Massachusetts to Ban FDA-Approved Zohydro ER

Megan Brooks

April 01, 2014

Officials in Massachusetts have announced plans to ban the sale of the single-entity extended-release hydrocodone product (Zohydro ER, Zogenix Inc) recently approved by the US Food and Drug Administration (FDA).

On March 27, Massachusetts governor Deval Patrick declared a public health emergency in his state in response to the growing opioid addiction epidemic.

He directed the state's Department of Public Health (DPH) to take several steps to "combat overdoses, stop the epidemic from getting worse, help those already addicted to recover and map a long-term solution to ending widespread opiate abuse in the Commonwealth," according to his statement.

The governor has dedicated $20 million to enhance substance abuse treatment programs in the state.

His public health emergency declaration grants emergency powers to DPH Commissioner Cheryl Bartlett, RN. At the governor's direction, Commissioner Bartlett will work with the Public Health Council to take a number of steps, including prohibiting prescribing and dispensing of any hydrocodone-only formulation until adequate measures are in place to protect against potential diversion, overdose, and misuse.

"The introduction of this new painkiller (Zohydro ER) into the market poses a significant risk to individuals already addicted to opiates and to the public at large," the governor's statement reads.

The action isn't sitting well with the drugmaker.

In a statement, Zogenix called the move "unprecedented" and said it "only serves to unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients who are obtaining relief with short-acting hydrocodone combination products, but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen."

"Ultimately, the ban on the prescription medication will add to patient suffering in the state," the statement reads.

Public Health Emergency

Other steps to be undertaken to combat addiction in the state include the following:

  1. Universally permit first responders to carry and administer the opioid antagonist naloxone (Narcan), which can reverse an overdose when given in a timely fashion. Naloxone will also be made widely available through standing-order prescription in pharmacies in order to provide greater access to family and friends who fear a loved one might overdose.

  2. The DPH will mandate the use of prescription monitoring by physicians and pharmacies to better safeguard against abuse or misuse. This was previously a voluntary program.

  3. Retask the Commonwealth's Interagency Council on Substance Abuse and Prevention with added members from public health, provider organizations, law enforcement, municipalities, and families affected by the opiate epidemic to make recommendations in 60 days on further actions that can be taken, including, but not limited to, how to better coordinate services, ensure a full range of treatment regardless of insurance, and divert nonviolent criminal defendants struggling with addiction into treatment programs.

The use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts, Governor Patrick said.  At least 140 people have died of suspected heroin overdoses in communities across the commonwealth in the last several months, "levels previously unseen." From 2000 to 2012, the number of unintentional opiate overdoses increased by 90%.

"We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is," the governor said.

Pressure Mounts

In their statement, Zogenix said, "We agree with Governor Deval Patrick's intention to curb the epidemic of drug abuse in Massachusetts. However, we are extremely concerned by his unprecedented action with respect to a specific FDA-approved prescription medication."

The FDA cleared Zohydro in October 2013 over the objections of its own advisory panel, which expressed concerns about the potential for abuse and voted 11 to 2 against approval.

Since approval, the drug has been at the center of a firestorm. Consumer groups and attorneys general of 29 states and territories have asked the FDA to consider reversing its approval of the drug, and bills have been introduced in both the House and Senate to keep the powerful opioid off the market and prohibit the FDA from approving any similar product unless formulated to prevent abuse.

Zogenix counters that in the last year, more than 360,000 prescriptions for extended-release opioids were dispensed in the state, and "a significant majority did not have FDA-approved abuse deterrent claims."

On the Massachusetts ban, Zogenix said, "We fail to see how banning the sale of a single new product will achieve the governor's policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state."

The company points out that the US Drug Enforcement Administration assigns an allocation, or quota, for how much medicine manufacturers of opioids can make each year. "It is important to know that the quota for Zohydro ER is less than 1% of the total allotted hydrocodone product that will be manufactured in the US this year," the company said.

Zohydro ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

It is not approved for as-needed pain relief and was approved with a risk evaluation and mitigation strategy, which requires companies to develop educational programs on how to safety prescribe these agents to healthcare professionals and provide medication guides and patient counseling documents with information on safe use, storage, and disposal of extended-release/long-acting opioids.

"We look forward to engaging with the [Massachusetts] governor and his representatives to review the safe use measures already in place," Zogenix said.

Since approval of Zogenix ER, topline phase 3 results with a single-entity hydrocodone with abuse-deterrent properties have been reported in patients with chronic low back pain.

If approved, the agent (hydrocodone bitartrate, Purdue Pharma LP) would be the first extended-release hydrocodone product with abuse-deterrent properties, Purdue said in a statement. Although not totally abuse-proof, the product contains a polymer that makes it difficult to crush; it becomes gummy, which prevents it from being easily snorted or drawn into a syringe to inject.


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