Introduction:
Although it is a relatively small market, postherpetic
neuralgia (PHN) has served as a gateway indication into the lucrative
neuropathic pain (NP) market. Drugs such as gabapentin (Pfizer’s Neurontin,
generics), pregabalin (Pfizer’s Lyrica), and the 5% lidocaine patch
(Endo/Elan’s Lidoderm, Grünenthal’s Versatis) have capitalized on their
approvals for PHN and achieved wider commercial success in the treatment of
other forms of NP, such as painful diabetic neuropathy, neuropathic back pain,
and postsurgical/post-trauma NP. Drugs prescribed for PHN have limited
efficacy, making it the largest area of opportunity for drug developers, but
experts interviewed do not believe that any therapy in late-stage development
for PHN or other NP indication will demonstrate the efficacy needed to fulfill
this unmet need. On the other hand, many leading PHN therapies are associated
with considerable side effects that limit their use and/or unfavorable delivery
attributes such as frequent daily dosing or complex titration regimens.
Therefore, even incremental improvements in safety and/or tolerability and
delivery would allow drug developers to positively differentiate their
products.
Questions Answered in This Report:
*
A drug’s performance on at least six efficacy end points,
including effect on pain, is important for drug approval and physician use.
What
are the key primary and secondary clinical trial end points with which new
therapies are evaluated in PHN? How do U.S. and European neurologists weight
efficacy measures and other drug attributes in their prescribing decisions for
PHN?
*
Pregabalin was the 2008 major-market sales leader for PHN.
How
will pregabalin and other current therapies fare against emerging therapies?
Will emerging therapies offer improvements in drug attributes that are most
influential in physician prescribing decisions? If so, which drugs will suffer
the most from entry of these new agents?
*
Based on its clinical profile, the 5% lidocaine patch
(Endo/Elan’s Lidoderm, Grünenthal’s Versatis) is the 2009 clinical gold
standard in our proprietary Drug Comparator Model.
What attributes do
thought leaders believe differentiate this drug from competing current and
emerging therapies? Will any drugs in development challenge 5% lidocaine patch
as the future gold standard in 2013 or 2018?Scope:
Key drug development opportunity tested in our target
product profiles for PHN: a novel formulation of gabapentin that is dosed
once or twice daily.
Physicians surveyed for this study: 60 U.S. and 33
European neurologists.
Comprehensive List of Therapies Included in Our Research and Modeling
Current Therapies
- Pregabalin (Pfizer’s Lyrica)
- Gabapentin (Pfizer’s Neurontin, generics)
- 5% lidocaine patch (Endo/Elan’s Lidoderm, Grünenthal’s
Versatis)
- Duloxetine (Eli Lilly/Boehringer Ingelheim’s Cymbalta/Xeristar)
- Tramadol ER (Ortho-McNeil’s Ultram ER, Labopharm’s
Tramadolor/Unitrama/Dolpar/Tridural, generics)
Emerging Therapies
- Gabapentin enacarbil (XenoPort/GlaxoSmithKline/Astellas’s
Horizant)
- Gabapentin GR (Depomed/Solvay/Abbott)
- NGX-4010 (NeurogesX/Astellas’s Qutenza)
- Tapentadol ER (Johnson & Johnson/Grünenthal’s Nucynta ER)
- Bupivacaine patch (Durect/King’s Eladur)