In an Increasingly Generic Market, Replete with Well-Established Oral Therapies, What Drug Development Opportunities Remain?
In 2012, painful diabetic neuropathy (PDN) affected more than 7.4 million people in the major pharmaceutical markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan); due to an aging population and increases in obesity and type 2 diabetes, this market is expected to grow to more than 9.5 million by 2022. In addition to offering a rather large treatable patient population, PDN has and will continue to serve as a gateway indication into the broader, more-lucrative neuropathic pain (NP) market. No available therapies for PDN, and NP in general, can fully alleviate patients’ pain; interviewed experts report that, despite the availability of a large array of therapies from multiple drug classes, physicians are at best able to achieve 50% pain relief in 50% of their PDN patients with any single therapy. The limited efficacy and tolerability of currently available therapies translate into a high level of unmet need and potential opportunity for novel agents. However, emerging pain therapies will enter a market that contains many well-established, relatively inexpensive early-line therapies and will encounter a growing generics presence. As a result, emerging therapies attempting to attain premium pricing in this market will need to offer substantial improvements in efficacy, safety, and/or delivery over currently available therapies to achieve commercial success.
Attributes included in conjoint analysis-based assessment of target product profiles for PDN:
- Reduction in 11-point pain intensity score.
- Percentage of patients achieving ≥ 50% reduction in pain intensity score.
- Percentage of patients reporting “much improved” or “very much improved” on the Patient Global Impression of Change (PGIC) scale.
- Incidence of weight gain; percentage of patients reporting a gain of 7% or more over baseline.
- Dosing frequency.
- Dosage formulation.
Attributes included in assessment of U.S. payers’ receptivity to new therapies for PDN:
- Patient responder rate (percentage of patients achieving a ≥ 50% reduction in pain).
- Effect on global outcomes (percentage of patients reporting “much improved” or “very much improved” on the PGIC scale).
- Delivery characteristics.
- Average weight change (pounds [lbs] lost or gained).
Physicians surveyed: 62 U.S. and 30 European neurologists.
Payers surveyed: 20 U.S. MCO PDs.
Comprehensive List of Therapies Included in Our Research and Modeling:
- Pregabalin (Pfizer’s Lyrica)
- Gabapentin (Pfizer’s Neurontin, generics)
- Duloxetine (Eli Lilly/Shionogi’s Cymbalta/Xeristar, generics)
- 5% lidocaine patch (Endo’s Lidoderm, Grünenthal’s Versatis, generics)
- Tapentadol ER (Janssen’s Nucynta ER, Grünenthal’s Palexia SR)
- Pregabalin CR (Pfizer)
- Capsaicin topical solution (Acorda Therapeutics’ NP-1998)
- Clonidine topical gel (BioDelivery Sciences)
- XEN-402 (topical) (Teva/Xenon)
- Eslicarbazepine acetate (Bial)