Wednesday, August 17, 2016

More drugs.

According to the Philadelphia's "The Inquirer", Medical advisers to the FDA have recommended approval of a new abuse-deterrent formulation (ADF) opioid named Arymo ER by Egalet Corp. In fact, the vote was overwhelming; 18-1. This new painkiller is an extended-release morphine that comes in 15mg, 30mg and 60mg doses. A final decision by the FDA on that recommendation is expected by mid-October.
When compared to MS-Contin, a pharmacologist with the FDA reportedly said ...
The numerical difference or outcome in the data was less than 5 percent, raising a question about Arymo's "clinical relevance"
I applaud the concept of abuse-deterrence formulations of opioids and other dangerous drugs that can be abused. I appreciate the fact there truly are some people that need opioids for "before/during/immediately after surgery, cancer, AIDS/HIV, end-of-life care" (my broadbrush interpretation of appropriate use of opioids). I agree abuse (non-medical use) is rampant with opioids (and other dangerous drugs). I am an "all of the above" (all options on the table) kind of person when it comes to resolving our painkiller epidemic, and I do think ADF has a part to play.
But to me the bigger problem is ... legitimate prescriptions by legitimate prescribers used legitimately by patients that are clinically inappropriate. Especially for the mostly inappropriate treatment of chronic pain.
So is the introduction of a new drug just propping up bad practice? Is Big Pharma using ADF to maintain their revenues (will Arymo be a money-maker)? Will we see abuse of non-ADF drugs decline? Will we see prescriptions change from non-ADF to their ADF equivalents? Will we see generics (the majority of drugs prescribed & dispensed) also become ADF? As usual, I have more questions than answers.

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