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“Make the World a Be/er Place”
Ensuring REMOXY Success
Confiden'al
Timothy R. Roe!82 Sherry Lane Kensington, CT 06037
(860) 829-6688 Home (860) 518-5571 Cell [email protected] Email www.m2details.com Web
Contents
Objec3ves and Limita3ons
About the Launch Background Informa3on
Compe33ve Look REMOXY In Vivo
Market Development and Projec3ons
Strategic Approach Research and Backup Slides
2 Confiden'al
3
6 9
23 33
44
47 61
Page
OBJECTIVES AND LIMITATIONS
3 Confiden'al
ObjecCves of PresentaCon
• Thorough understanding of the marketplace, REMOXY and the commercial environment
• Depict ability to think strategically
4 Confiden'al
LimitaCons
• Only publically available informa3on was u3lized
• Some data could not be adequately referenced, thus valida3on maybe suspect.
• Some public informa3on maybe dated or inaccurate.
• Conclusions or plans based on this work represents only one strategic direc3on and is without the benefit of team input (Marke3ng, Managed Markets, Tech Ops, Finance, Medical, Legal, Regulatory and Compliance, to name a few).
• Time – The deck is long. I will breeze through some parts that are well-‐understood. Some slides are incomplete but the thought process is present.
5 Confiden'al
ABOUT THE LAUNCH
Confiden'al
6
One Shot To Get It Right!! • The World is Watching…Wai3ng
• King absolutely needs this success
• Tireless pre-‐launch effort • Address Unmet Needs in Opioid-‐
based Pain Management
• Not an incremental step toward abuse-‐resistance – Must ensure percep3ons are managed consistently across all channels and targeted segments
7 Confiden'al
REMOXY “Making the World a Be1er Place”
I'm Gonna Make A Change,!For Once In My Life!
It's Gonna Feel Real Good,!Gonna Make A Difference!
Gonna Make It Right . . .!
…I'm Starting With The Man In!
The Mirror!I'm Asking Him To Change!
His Ways!And No Message Could
Have!Been Any Clearer!
If You Wanna Make The World!
A Better Place!(If You Wanna Make The!World A Better Place)!
Take A Look At Yourself, And!
Then Make A Change!
8 Confiden'al
BACKGROUND INFORMATION
9 Confiden'al
• Ini6al Terms – Big upfront – $150 million – Significant milestones – up to $150 million – Royal'es 15-‐20% – King to fund, but PTI to control development through Phase II, joint control through Phase III
• Complica6ons – PTI license to Durect Technology
• King to meet all PTI obliga'ons to Durect (due diligence, etc.)
– Ini'al Legal Hurdles • Limited to Durect technology applied to certain opioids • Possible compe''on from other Pain (non-‐Durect) products • Considered limited “Right of First Offer”
• CommercializaCon Due Diligence – Agreed on detailed ini3al budget for King – Couldn’t agree on detailed full budget at 3me of signing, so agreed on minimum and maximum level
of spending over several years with JDC to determine specifics
Source: Wilson Sonsini Goodrich & Rosa3 Post-‐Contract Presenta3on
(The Deal) /
10 Confiden'al
Source: PainBalance.org (Funded by and data provided by King Pharmaceu3cals)
• Up to 56 million American adults (28% of the adult popula3on) experience chronic pain. – 16 million experience low-‐back pain – 48 million have arthri3s—a disease
associated with chronic pain – 25 million have migraine pain – 20 million have jaw and lower-‐facial
pain – 4 million have neuropathic pain
• Many people have lived with pain for >5 years and experience it almost six days/week
• Younger people are as likely to experience chronic pain as are older people
• One-‐third of Americans lose 20 hours of sleep a month because of pain
Chronic Pain Prevalence
11 Confiden'al
Burden of Moderate-‐Severe Chronic Pain
• Total U.S. direct and indirect cost of chronic pain is between $50 & $90 billion per year – $4 billion of lost income and produc3vity, as well as healthcare costs, associated with arthri3s
pain – People with headache pain spend $4 billion on medica3ons according to a 2007 study
• Chronic pain is associated with millions of days of lost work – Chronic pain brings a burden of depression, anxiety, frustra3on, fa3gue, isola3on, and lowered
self-‐esteem. It shaoers produc3ve lives.
