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The Label Challenge • The FDA wants to differentiate the tamper-resistant opioids to encourage prescribing over the standard formulations, but does not want to allow these products to be promoted as abuseresistant opioids. • A false sense of security may lead to lax prescribing (and diversion) problems, particularly with primary care physicians. Alpharma FDA Advisory Committee Briefing Package © Defined Health, 2009 Pain Insight Briefing 54
The Real Issue is Risk Management • Risk management plan negotiations are likely to delay approval of both Embeda/ALO-01 and Remoxy. • There is concern over REMS (Risk Evaluation & Mitigation Strategy) plans to encourage physician education and prevent over-prescribing. • The FDA will require King and Alpharma to rigorously monitor postmarketing use of their products in order to gauge abuse levels. This is in the context of: • Significant challenges of abuse monitoring, • Flaws with the tools currently available. • The likely data focus will be adverse events databases and hospitalization statistics. • “Street value” may also be considered as a measure of abusability. • These data ultimately may lead to stronger tamper-resistance labeling and perhaps even an abuse-resistance claim, but the prediction was that such claims are unlikely to be granted for at least 2-3 years post-launch. Alpharma FDA Advisory Committee Briefing Package © Defined Health, 2009 Pain Insight Briefing 55
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 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: The Technologies are Not the Proble
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
Page 93 and 94: Repurposed anti-TNF Antibodies for
Page 95 and 96: What’s Next for Pain? • Continu
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