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The Anesthetic and Analgesic Drug Products Advisory Committee of the FDA will meet on April 22, 2014, to review the New Drug Application for Moxduo, also known as Q8003, an investigational new drug from QRxPharma. Moxduo IR is an opioid-opioid analgesic, composed of morphine and oxycodone. The drug is aimed at "patients suffering from moderate-to-severe acute pain" and has an addressable market of 214 million prescriptions per year. QRxPharma hopes that this drug will replace Vicodin and Percocet, which face new FDA restrictions due to liver toxicity danger stemming from their acetaminophen components.
The Allentown Family Health Examiner spoke with Dr. Andrew Kolodny, who is the Chief Medical Officer of Phoenix House, an addiction recovery center, as well as the founder of Physicians for Responsible Opioid Prescribing. Dr. Kolodny described the potential public health dangers of Moxduo IR, as well as sharing some of his overall thoughts regarding the opioid abuse and addiction epidemic in the United States.
Q: Thoughts on the upcoming FDA panel review of Moxduo IR?
A: I'm happy to share my thoughts with you. We are opposed to the release of Moxduo. I will say that I was somewhat pleased that the indication they were seeking for it is acute pain, rather than chronic pain -- because opioids are probably safe and effective when you use them short term for acute pain, unlike chronic non-cancer pain -- but we have serious concerns about this product mainly because the product that Moxduo will be competing with will be Vicodin.
Vicodin (and Lortab and other brand names) comes in varying strengths, from 2 mg of hydrocodone to a maximum of 10 mg of hydrocodone. So the problem is that Moxduo IR will be competing with Vicodin, and because Vicodin comes in low doses mixed with Tylenol -- and combination products can also have an NSAID in there -- and there's talc and cornstarch and other fillers -- if you're addicted and want an opioid you can snort, Vicodin is not a very attractive product. In many ways it's an abuse-deterrent formulation. All the stuff in there mixed in with the opioid makes it less easy to abuse.
If somebody is addicted, or wants to abuse an opioid, Moxduo is a perfect product. You can crush it and snort it or inject it. It's more dangerous than the competing product. It's offering nothing new, and because it's more dangerous than the competing product, we think it will exacerbate the opioid addiction epidemic.
We don't think we need new opioids. If you listen to what the CDC is saying is the cause of this epidemic, it's been the medical community over-prescribing. As prescriptions began to soar in the late 1990s, there is a parallel increase in addictions and deaths.
Every time a new product gets released, the company that invested in bringing the product to market needs to recoup their investment, and they do that by sending drug reps to doctors' and dentists' offices. The last thing we need are drug reps going to doctors and dentists encouraging them to prescribe more opioids. The fact that FDA would even consider approving another opioid product is an indication of how wrongly they're thinking.
Q: Are you going to DC on April 22nd to speak to the Anesthetic and Analgesic Panel about Moxduo?
A: It's funny that you ask. The Moxduo meeting is scheduled on April 22nd, which is exactly the same time as the RX Drug Summit. I'm going to be at that meeting, and the commissioner of FDA and the person who heads up opioid policy at FDA are going to be there as well. A lot of the people who would show up at the panel meeting and speak out against Moxduo are going to be at that meeting.
It could just be a coincidence, or it could be that [after approving Zohydro contrary to the panel's 11-2 recommendation against approval] they figured if the folks who typically show up and convince the panel members to vote against the product don't show up, they'll have a better shot [at the panel recommending approval].