– “Presenteeism”: 75% of the lost Produc3vity is due to Reduced performance while on the job – not work absences.
– 25% of people in industrialized countries lose work because of chronic pain
– People with low-‐back pain lose 93 million days of work according to a 2007 study – People with headaches and migraine headaches lose 157 million days of work according to a 2007
study
• The American Board of Pain Medicine has taken the lead in educa3ng and creden3aling pain medicine specialists. – So far, the board has cer3fied just 1,700 doctors as pain specialists. That's about
one pain specialist for every 23,500 people who need care. – With specialists so rare, many pa3ents are cared for by doctors who lack training
and experience in the appropriate use of pain therapies.
Source: Chronic Pain Organiza3on Web Site May 7, 2010 Stewart, WF et al. JAMA, 2003;290:2443-‐2454 PainBalance.org (Funded by and data provided by King Pharmaceu3cals) 12
Confiden'al
Under-‐Treatment • Only 25% of those suffering from chronic pain receive
appropriate treatment – Postopera3ve, cancer, and chronic pain are unlikely to be treated
adequately – Elderly, children, minori3es, and substance abusers are unlikely to
receive adequate pain care – Doctor visits for pain-‐related illnesses were the primary reason for 66.16
million visits—7.3% of all visits—in the United States in 2003 – Drugs for the relief of pain were prescribed during all pa3ent visits more
oten than any other therapeu3c class
• Reasons for Under-‐treatment – Failure of healthcare professionals to properly assess pain – Pa3ent factors such as financial barriers and poor adherence – Mispercep3ons among healthcare professionals about the
consequences of opioid use – 40% of people with chronic non-‐cancer pain are not currently under a
healthcare professional’s care
• Many non-‐unified pain assessments and treatment algorithms
Source: PainBalance.org (Funded by and data provided by King Pharmaceu3cals)
13 Confiden'al
Percep3on
s
Supply
Physician
Needs Treatment
Major Barriers to NarcoCc Use • PaCent and Physician PercepCons
– Ease of abuse – Addic3on poten3al – Concern of stereotyping/s3gma
• Physician Issues (Opiophobia) – Rx matching, regulatory scru3ny – Abuse poten3al – Subop3mal knowledge of pain and poor
assessment tools – Fear of Robbery – PCPs manage 50% of all pa3ents with pain – Pa3ent non-‐compliance with script – 50% of pa3ents found it necessary to change
physicians, primarily because of inadequate pain management
– Oten relegated for terminally ill pa3ents leaving less supply for others
– Overdose with lethal consequences • The number of fatal poisonings involving opioid
analgesics more than tripled from 4,000 in 1999 to 13,800 in 2006, according to the Centers for Disease Control and Preven3on
• Supply Issues – FDA
• Stops several manufacturers from produc3on un3l passing modern approval process
• Under higher scru3ny ater Cox-‐2 Crisis – more stringent rules for new and safer drug op3ons
– Pharmacy Boolenecks • Blame distribu3on issues
– Distribu3on System • Security (Loss Preven3on & Training) • Refrigera3on requirements • Short-‐dated product • Manufacturer supply factors
• Cost and Coverage – Manufacturer Price/Rebate Structure – Independent Insurance/Payer Coverage,
Treatment Protocols & Guidance and Tier Structure
– Addi3ve cost for abuse and dependency treatments
– Diversion and Overseas Counterfei3ng
14 Confiden'al
FiZh Vital Sign
Research shows that when pa3ent’s acute pain is managed around the clock and the pain level is kept from becoming severe, the total amount of opioid needed is reduced.
15 Confiden'al
Pain is recognized as the “Fith Vital Sign” by the Joint Commission on Accredita3on of Healthcare Organiza3ons, the American Pain Society, and the Veterans Health Administra3on.
