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Like All Things CNS, It’s Not So Easy 42 F I N A L T R A N S C R I P T To close the Delta section of this call, it is our interpretation that the results of these preliminary Phase IIa trials of Dec. 18. 2008 / 8:30AM, ADLR - Adolor Corporation Investor Update Call Just completed two Phase IIa trials on ADL5859 to explore safety and efficacy in two distinct models of pain: diabetic ADL5859 peripheral neuropathy were inconclusive as a model of neuropathic as to pain; and rheumatoid arthritis as a model of chronic inflammatory pain. Neither showed statistical significance efficacy. on efficacy Pfizer measures, and we but were continue safe and well to tolerated. The company is now evaluating the current formulation and considering an increase in exposure and decrease in variability before initiating additional studies in patients. believe that Delta Agonists represent an exciting new class of drugs to treat pain and are in agreement that both ADL5859 For ADL5747, our second Delta Agonist, we recently have completed enrollment in a multiple ascending dose Phase and I trial ADL5747 in 32 healthy merit volunteers. continued To date, we clinical have not observed any dose-limiting toxicity development. or clinically significant adverse events. Pfizer and we intend to initiate a proof of concept trial of 5747 in osteoarthritis during the third quarter of 2009 and in neuropathic pain in the fourth quarter of 2009. To close the Delta section of this call, it is our interpretation that the results of these preliminary Phase IIa trials of ADL5859 were inconclusive as to efficacy. Pfizer and we continue to believe that Delta Agonists represent an exciting new class of drugs to treat pain and are in agreement that both ADL5859 and ADL5747 merit continued clinical development. © Defined Health, 2009 Pain Insight Briefing
A New, and Better Opioid from J&J / Grunenthal 43 Tapentadol IR dosing non-inferior to oxycodone IR in terms of efficacy with lower incidence of nausea, vomiting and constipation. The Journal of Pain, Volume 9, Issue 4, Supplement 1, April 2008, Page 32 M. Afilalo, C. Oh, A. Okamoto, I. Van Hove, J. Stegmann, D. Upmalis © 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 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: Like All Things CNS, It’s Not So
- 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 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
A New, and Better Opioid from J&J / Grunenthal<br />
43<br />
Tapentadol IR<br />
dosing non-inferior<br />
to oxycodone IR in<br />
terms of efficacy<br />
with lower incidence<br />
of nausea, vomiting<br />
and constipation.<br />
The Journal of Pain, Volume 9, Issue 4, Supplement 1, April 2008, Page 32<br />
M. Afilalo, C. Oh, A. Okamoto, I. Van Hove, J. Stegmann, D. Upmalis<br />
© Defined Health, 2009<br />
Pain Insight Briefing
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