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For Some Mechanisms, the US Regulatory Risk May be Too High 60 • Canada: – 2005 approval for neuropathic pain. – 2007 as adjunct analgesic in patients with advanced cancer who experience moderate to severe pain during the highest tolerated dose of strong opioid therapy for persistent background pain. • UK: available as prescription on a named patient basis; available on a compassionate access basis in the Catalonian region of Spain. • US: investigational drug (Phase II/III) being developed in partnership with Otsuka Pharmaceutical Co. as an adjunctive analgesic treatment for patients with advanced cancer whose persistent pain has not been adequately relieved by optimized treatment with strong opioids. The FDA has not approved Sativex and the product is not available in the US other than for use in FDA approved clinical trials. GW Pharmaceuticals presentation, Arrowhead Pain Therapeutics Summit 2008; Company website © Defined Health, 2009 Pain Insight Briefing
For Some Mechanisms, the US Regulatory Risk May be Too High 61 The Controlled Substances Act of 1970, which created the five schedule classification system for drugs, assigned marijuana a Schedule I designation. This classification puts marijuana alongside heroin and hallucinogens as a dangerous and addictive drug with no accepted medical use. Note: On July 13, 1986, the DEA issued a Final Rule and Statement of Policy authorizing the "Rescheduling of Synthetic Dronabinol (Synthetic/Extract THC) in Sesame Oil and Encapsulated in Soft Gelatin Capsules From Schedule I to Schedule II"(DEA 51 FR 17476-78). This permitted medical use of Marinol (Solvay), albeit with the severe restrictions associated with Schedule II status. Marinol is now Schedule III. www.usdoj.gov/dea/pubs/csa.html © Defined Health, 2009 Pain Insight Briefing
- 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 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: Lessons from Fentora 59 What the FD
- 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
For Some Mechanisms, <strong>the</strong> US Regulatory Risk<br />
May be Too High<br />
60<br />
• Canada:<br />
– 2005 approval for neuropathic pain.<br />
– 2007 as adjunct analgesic in patients with advanced cancer who experience moderate to<br />
severe pain during <strong>the</strong> highest tolerated dose of strong opioid <strong>the</strong>rapy for persistent<br />
background pain.<br />
• UK: available as prescription on a named patient basis; available on a compassionate access<br />
basis in <strong>the</strong> Catalonian region of Spain.<br />
• US: investigational drug (Phase II/III) being developed in partnership with Otsuka<br />
Pharmaceutical Co. as an adjunctive analgesic treatment for patients with advanced cancer<br />
whose persistent pain has not been adequately relieved by optimized treatment with strong<br />
opioids. The FDA has not approved Sativex and <strong>the</strong> product is not available in <strong>the</strong> US o<strong>the</strong>r<br />
than for use in FDA approved clinical trials.<br />
GW Pharmaceuticals <strong>presentation</strong>, Arrowhead Pain<br />
Therapeutics Summit 2008; Company website<br />
© Defined Health, 2009<br />
Pain Insight Briefing
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