1. Body temperature 2. Pulse rate (or heart rate) 3. Blood pressure 4. Respiratory rate
5. Pain
Failure to Adequately Treat and Manage Chronic Pain
Confiden'al
16
PT with Unmanaged Chronic Pain
Seen by PCP or Specialists
Majority Treated Under Acute Pain Algorithms
Seen by PCP #2, 3… Due To Non-‐Relief
PT has difficulty func3oning produc3vely, misses work, develops secondary depression
Healthcare Costs Rise, MCO’s Restrict Access
Further
Modern Approach: Neurobehavioral Model
Most Chronic Pain cannot be treated like acute pain. It cannot be cured, it must be managed.
Chronic Pain Presenta3on PT
• Assessed • Ini3al Treatment • Managed
PCP/Spec
Pain Under Control for Long-‐Term PT
Gallagher, RM, Med Clin Noth Amer, 1999, 83 555-‐583; Gallagher, RM, AmJ Phys Med Rehab 2005, B4 (Suppl) s64-‐s76
Tradi3onal Approach:
In a 2008 APS study, nearly 50% of pa3ents found it necessary to change physicians at least twice, primarily because of inadequate pain management.
70% who received treatment con3nued to report pain.
Opioids: Advantages and Disadvantages
• Advantages – Effec3ve against moderate to severe pain,
par3cularly nocicep3ve pain
– No dose ceiling – No end-‐organ toxicity
• Disadvantages – Poten3ally addic3ve Class II controlled substances
• Pose risk of abuse, misuse, and diversion
– Dosage limita3ons due to side effects—especially cons3pa3on, nausea, and somnolence—may be necessary
– Can cause respiratory depression and should be used with cau3on in pa3ents with impaired ven3la3on
Source: PainBalance.org (Funded by and data provided by King Pharmaceu3cals)
17 Confiden'al
Confiden'al
18
American Society of Health-‐System Pharmacists (2009-‐03-‐23). "Oxycodone". U.S. Na3onal Library of Medicine, MedlinePlus. hop://www.nlm.nih.gov/medlineplus/druginfo/meds/a682132.html. Retrieved 2009-‐03-‐27.
Side Bar
Worldwide Produc3on Growth
11.5 tons in 1998 75.2 tons in 2007 (U.S. accounts for 82% or 51.6 tons in 2007)
That’s 3 trucks or 1 C-‐5 Galaxy
Side-‐Effects of Oxycodone IM
Common Opiate Methods of Abuse by Brand
19 Confiden'al
Source: Budman et al. Harm Reduc3on Journal 2009 6:8
REMOXY ADF
20 Confiden'al
Crushed
REMOXY
Crushed
OxyCon3n
No Rapid Release of Oxycodone Euphoria
REMOXY Design
• ORADUR Technology (SABER) – Gel cap sustained release – Novel, long-‐ac3ng formula3on – U3lizes a high-‐viscosity base for controlled release of ac3ve over 12 to 24 hour period
– Less prone to abuse – Manufactured by a simple process using conven3onal, scalable methods
– Lower CoGS than most compe33on yields higher profit margins
21 Confiden'al
REMOXY as a Recognized Name “Pre-‐CommercializaCon”
22 Confiden'al
COMPETITIVE LOOK Current and Horizon
Confiden'al
23
CompeCCon/OxyConCn Approval
24 Confiden'al
Approved: April 5, 2010
• The new formula3on will most likely result in less abuse by inhaling or injec3on, but it s3ll can be abused or misused by inges3ng larger doses than are recommended, the F.D.A. said.
• With the previous formula3on, those intent on abusing the drug could release high levels of oxycodone all at once by tampering with the pills.
• “Although this new formula3on of OxyCon3n may provide only an incremental advantage over the current version of the drug, it is s3ll a step in the right direc3on,” Bob Rappaport, the F.D.A.’s director of the Division of Anesthesia and Analgesia Products, said in a statement.
