Rebuttal: “The Big Money Is In Extended-Release”
A few participants in our discussion this week have suggested that the market for immediate-release opioids may be “nice” but “the big money is in extended release” opioids. On a per prescription basis, that is absolutely true. But as we’ve shown in multiple graphs, the number of prescriptions for immediate-release opioids outpaces extended-release scripts by a factor of nine to one. The total dollars in U.S sales are about equal: $3.9 billion for IR vs. $4.1 billion for ER (2012).
No doubt extended-release opioids for chronic pain represent “big money.” But many of the patients in that market are already on a stable regimen with an abuse-deterrent formulation. The FDA has already given their approval to hard-shell and gummy-shell ADF (OxyContin, Zohydro). We know, and the HAL and efficacy studies will prove, that our two-bead, modular, pharmacology-based ADF with naltrexone is the very best for multiple reasons. But the FDA has repeatedly re-enforced that physical barrier ADT is good enough, and I strongly doubt that any doctor is going to change a patient who is stable on a medication to an entirely different medication just because naltrexone-based ADF becomes available.
For this reason, I believe that our naltrexone-ADF opioids will gain market share mostly with “new users” and less with “current users.” For chronic pain, when a patient is being started on extended-release opioids for the first time, naltrexone-based ADF will garner a percentage of these prescriptions and will build market share slowly over time. But immediate-release opioids, which account for 90% of the prescriptions, are used primarily for acute pain, and all acute pain patients are “new users.” And since there are very few competitors with immediate-release ADF opioids, Elite’s naltrexone-ADF will build market share in the immediate-release opioid market much more quickly than it will build market share in the extended-release market.
So to those who say the big money is in the extended-release market, I say I agree. But the early money, and easiest money, is in the immediate-release market. And the greatest part is that with Elite’s modular two-bead technology, we’ll quickly be gaining market share in every market: oxycodone, hydrocodone, morphine, hydromorphone, oxymorphone, extended-release, and immediate-release.
