Advocacy groups are unhappy about a new drug that is expected to be on the market within weeks, according to a letter signed by 40 organizations sent in February 2014 to the federal Food and Drug Administration (FDA). The letter calls on the FDA to revoke its October 2013 market approval for Zohydro, a powerful new opiate painkiller that poses a high risk for both overdose and addiction and is projected to generate more than $200 million in sales.
The drug is a formulation of the narcotic hydrocodone painkiller in capsule form. It does not contain acetaminophen, which can cause liver damage. Zohydro will be available in six dosage strengths, ranging from 10 mg to 50 mg, making the capsules five to ten times stronger than existing narcotic hydrocodone medications, which are combined with acetaminophen, a non-narcotic painkiller. The new medication can be taken every 12 hours, while the existing drugs require administration every four to six hours.
Other companies, including Purdue Pharma, the maker of OxyContin, are reportedly researching extended release versions of the drug.
DEA Plans To Tighten Controls On Opiate Painkillers
Meanwhile, a proposal to reclassify hydrocodone combination products (those diluted with acetaminophen) was published in the Federal Register on February 27. If approved, the proposal would increase controls on the powerful drugs by moving them from Schedule III to Schedule II of the Controlled Substances Act. The move reflects recommendations by the department of Health and Human Services and the FDA. Public comment will be accepted until April 27, 2014.
Schedule II drugs can only be prescribed one bottle at a time, without refills, while Schedule III drugs can be refilled up to six times without seeing a physician.
Letter Says The Last Thing The U.S. Needs Is A New, Dangerous High-Dose Opioid
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” says the letter, signed by a coalition of addiction treatment centers and consumer watchdog groups including Public Citizen.
Increased prescribing of opioids is associated with several factors, including an increase in chronic pain due to an aging population. The number of people living with chronic pain in the U.S. has been rising steadily, and prescription opioid painkillers have become the mainstay of treatment over the past 20 years. However, almost 5 million people over the age of 12 in the U.S. abuse pain medications, according to federal data.
Opioid analgesics such as oxycodone and hydrocodone are involved in roughly three out of four drug overdose deaths. An analysis of drug overdoses by the federal Centers for Disease Control (CDC) found that the number of drug overdose deaths involving opioid analgesics rose from 4,030 in 1999 to 16,651 in 2010.
Zohydro™ ER (extended release) is an opioid agonist, extended-release oral formulation of hydrocodone bitartrate, indicated for “management of pain severe enough to require daily, around –the-clock, long-term opioid treatment,” when alternative treatment options are inadequate, says San Diego-based manufacturer Zogenix, Inc.
Opposition Grows To FDA Market Approval For Zohydro
The February 2014 letter supports one from 29 attorneys general who sent a letter in December 2013 to FDA Commissioner Dr. Margaret Hamburg, calling on the FDA to either reconsider its approval for Zohydro or set a rigorous timeline for the development of a formulation with abuse-deterrent properties. Another letter, from four U.S. senators, said the approval “will only contribute to the rising toll of addiction and death” caused by the epidemic of prescription drug abuse.
According to the DEA, hydrocodone is the most frequently prescribed opiate in the U.S., with nearly 143 million prescriptions for hydrocodone-containing products dispensed in 2012. There are several hundred brand name and generic hydrocodone products currently on the market, all of them combination products. The most frequently prescribed combination is hydrocodone and acetaminophen. Prescription opioids include hydrocodone (Vicodin®), oxycodone (OxyContin®), propoxyphene®, hydromorphone (Dilaudid®), meperdine (Demerol®), and diphenoxylate (Lomotil®).
Lack Of Abuse-Deterrent Properties Criticized
The potency of Zohydro has prompted concerns that it could easily be fatal for new patients or children. Another concern is that people will attempt to crush and snort or inject it to get high. The pharmaceutical drug manufacturing industry has recently focused on the development of tamper-resistant drug delivery systems that make the active ingredients unavailable for unintended routes of administration. One approach is to add a substance to tablets that causes the ingredients to form a gel when mixed with water or alcohol, preventing injection. Other ingredients include nasal irritants to prevent snorting.
Shortly after the drug received FDA approval, Zogenix announced that it had signed an agreement with Altus Formulation, Inc. to develop a tamper-resistant formulation. In 2013, Zogenix said it was “a few years away” from developing a tamper-resistant formula.
The FDA approval for Zohydro disregarded an 11-2 vote against approval (with one abstention) in 2012 by an appointed FDA advisory panel of medical experts. One of the concerns voiced repeatedly at that hearing was the lack of an abuse-deterrent strategy for Zohydro ER.
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