A coalition of addiction treatment experts, healthcare agencies and consumer groups is calling on the Food and Drug Administration to revoke its approval of Zohydro, a potent extended release opioid painkiller that will be introduced next month by San Diego based Zogenix Inc. (NASDAQ: ZGNX).
“We ask you to put the public’s health ahead of industry efforts. 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,” the FED UP! Coalition wrote in a letter to FDA Commissioner Margaret Hamburg.
The letter is signed by representatives from 42 different organizations, including Physicians for Responsible Opioid Prescribing (PROP), Phoenix House, Public Citizen, the American Society of Addiction Medicine, and Advocates for the Reform of Prescription Opioids.
In recent months, several congressmen and the attorneys general from 29 states have also written to the FDA, asking the agency to reconsider its decision to approve Zohydro, which will the first pure hydrocodone painkiller sold in the U.S.
The agency approved Zohydro last October over the objections of its staff and advisory committee, which warned there was potential for Zohydro to be abused even more than currently available hydrocodone combination products.
“The highest available dosage of Zohydro will contain 5 to 10 times more hydrocodone than Vicodin or Lortab. Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child,” said the letter from FED UP!
Combination versions of hydrocodone, such as Vicodin, typically contain acetaminophen and require dosing every 4 to 6 hours. Extended release Zohydro could be taken just twice a day for chronic pain. It is being introduced without a tamper resistant formula to discourage drug addicts from crushing or liquefy the pills in order to snort or inject the drug.
Zogenix claims Zohydro will actually be safer than other hydrocodone combination products because it does not contain acetaminophen – which can lead to acute liver failure if taken in high doses.
“Zohydro is not safer,” the FED UP! letter states. “For patients unable to tolerate acetaminophen, many opioid formulations made without acetaminophen are already available. There is no need for another high-dose, single-entity opioid.”
There was no immediate response to the letter from the FDA.
“We are confident in the decision by the U.S. Food and Drug Administration to approve Zohydro ER after an extended, 18-month, comprehensive and thorough review process. The FDA concluded that the benefits of Zohydro ER outweigh the risks,” Zogenix said in a statement.
Zogenix is preparing for Zohydro’s commercial launch in early March. The company recently said the painkiller was ready for shipment to wholesalers and that adequate inventory is in place to meet anticipated demand for the drug.
“I’m worried about their plan to market the drug for back pain and other common problems,” said Judy Rummler, chair of the FED UP! Coalition and president of the Steve Rummler Hope Foundation. Rummler’s son Steve died of a drug overdose in 2011, after becoming addicted to painkillers that were prescribed to him for his chronic back pain.
“The capsules will contain a whopping dose of hydrocodone,” said Pete Jackson, president of Advocates for the Reform of Prescription Opioids. Jackson lost his 18-year-old daughter Emily to a single dose of OxyContin in 2006.
“It’s crazy to let this drug go on the market as it undoubtedly will become the next OxyContin that will fuel the opioid addiction epidemic.”
One addiction treatment expert who did not sign the letter says Zohydro will be under such close scrutiny it’s unlikely to be widely abused.
“The opposition to Zohydro is like closing the gate after the horse has left the barn,” said Percy Menzies, president of Assisted Recovery Centers of America, in an email to National Pain Report.
“It is very unlikely that this product will be indiscriminately marketed as happened in the past. Pharmaceutical companies, including the makers of Zyhydro, are going to be extremely cautious about marketing it indiscriminately. The approval is coming at a time of great concern about excessive use of acetaminophen. I do not see Zyhydro or any single entity opioid making things any worse. The FDA has initiated strong strategies like REMS to minimize the abuse of opioid pain medications.”
Zohydro will be classified as a Schedule II drug, which means it can only be dispensed through a physician’s written prescription, with no automatic refills allowed. There are also more stringent recordkeeping, reporting, and security requirements for Schedule II drugs.
So far at least one health insurance company has indicated it is willing to reimburse patients and healthcare providers for Zohydro prescriptions.
In a note to providers about its coverage policy for Zohydro, Humana said it would authorize Zohydro prescriptions for patients who have pain severe enough for daily, around-the-clock opioid treatment; but only if they had already tried at least two other long-acting opioids and found them to be ineffective. The insurer also wants patients to sign pain management agreements with their provider before being prescribed Zohydro.