“Hillbilly Heroin”
REMOXY Needs a Respectable Piece of The Pie
Confiden'al
25
50M US Chronic Pain Sufferers
CompeCCve Oxycodone ERs in Development
Morphine in Phase II, Oxycodone in Phase I
26 Confiden'al
Confiden'al
27
CompeCCve Oxycodone ERs in Development
Egalet CompeCCve Deterrent
Confiden'al
28
Egalet Compared to Others Including REMOXY
Confiden'al
29
CompeCCve Oxycodone ERs in Development
INTELLITAB's delivery mechanisms maintain the controlled-‐release proper3es of a drug even if the tablet is broken, crushed or consumed with alcohol. Addi3onally if crushed and added to water, alcohol or other solvents, form a solid matrix that will prevent intravenous injec3on or insuffla3on (snor3ng).
Resists Typical Methods of Abuse: • When crushed or ground and taken orally, releases drug comparably to
an intact tablet, and significantly less than compe3ng technologies • When crushed or ground and snorted, releases significantly less drug
than an intact tablet, and significantly less than compe3ng technologies • When crushed or ground, cannot be injected • When placed in alcohol, will not dose dump
30 Confiden'al
Other ADFs
• OxyCon3n – oxycodone CR (Purdue) – Not permioed to market the tablet as tamper resistant. – New tablet will be marketed as a switch-‐out for the old tablet
"so both will not be sold,” there are no labeling changes. – Is marginal improvement so granted approval.
• Acurox – oxycodone IR (Acura/King) – “Among the weakest and most fundamentally flawed of the ADF
formula3ons currently in development.” – ADF defeated with 325mg Aspirin. Niacin flushing will simply
drive pa3ents to other physicians the Rx of a non ADF IR agent. – Could get “Tamper Resistant” label resul3ng in a marginal
improvement and be approved – Will add several years to development 3meline. Company only
has $33 million cash.
31 Confiden'al
Other ADFs • Embeda – (King) • COL-‐003 & COL-‐172 – DETERx Technology (Collegium)
• ATLP-‐0001 – Smart/Script (Atlan3c)
• OxyTrex (PTI) • Rexista (IntelliPharm)
32 Confiden'al
Watch for Transdermal Opioids
• Delay in onset of plasma levels
• Appears to be efficient route for chronic pain condi3ons (Small Compound Molecule)
• Examples • Fentanyl (Duragesic, IonSys) • Sufentanil (Endo, In Development) • Buprenorphine (Europe, Australia) • Hydromorphone (Altea, In development)
Confiden'al
33
Source: Pamela P. Palmer, MD Professor and Director, UCSF PainCARE Chief Medical Officer, AcelRx Pharmaceu3cals, Inc.
REMOXY IN VIVO
Confiden'al
34
REMOXY IN VIVO RESULTS
Four robust in vivo studies have shown that under certain physical and chemical challenges the controlled-‐release formula'on of REMOXY is not defeated and that these challenges do not result in a rapid release or dose dumping of oxycodone.
Moreover, a[er mechanical and/or chemical manipula'on, the rate of rise of oxycodone plasma concentra'ons from REMOXY is less and the Tmax is longer than a[er an oral oxycodone solu'on or OxyCon'n. The a]rac'on of drugs such as oxycodone for abuse purposes requires an effect that is both rapid and intense.
The Abuse Quo'ent (AQ), a measure of a]rac'veness of a formula'on for abuse, for REMOXY a[er physical and/or mechanical manipula'on remained far below that of OxyCon'n when manipulated in a similar manner, or a[er an immediate release oral solu'on of oxycodone. The5 4 3 2 1 0REMOXY +4% EtOH : REMOXY + Water REMOXY + 20% EtOH : REMOXY + Water REMOXY + 40% EtOH : REMOXY + Water0 10 20 30 Subject57 of 60Cmax Ra'oNDA 22-‐324 -‐ REMOXY® Advisory Commi]ee BriefingAvailable for Public Releasecombined data from these studies suggest that REMOXY a[er certain physical and chemical challenges may offer less appeal for abuse than its comparators.
35 Confiden'al
Summary
(Detailed Slides in Backup Sec3on)
REMOXY – Efficacy Success in Phase III Trial
Confiden'al
36
REMOXY – Efficacy Success in Phase III Trial
Confiden'al
37
REMOXY: AnC-‐Abuse Crushing Results
Confiden'al
38
(N = 10)
REMOXY Pivotal Phase III Study Design
Confiden'al
39
REMOXY In Vivo Results 1
• PTI-‐821-‐CZ – The controlled-‐release mechanism of the formula3on was not defeated ater crushing and extrac3ng with 40% ethanol.
