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TRPV Agonists: NeurogesX Capsaicin Patch NGX-4010: 8% w/w capsaicin (capsaicin 640 mcg/cm2) patch optimized for rapid cutaneous delivery. 84 Treatment procedure (in office, physician supervised): • Identify painful area • Apply topical anes<strong>the</strong>tic • Cut NGX-4010 to conform to painful area • Apply NGX-4010 for 30 to 60 minutes • Remove NGX-4010, clean area with Cleansing Gel Company website © Defined Health, 2009 Pain Insight Briefing
Good Phase III Data, An Accepted NDA … But No Commercial Partner December 19, 2008: NeurogesX Announces FDA Acceptance to Review New Drug Application for NGX-4010 to Treat Post-Herpetic Neuralgia Backonja M, et al. Presented at <strong>the</strong> American Academy of Neurology 60th Annual Meeting, Chicago; April 2008 85 © Defined Health, 2009 Pain Insight Briefing Primary endpoint (% reduction from baseline during Weeks 2-8) •NGX-4010 −32% vs. Control −24% (p=0.011) •Consistent results over 3 months •32% average pain reduction during Weeks 2-12 (p=0.0172) •Responders (≥ 30% reduction) 46% responders (p=0.0196)
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Game Changing Plays in the Pain Mar
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Our Disclaimer 3 The information in
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Everyone Hurts “Pain is whatever
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It’s A Big Market with a Few Domi
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$ Millions But Few “Big Pharma-Si
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Pain Historically: Drug Delivery ha
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It’s Getting Tougher Labopharm La
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The Risk : Reward Profile for Novel
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Current Standard of Care for Pain
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Leaving Plenty of Unmet Need to Be
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In the Meantime, Let’s Teach Old
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A Better NSAID: NicOx • Naproxcin
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A Better NSAID: NicOx 25 Company pr
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A Better NSAID: Pozen / AstraZeneca
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The First-to-Market Topical NSAIDs
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Even So, Flector is Expected To Be
Page 33 and 34: Now We Have a Patch and a Gel Volta
Page 35 and 36: The Need is Clear 35 © Defined Hea
Page 37 and 38: Progenics / Wyeth: Making Opioids M
Page 39 and 40: Adolor / Pfizer: Making Opioids Mor
Page 41 and 42: Like All Things CNS, It’s Not So
Page 43 and 44: A New, and Better Opioid from J&J /
Page 45 and 46: A New, and Better Opioid from J&J /
Page 47 and 48: Opioid Abuse Deterrence 47 © Defin
Page 49 and 50: King Pharmaceuticals: Making Big Be
Page 51 and 52: But Also Significant Hurdles • Te
Page 53 and 54: The Technologies are Not the Proble
Page 55 and 56: The Real Issue is Risk Management
Page 57 and 58: Fentanyl: Again, REMS is the Big Re
Page 59 and 60: Lessons from Fentora 59 What the FD
Page 61 and 62: For Some Mechanisms, the US Regulat
Page 63 and 64: FAAH Pipeline 63 Compound SSR 10101
Page 65 and 66: FAAH Pipeline KDS-4103, acquired by
Page 67 and 68: Addressing the Big Problem 67 >50%
Page 69 and 70: New MOA Challenges 69 NeuroDiscover
Page 71 and 72: New MOA Challenges 71 The identific
Page 73 and 74: TRPV1 • The transient receptor po
Page 75 and 76: TRPV1: Target for Novel Analgesics
Page 77 and 78: TRPV1 Antagonists: Hot … Too Hot
Page 79 and 80: TRPV1 Antagonist Pipeline Compound
Page 81 and 82: TRPV1 Antagonist Pipeline 81 Compou
Page 83: TRPV3: Hopeful, But Too Early to Te
Page 87 and 88: Pfizer Pursuing Multiple Chronic Pa
Page 89 and 90: Concerning, but Transient Adverse E
Page 91 and 92: Will NGF for Pain Be Like TNF is fo
Page 93 and 94: Repurposed anti-TNF Antibodies for
Page 95 and 96: What’s Next for Pain? • Continu
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