Letter Never Sent: Governor LePage and Zohydro
By Mike Reynolds
Ability Maine Staff
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
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.