– Tmax for REMOXY ater tamper was significantly greater than and twice as long as that of OxyCon3n. Cmax
– Although the rate of absorp3on was increased ater tamper, it remained well below that of OxyCon3n and for the comparator immediate release solu3on.
40 Confiden'al
REMOXY In Vivo Results 2
• PTI-‐821-‐C04 – Early Exposure (AUC) to oxycodone ater chewing REMOXY was much
lower than ater an oral solu3on, suppor3ng the premise that the controlled release formula3on was maintained.
– A decrease in Tmax and an increase in Cmax were observed ater rigorous chewing of REMOXY. However, the data indicated that the controlled-‐release mechanism of the REMOXY formula3on was not defeated, as was evident from the lack of dose dumping and plasma concentra3on profiles which retained a broad plateau, from a Tmax which remained approximately 2.5-‐fold longer than ater an oral oxycodone solu3on, and a Cmax which was lower than ater an oral solu3on.
– The data taken together demonstrate that although mas3ca3on of REMOXY does increase the rate of absorp3on of oxycodone and peak exposure compared to REMOXY swallowed whole, it does not approach that observed with an immediate release oxycodone oral solu3on.
41 Confiden'al
REMOXY In Vivo Results 3
• PTI-‐821-‐CU – Results from this study show that buccal administra3on of REMOXY resulted in an increase in the rate of oxycodone exposure, but one that was much lower than ater an oxycodone oral solu3on.
42 Confiden'al
REMOXY In Vivo Results 4
• PTI-‐821-‐CS – Ater co-‐inges3on of REMOXY with ethanol from 4-‐40% the plasma concentra3on profiles were similar to those ater inges3on with water and con3nued to display typical controlled release proper3es, consistent with maintenance of the controlled-‐release characteris3cs of the formula3on and without any evidence of dose dumping.
– There were no significant effects on the rate or extent of absorp3on of oxycodone ater administra3on of REMOXY with 4% or 20% ethanol and overall exposure was not affected.
– There was a minor increase in Cmax (10%) and exposure ater co-‐inges3on with 40% ethanol. Tmax was not affected by co-‐inges3on of REMOXY with ethanol from 4-‐40%
43 Confiden'al
MARKET DEVELOPMENT AND PROJECTIONS
Confiden'al
44
Confiden'al
45
Opioid Market Development 1 Share Point = 77 Million USD
Confiden'al 46
REMOXY Capture ProjecCons
STRATEGIC APPROACH…
Confiden'al
47
48
Strategy Under My Tutelage:
The strategic plan must be • Op3mized
• From the customer’s perspec3ve
• Include Posi3oning Analysis from “R” to “2B”
• Non-‐issues based
• Allow for tac3cal curve-‐fi}ng
• Fully-‐developed and approved
Strategic Optimization Model PEQ322 � Input Customer Data Here�
Confiden'al
49
OpCmizaCon
An op3mized strategic plan is... • Simply a roadmap. It tells us where we “R” today and where we need “2B” in the minds
of our customers in order to meet internal objec3ves. It is always an external view, never internally focused.
• Based on customer (both Rx’er and end-‐user) percep3ons at 3me points “R” and “2B”
• Customer percep3ons should be measured across several meaningful aoributes rela3ve to product profile, customer expecta3ons, and compe33ve profiles – it is that easy!
