Three U.S. senators are raising concerns about Zohydro, a new extended release painkiller that will be introduced next month by San Diego based Zogenix Inc. (NASDAQ: ZGNX).
Republicans Mitch McConnell of Kentucky, Tom Coburn of Oklahoma and Lamar Alexander of Tennessee sent a letter to the Food and Drug Administration asking how the agency will prevent the misuse and abuse of Zohydro, which will the first pure hydrocodone painkiller sold in the U.S.
The FDA 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.
“Given this clear warning from the FDA’s advisory panel, we would like to know what safeguards FDA mandated for the product,” the senators said in the letter to FDA commissioner Margaret Hamburg.
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.
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.
In December, 29 U.S. Attorneys General wrote to the FDA asking the agency to reconsider its approval of Zohydro.
“We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse deterrent properties,” the letter says.
This week Zogenix said is was preparing for Zohydro’s commercial launch in early March. The company said the painkiller was ready for shipment to wholesalers and that adequate inventory is in place to meet anticipated demand for the drug.
Zohydro is being introduced without a tamper resistant formulation to discourage drug abuse. Addicts often crush or liquefy painkillers such as oxycodone to snort or inject the drug.
Zogenix is developing an abuse deterrent formulation for Zohydro. In 2013, the company said it was “a few years” away from developing such a formula.
The company claims its new drug will actually be a safer formulation of hydrocodone because it does not contain acetaminophen – which can lead to liver failure in high doses.
“For patients managing chronic pain with an immediate release hydrocodone combination product, an extended release formulation without the risks associated with acetaminophen may be beneficial. Zohydro ER may also be an alternative for people living with chronic pain who have developed opioid tolerance or are experiencing side effects with other long-acting opioids,” the company said in a statement.
Zogenix also announced the formation of an independent “Safe-Use” advisory board to give the company feedback and recommendations regarding the use of Zohydro after its launch. The board will meet regularly to review data about the medication’s prescribing and use.
“This type of voluntary initiative on the part of Zogenix, will allow external, highly experienced specialists, to provide valuable insight and advice about the impact of introducing this new pain treatment to the community and, if needed, to recommend specific actions needed to ensure that the risk of abuse, misuse and diversion is minimized,” said advisory board chairman Jeffrey Gudin, MD, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center in New Jersey.