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A Better NSAID 22 Constipation, sedation, confusion, respiratory depression, mental clouding, renal colic, tolerance to prolonged use and risk of abuse, misuse, addiction. Gastrointestinal ulcers, stomach bleeding, Celebrex tinnitus (Pfizer) PN400 (Nexium/naproxen), AstraZeneca/Pozen Naproxcinod (NicOx) Topical NSAIDs Gastric erosion, peptic ulcer, inflammation of the duodenum and of the colon, renal toxicity with prolonged use Step 1: Mild Pain (1-3/10) • Aspirin (ASA) • Acetaminophen (APAP) • Nonsteroidal anti-inflammatory drugs (NSAIDs) • +/- Adjuvants World Health Organization © Defined Health, 2009 Pain Insight Briefing Step 2: Moderate Pain (4-6/10) • APAP or ASA + – Codeine – Hydrocodone – Oxycodone – Dihydrocodeine – Tramadol (not available with APAP or ASA) – +/- Adjuvants Step 3: Severe Pain (7-10/10) • Morphine • Hydromorphone • Methadone • Levorphanol • Fentanyl • Oxycodone • +- Nonopiod analgesics • +/-Adjuvants •Adjuvant Therapy: – Anticonvulsants – Antidepressants – Corticosteroids – Dermal analgesics – Muscle relaxants – Stimulants
A Better NSAID: NicOx • Naproxcinod is a derivative of naproxen with similar anti-inflammatory activity, but less gastrointestinal side effects. It is the first of a new class of analgesic and antiinflammatory drugs known as cyclo-oxygenase-(COX)-inhibiting nitric oxide donators (CINODs). • The improved gastrointestinal tolerability of naproxcinod appears to be due to its release of nitric oxide (NO) and the consequent maintenance of tissue perfusion and integrity. Data to date also suggests that naproxinod may also have a beneficial and sustained impact on blood pressure. • Naproxcinod is in Phase III clinical development in Europe, the US and Canada for the treatment of osteoarthritis. NDA filing is projected for mid-2009. Adis R&D Insight; NicOx presentation 23 © Defined Health, 2009 Pain Insight Briefing
Page 1 and 2: Game Changing Plays in the Pain Mar
Page 3 and 4: Our Disclaimer 3 The information in
Page 5 and 6: Everyone Hurts “Pain is whatever
Page 7 and 8: It’s A Big Market with a Few Domi
Page 9 and 10: $ Millions But Few “Big Pharma-Si
Page 11 and 12: Pain Historically: Drug Delivery ha
Page 13 and 14: It’s Getting Tougher Labopharm La
Page 15 and 16: The Risk : Reward Profile for Novel
Page 17 and 18: Current Standard of Care for Pain
Page 19 and 20: Leaving Plenty of Unmet Need to Be
Page 21: In the Meantime, Let’s Teach Old
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 and 72: New MOA Challenges 71 The identific
Page 73 and 74:
TRPV1 • The transient receptor po
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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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