• Percep3ons are 80% reality (Peter Drucker -‐ modified Pareto’s Principle)
• Remember the marke3ng adage form product launches “You are not actually launched unless your customers can recognize and tell you that you are”
• Never issues-‐based! An issues-‐based plan is never op3mized. In an op3mized plan, issues are nothing more than a bump in the road. Planning for issues that may or may never occur waste planning 3me and resources. If an issue is large-‐enough to be included in the plan, then it is not an issue, rather a cri3cal success factor to overcome
• Simple to understand and communicate
Confiden'al
50
Sample PercepCon Analysis…
Example: Along 2 Aoributes: Sa3sfac3on and Loyalty Example: Along 5 Geographic Aoributes
Confiden'al
Mapping Stakeholders Interests vs. REMOXY Pain PosiCon
Confiden'al
51
Stakeholders • Pa3ents
– BID Pain Coverage with no breakthrough pain
– Less side-‐effects (no dose dumping)
• Physicians – Safety (no dose dumping) – Avoid diversion
• FDA – Promotes general safety to
the popula3on • Payers
– Stops PT doc-‐seeking cycle thus reducing total medical costs
– Avoid fraud and diversion
REMOXY Has Each Stakeholder Covered
P.E.S.T. (PoliCcal, Economic, Social, and Technological Analysis)
• Should be Included as part of planning
• Helps define cri3cal success pathways
52 Confiden'al
The PEST factors can be classified as opportuni3es and threats in the S.W.O.T.
S.W.O.T. -‐ IniCal Look
53 Confiden'al
• Controlled release mechanism intact ater 40% Ethanol • Tmax Significantly greater and 2X as long as OxyCon3n • Rate of absorp3on with 40% ethanol id similar to that of water • High bioavailability
• Slight rate of absorp3on increase • Small increase in Cmax ater co-‐inges3on with ethanol
• First true XRT oxycodone to market • Physicians will feel more comfortable prescribing • Managed Markets should provide coverage immediately
• FDA – stability issues • Unmo3vated or uninterested sales force
Strengths
Opp
ortuni3e
s Weaknesses
Threats
Internal Factors
External Factors
54
One Last Word On Strategy Development Most organiza3ons, independent of industry, spend very liole resources on strategy development
• Brand Engineers es3mates that less than 1% of budget dollars go toward strategy and posi3oning. “The irony in this is that these are the marke3ng aspects that ul3mately drive the vast majority of your spend. Even if you allocated 2% or 3% to ensuring appropriate strategic and posi3oning insight, would that s3ll be enough?”
Ill-‐Strategic planning leads to poorly op3mized tac3cal plans and can actually do more harm over the log-‐term
• Example: Quiznos Creatures Campaign
Bad Tac3cal Ideas*: The Quiznos creatures Superimposed over a Quiznos sub shop were two disturbing, singing rat-‐like creatures. No one wanted to eat in a place associated with disease-‐ridden rats.
Fortunately, the shop got wise and ditched them ater public outcry. But it’s an image that stays with you. Quiznos is s3ll recovering.
Go ahead, look them up on YouTube–but don’t say you weren’t warned. They are all too reminiscent of the sort of guys who hang outside a Quiznos and ask for your change!
*Entrepreneur Magazine, Ten Best and Worst Campaigns Ever, January 29, 2009
Confiden'al
55
“TACDEVEX”
• TAC3cal DEVelopmental EXercises are not new concepts
• There are countless exercises to prepare a team for posi3ve, crea3ve and enjoyable tac3cal planning.
Confiden'al
56
TacCcal Curve-‐Fikng
• Will fast, inexpensive “buses”, or large, preoy-‐to-‐look-‐at, slow-‐moving “yachts” to take you where you need to go on 3me?
• Not all tac3cal ideas are appropriate just because • everyone is doing it • it has been done this way for years • it is easy • it is proven to work
• This is where team crea3vity comes in...
Confiden'al
57
Aktude of Team Before Exercises
• Kioen vs. Baby Monkey A}tude* • Kioen in Danger or Confused -‐ meows and waits for mother • Baby Monkey -‐ runs to mother, jumps on her back and hangs on
for itself. • These exercises are for monkeys!
• Control Your “FUDs” • Nothing is more harmful to posi3ve crea3ve a}tude than fears,
uncertain3es and doubt (FUDs). When you are depressed, your thoughts are quite different from when you are happy. When you feel rich and successful, your thoughts are different from when you feel poor and inhibited.*
* Michael Michalko, Thinkertoys, 10-‐Speed Press, 1991
Confiden'al
58
Human Need for Consistency
• If thoughts are inconsistent with other, stronger ideas, then the mind will reject them.
