ul><ul><li>Pain to chronic pain prior to chronic pain setting in </li></ul>
  7. 7. Why Topical Creams – Why Now? <ul><li>Pain relief pharmaceuticals** are being taken off the market by the FDA & Health Canada due to severe side effects – eg. </li></ul><ul><li>NSAID’s*: Vioxx, Bextra & Prexige (and possibly Celebrex) </li></ul><ul><li>Consumers excessive reliance on oral medication (pills) </li></ul><ul><li>An aging population with higher incidences of chronic pain </li></ul><ul><li>Escalating worldwide health care costs </li></ul><ul><li>Prescription drugs abuse and misuse </li></ul><ul><li>* NSAID – Non-Steroidal Anti-Inflammatory Drug </li></ul><ul><li>** Nutraceuticals are natural food components that provide health benefits or reduce the risk of chronic disease </li></ul>
  8. 8. Trandermal Delivery Has Expansion Potential <ul><li>Acts Quicker than Ingestibles </li></ul><ul><li>Maintains Efficacy of Active Molecules </li></ul><ul><li>Diffusion through the skin avoids internal organs </li></ul><ul><li>Reduces potential side effects such as gastritis, dizziness, cardiovascular, liver & renal related issues </li></ul><ul><li>Avoid interaction of active molecules in the formulation with food and liquids </li></ul><ul><li>Less frequent application </li></ul><ul><li>Time saved & personal control over administration </li></ul><ul><li>Ease of removal to terminate therapy </li></ul><ul><li>Controlled release property </li></ul>
  9. 11. Classical Theory of Pain
  10. 15. Trandermal Rubs Have Not Changed in 100 Years <ul><li>Dr Bengué created Bengay in France in the 1890’s </li></ul><ul><li>He used Menthol’s palliative qualities to help manage pain topically </li></ul><ul><li>Fundamentally all current mass products use the same ingredients and have the same drawbacks </li></ul><ul><ul><li>The Menthol burn feels unpleasant </li></ul></ul><ul><ul><li>Menthol cannot be used everywhere on the body </li></ul></ul>
  11. 16. Evolving Transdermal Therapies <ul><li>Alternative natural-based topical therapies are emerging in the market </li></ul><ul><li>Focusing on targeting inflammatory and pain pathways in the body </li></ul><ul><li>Incorporating transdermal vehicles to enhance the absorption of active ingredients </li></ul><ul><li>Livrelief </li></ul><ul><ul><li>Distributed by LivDerma Inc. </li></ul></ul><ul><ul><li>Claim “blocks 5 pain pathways” </li></ul></ul><ul><ul><li>All natural ingredients </li></ul></ul><ul><li>Traumeel </li></ul><ul><ul><li>Distributed by Heel </li></ul></ul><ul><ul><li>Excessive dilution of homeopathic ingredients </li></ul></ul><ul><ul><li>Poor Clinical Testing Guidelines </li></ul></ul>
  12. 17. Evolving Transdermal Therapies <ul><li>Multiple mechanisms of action </li></ul><ul><li>Targets a variety of biochemical pathways: </li></ul><ul><ul><li>Inflammation </li></ul></ul><ul><ul><li>Regeneration </li></ul></ul><ul><ul><li>Remodeling </li></ul></ul><ul><ul><li>Incorporates penetration enhancers to improve absorption </li></ul></ul><ul><ul><li>Clinically Tested </li></ul></ul>
  13. 18. Prescription Based Transdermal Therapies <ul><li>Pennsaid </li></ul><ul><li>Prescription Topical </li></ul><ul><li>Launched in 2003 </li></ul><ul><li>Contains 1.50% w/w diclofenac sodium; 16mg/ml </li></ul><ul><li>Indicated for OA of the knees only </li></ul><ul><li>Contains DMSO (dimethyl sulfoxide) as a penetration enhancer </li></ul><ul><li>40 drops, four times per day </li></ul><ul><li>Incidence of local side-effects is high </li></ul>
  14. 19. Other Palliatives Have Emerged as an Alternative <ul><li>Alternatives are emerging as wraps and patches </li></ul><ul><li>Avoiding menthol, but only use heat and cold </li></ul>
  15. 20. Penetration Enhancement Techniques
  16. 21. Factors to Consider When Recommending a Topical Analgesic <ul><li>Factors to Consider are: </li></ul><ul><li>Medical history, including possible allergies and medication history </li></ul><ul><li>Dosage form </li></ul><ul><li>Active ingredient </li></ul><ul><li>Ease of use </li></ul><ul><li>Odour of the product </li></ul><ul><li>Cost, and options available </li></ul>
  17. 22. <ul><li>Topical analgesics should only be applied on intact skin </li></ul><ul><li>The use of topical analgesics should be discontinued if patient complains of excessive redness or blistering of the skin </li></ul><ul><li>Patients should be advised not to use heating devices in conjunction with topical counter-irritants </li></ul><ul><li>Patient education, provide clear instructions, express empathy and believe in your patient </li></ul><ul><li>Encourage patients to seek medical care if pain worsens or persists after 7 days of self-treatment </li></ul>Factors to Consider When Recommending a Topical Analgesic
  18. 23. Thank you for your time and consideration Chad Robertson B.Sc. (Kin) B.Sc. (Pharm) © 2011 Zanagen Limited Education

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