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"Letter Never Sent: Governor LePage and Zohydro"

Written By:

Mike Reynolds

On Friday, August 29th, 2014 The Associated Press reported that Maine Governor Paul LePage signed on to a letter with five other governors from New England addressed to the commissioner of the FDA to withdraw approval of the controversial new drug Zohydro. Zohydro is a new stronger formulation of Hydrocodone, the active ingredient in Vicodin. There are a number of concerns, chief among them the fact that the medication  contained in one Zohydro will be equal to five Vicodin pills. Unlike Vicodin, Zohydro does not contain Acedomediphen, the active ingredient in Tylenol. The manufacturer of Zohydro, Zogenix, states that this formulation is a benefit, as long term use of Tylenol can cause liver issues.

The drug is encapsulated with a gelatin coating to deliver the drug over a long period of time. However, The drug can be cut, leaving the pure Hydrocodone able to be used, or abused, a fear many in government, medical and other fields share given that the year has seen the state of Maine, actually all of New England, a rise in opiate drug use, abuse, and overdoses.   

Zohydro has been controversial even before it's approval by the FDA, with an advisory committee of the same agency recommending that the drug not be approved in late 2012. Attorneys General from 28 statesalso wrote the FDA asking the drug not be approved. The makers of the drug Zogenix, state that they are working on adding abuse resistant components to ZoHydro. Zohydro went on sale in March across the country, with no abuse deterrent in it's formulation.  

Many credit the introduction a reformulation of Oxycontin in 2011, another time released opiate which worked similar to Zohydro, to include abuse resistant technology in a reduction of drug related overdoses and deaths.  The reformulation was approved as abuse resistant by the FDA in April 2013. Oxycontin was approved for use in 1996. According to a May 26, 2014 Wall Street Journal article, Purdue Pharma, makers of Oxycontin,has applied for a approval of it's high dose Hydrocodone medication, with abuse deterrent technology already in it's formulation. Zohydro is currently the only medication Zogenix has on the market.

On September 4th, The Associated Press issued a correction that Governor Paul LePage did not sign on to the letter with the other governors. It's a shame but not surprising that Gov. LePage did not sign the letter to the FDA Commissioner. LePage has cited the opiate abuse crisis earlier this spring when he wanted the Maine Legislature to approve an emergency bill to fund an expansion to the Maine Drug Enforcement Administration. The Legislature never voted on his request. 

Zohydro provides an frustrating dilemma; Zogenix has created a drugwhich does exactly what it's target market needs, provides an opitate level of pain relief without additional doses of Tylenol that could cause liver issues, and delivers the medication over an extended period.  For a Cancer patient going through chemo, it is a drug that may be useful. It's also the only drug it's maker, Zogenix, has on the market.  Pulling the drug off the market would surely be catastrophic to the company. The rates of prescriptions written seem to be small, focusing this drug on the most severe of patients and pain. It would be wonderful if Zohydro had anti abuse features in it's current formuation; it took the makers of Oxycontin over fifteen years from it's introduction to have their reformulation deemed as such by the FDA.  

Independently of the letters to the FDA, Hydrocodone as a drug was reclassifed in August such that any drug that contains Hydrocodone is now, as of October 6, 2014. is a Schedule II drug. Prior to that only drugs that ONLY had Hydrocodone were Schedule II, and drugs which combined Hydrocodone with other drugs were classified as Schedule III. The restrictions of a Schedule II drug state that a physical prescription must be shown when the drug is prescribed. The prescription can have up to 90 days supply in refills.  One potential issue, given that Maine is a rural state and does rely on the use of Physician's Assisant's, will be that they will no longer be able to prescribe ANY medication that incluces Hydrocodone. 

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