Game Changing Plays in the Pain Market
January 8th, 2009Ginger S. Johnson, PhD
For this presentation we will highlight game changing events taking place in the area of pain (some of which are outlined below) and discuss the impact on future market dynamics and strategies for companies who want to compete in this space.
• A return to branded opioids with the H2:08 re-launch of re-branded OxyContin (Purdue Pharma), after settlement with generic manufacturers Endo, Teva and Impax/Dava. Purdue will clearly benefit, but will other branded agents such as Opana ER (Endo/Penwest), Avinza (King/Ligand) and Kadian (Alpharma) as well?
• The entry of abuse-deterrent opioids, with King/Pain Therapeutics (Remoxy, oxycodone ER) and Purdue (novel formulation of OxyContin) in a race to be first to market. While clinicians and regulatory authorities alike realize that it is only a matter of time before the hard core drug abusers / dealers are able to circumvent these road blocks, they do promise to address abuse, misuse and diversion issues overall. However, in the presence of generic alternatives, does it make sense to prescribe a high-priced, branded abuse-deterrent opioid for the larger patient populations that are not considered to be the source of the problem (e.g., cancer-related pain)?
• The FDA’s ever-increasing toughness on safety requirements is leading to limited label indications and maximal label warnings. This is reflected in the May 2009 FDA advisory panel ruling against the expanded use of Cephalon’s fentanyl product, Fentora as a treatment for non-cancer patients. Endo and Alexza hope for a more positive result from the FDA advisory panel for their early-stage inhaled fentanyl product which utilizes Alexza’s proprietary Staccato system. The Endo/Alexza product incorporates security and safety benefits that the company hopes will allow for a broader label indication for the treatment of non-cancer pain.
• The early success of the first transdermal NSAID on the US market, Alpharma/IBSA’s Flector (diclofenac patch, approved January 2007), heralds a large market opportunity that will likely accommodate several players. In fact, the second market entrant, Endo/Novartis’ Voltaren (diclofenac) Gel has seen a similarly impressive market uptake. There are a number of other topical prescription NSAID products in development, including Zars’ Thermoprofen (Phase III), Endo/ProEthic’s ketoprofen patch (Phase III), Nuvo Research’s Pennsaid (diclofenac cream; “approvable”), Alpharma/IDEA AG’s Diractin (ketoprofen gel; Phase II), and Cerimon’s topical diclofenac patch (Phase I).
• For the first time in a long, long time, we see novel mechanisms that look promising in the pain space. While much of the pipeline is focused on reformulations and fixed-dose combinations of existing μ-opioid agonists, we are seeing the development of new classes of agents for the treatment of pain such as nerve growth factor (NGF) antagonists (Rinat/Pfizer, Amgen), delta opioid receptor (DOR) agonists (Adolor/Pfizer), transient receptor potential vanilloid subtype-1 (TRPV1) antagonists (Renovis now Evotec/Pfizer, Glenmark Pharmaceuticals/Eli Lilly) and J&J’s newly approved agent, tapentadol, a dual mode analgesic that inhibits norepinephrine uptake and has μ-opioid receptor agonism.
