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New MOA Challenges • Animal models are insufficiently representative of the multidimensional aspects of clinical pain. • Humans, however, are the species of relevance and volunteers are able to verbally communicate their experience of pain and pain relief in a way that is impossible with animals. • Patients can also be stratified into subgroups, to help develop more specific treatment strategies. For example, human studies are revealing gender differences in pain processing, and showing that painkillers appear to work differently in men and women. Neuroimage. 2008 Aug 15;42(2):467-73. Epub 2008 May 29. 72 © Defined Health, 2009 Pain Insight Briefing
TRPV1 • The transient receptor potential cation channel, subfamily V, member 1 also known as TRPV1 is a ligand-gated nonselective cation channel that may be activated by a wide variety of exogenous and endogenous physical and chemical stimuli, including heat greater than 43°C, low pH (acidic conditions), the endocannabinoid anandamide, N-arachidonoyl-dopamine, and capsaicin. • TRPV1 receptors are found in the central nervous system and the peripheral nervous system and are involved in the transmission and modulation of pain, as well as the integration of diverse painful stimuli. • TRPV1 blockade in vivo elicits hyperthermia in multiple species, from rodents to humans, suggesting that TRPV1 is involved in body temperature maintenance. 73 Nature Reviews Drug Discovery Vol.6 May 2007 © Defined Health, 2009 Pain Insight Briefing Homology model of the TRPV1 ion channel tetramer (where the monomers are individually colored cyan, green, blue, and magenta respective) imbedded in a cartoon representation of a lipid bilayer. PIP2 signaling ligands are represented by space-filling models (carbon = white, oxygen = red, phosphorous = orange).
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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
Page 21 and 22: In the Meantime, Let’s Teach Old
Page 23 and 24: A Better NSAID: NicOx • Naproxcin
Page 25 and 26: A Better NSAID: NicOx 25 Company pr
Page 27 and 28: A Better NSAID: Pozen / AstraZeneca
Page 29 and 30: The First-to-Market Topical NSAIDs
Page 31 and 32: 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: New MOA Challenges 71 The identific
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 and 84: TRPV3: Hopeful, But Too Early to Te
Page 85 and 86: Good Phase III Data, An Accepted ND
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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