Transcript Emerging & Novel Pharmacotherapy Approaches in Pain Management

Emerging & Novel
Pharmacotherapy Approaches
in Pain Management
Maria G. Guevara, Pharm.D.
Pain & Palliative Care Resident
Lakeland Regional Medical Center
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Objectives
Identify new dosage forms for pain
management
Identify medications with novel
mechanisms of action for pain
management
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Pain and Drug Therapy
Pain
– Primary reason patients seek out healthcare
– Chronic pain affects 1 of 3 Americans
– Postoperatively, over 50% of patients receive
inadequate pain control
Medications continue to be the
cornerstone of pain management
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Emerging Therapies
Relatively few new medications approved
in last few years
Market flooded with formulation changes,
long-acting opioids
– No novel or unique medications
Numerous medications, including new
classes
– Available
– Coming soon
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New Therapies
Available
– Transdermal
diclofenac
Other
– Purified capsaicin
– Milnacipran
Coming Soon
– Tapentadol
– Iontophoretic
fentanyl
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Transdermal Diclofenac
Flector® (Patch)
Indication
Acute pain due to
minor sprains &
strains
Dose
1.3% diclofenac
epolamine
180 mg Q 12h
(<1% 50 mg PO)
Potential
Convenient
Advantage application/dosing
Voltaren® (Gel)
Osteoarthritis of
joints- knees &
hands
1% diclofenac
sodium
2 to 4 g QID
(6% 50 mg PO)
Indicated for
chronic OA pain
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Transdermal Diclofenac (con’t)
Minimal systemic absorption
Most common ADR: application site
reaction
Contraindications
– Hypersensitivity to diclofenac
– Asthma, urticaria, allergic reaction to NSAIDs
– Post-op CABG
– Non-intact skin
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Tapentadol
Novel, centrally acting oral analgesic
– Similar to tramadol
– Mu opioid agonist
– Inhibits norepinephrine reuptake
Efficacy/Toxicity
– 50-100 mg dosing found similar in efficacy to
oral oxycodone 10-15 mg per dose
– Less nausea, vomiting, constipation
compared to oxycodone
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Tapentadol (con’t)
Effective v. placebo in 2,100 patients
– Bunionectomy
– Low back pain, osteoarthritis of knee & hip
Immediate release formulation approved in
November 2008; available early 2009
Indication: moderate to severe acute pain
Dosing: 50 to 100 mg q 4 to 6 h
Available in 50, 75, 100 mg tablets
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Ionsys® (Iontophoretic Fentanyl)
Fentanyl delivered via
iontophoresis
Not commercially
available yet
– Battery powered
– Creates small electrical
current
– Forces ionized drug
through the dermis
Approved January 2006
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Ionsys® (con’t)
Indication
– Short-term management of acute
postoperative pain in adults
– Inpatient use only
40 mcg on demand, 10 minute lockout
Not programmable
Absorption: 16 mcg on first push, about 10
hours to reach 40 mcg dose
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Ionsys® - Efficacy
Comparable efficacy to morphine IV PCA
34-48% of patients required breakthrough
fentanyl IV (fentanyl vs placebo)
– Compared to over 50% of placebo patients
Improved overall ratings regarding
– Ease of care
– Patients and nurses
Unlikely to be used as monotherapy
Minkowitz et al Pain Med 2007.
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Adlea ® (Capsaicin)
Purified capsaicin
Long duration of action
Transient receptor potential vanilloid 1
receptor (TRPV-1) antagonist
– Activated during inflammatory response
– Modulates chronic pain, hyperalgesia
– Contributes to pain associated with
inflammation
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Adlea® (con’t)
Missed Phase III endpoints for pain
reduction post-op bunionectomy
– Instilled into surgical site prior to close
– Reduction of pain 4 to 32 hours post-op
– Reduction of rescue opioid
– ADRs similar to placebo
Other oral, topical TRPV-1 antagonists in
Phase I or Phase II trials
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Milnacipran
SNRI antidepressant
Equal reuptake inhibition of 5-HT & NE
No action at noradrenergic, muscarinic or
histaminergic receptors
Available in Europe (Ixel®)
– Indication for major depressive disorder
Currently in Phase III studies
– Seeking indication for fibromyalgia
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Summary
Transdermal diclofenac (Flector®,
Voltaren®) currently available
Tapentadol, iontophoretic fentanyl
(Ionsys®) coming soon
Purified capsaicin (Adlea®) recently
missed Phase III endpoints
Milnacipran in Phase III studies for
fibromyalgia
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Questions???
[email protected]
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