• Example: Most people immediately see only one way to cut “13” in half.
* Michael Michalko, Cracking Crea3vity,p2, 10-‐Speed Press, 1991
Confiden'al
Need a Partner in Sales!!
Confiden'al
59
Find a way to mo3vate the troops while op3mizing the por�olio. It may translate into changes for the beoer.
Do we have enough SOV?
THANK YOU! Together, we can make the “World a Beoer Place”
Confiden'al
60
Timothy R. Roe!82 Sherry Lane Kensington, CT 06037
(860) 829-6688 Home (860) 518-5571 Cell [email protected] Email www.m2details.com Web
RESEARCH AND OTHER BACKUP SLIDES
Personal Research
61 Confiden'al
SEVERE PAIN HAS A MAJOR NEGATIVE IMPACT ON EMOTIONAL WELL-‐BEING
WHETHER OR NOT PAIN IS UNDER CONTROL
Source: American Society Web Site May 7, 2010
Husband describes wife’s pain as “almost being a third person in our marriage”.
62 Confiden'al
SEVERE PAIN HAS A MAJOR NEGATIVE IMPACT ON QUALITY OF LIFE
WHETHER OR NOT PAIN IS UNDER CONTROL
Source: American Society Web Site May 7, 2010 63
Confiden'al
Quality of Life Improvement on NarcoCc Pain Reliever
THE QUALITY OF LIFE HAS IMPROVED SIGNIFICANTLY AMONG THOSE WHO HAVE THEIR PAIN UNDER CONTROL.
Source: American Society Web Site May 7, 2010 64
Confiden'al
EMPLOYERS ARE NOT AS SUPPORTIVE AS CLOSE FAMILY AND FRIENDS OR DOCTORS
Source: American Society Web Site May 7, 2010 65
Confiden'al
PercepCon of Pain Relief by Drug Type
ALMOST 75% OF CHRONIC PAIN SUFFERERS PERCEIVE OTCs AS BEING EFFECTIVE IN RELIEVING MODERATE TO SEVERE PAIN
A MAJORITY ALSO BELIEVE NARCOTIC PAIN RELIEVERS AND Rx NSAIDS WOULD PROVIDE EFFECTIVE RELIEF
Source: American Society Web Site May 7, 2010 66
Confiden'al
Current Pain Relief MedicaCon Usage
Source: American Society Web Site May 7, 2010
THOSE WITH VERY SEVERE PAIN ARE MORE LIKELY TO USE ANTI-‐DEPRESSANTS AND ANTI-‐SEIZURE DRUGS
67 Confiden'al
OPINION IS SPLIT AMONG CHRONIC PAIN SUFFERERS BETWEEN WANTING TO TAKE PILLS ONLY WHEN NEEDED AND BEING ON A
REGULAR SCHEDULE
ALMOST ALL CHRONIC PAIN SUFFERERS TAKE THEIR MEDICINE IN PILL FORM; IT IS ALSO THE PREFERRED WAY.
Source: American Society Web Site May 7, 2010
A SMALL, BUT SIGNIFICANT NUMBER OF CHRONIC PAIN SUFFERERS HAVE AT ONE TIME OR ANOTHER TURNED TO ALCOHOL FOR RELIEF
68 Confiden'al
Severity of Pain for NarcoCc Users
Source: American Society Web Site May 7, 2010
69 Confiden'al
NarcoCc User -‐ SCgma Measurement AMONG THOSE WHO HEAR CONCERNS FROM OTHERS IT IS LIKELY TO BE A FAMILY MEMBER OR THEIR DOCTOR
Source: American Society Web Site May 7, 2010
70 Confiden'al
Risk EvaluaCon and MiCgaCon Strategy
Risk evalua3on and mi3ga3on strategies (REMS) formerly known as Risk Minimiza3on Ac3on Plans (RiskMAPs) are a regulatory technique for dealing with an3cipated risks of medica3ons and are especially important for new drugs with abuse poten3al.
71 Confiden'al