Pressure is mounting on the US Food and Drug Administration (FDA) to revoke its decision to approve the single-entity extended-release hydrocodone product (Zohydro ER, Zogenix Inc) The drug is expected to hit the market this month.
On March13, Sen. Joe Manchin (D-WV) introduced legislation to withdraw the FDA's approval of Zohydro ER and prohibit the FDA from approving any application for pure hydrocodone bitartrate extended-release capsules unless it is formulated to prevent abuse.
"I have tried reasoning with the FDA, and I've repeatedly requested the agency change its course on this dangerous drug," Manchin said in a statement posted on his Web site. "Their refusal to budge forces me to introduce legislation."
"Because of this painkiller's high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country. The prescription drug abuse epidemic has already damaged and destroyed the lives of far too many individuals and families, and hydrocodone is one of the most abused substances out there. The last thing we need is a drug on the market with 10 times the hydrocodone of Vicodin and Lortab, with the capability of killing an individual in just two tablets," Manchin said.
Rep. Stephen Lynch (D-Mass) and Rep. Hal Rogers (D-Ky) introduced similar legislation aimed keeping Zohydro off the market in the House the same day.
Consumer groups and attorneys general of 29 states and territories have also asked the FDA to consider reversing its approval of Zohydro ER, as reported recently by Medscape Medical News.
The FDA approved Zohydro ER in October 2013 for the management of pain severe enough to require daily, around-the-clock long-term treatment and for which alternative options are inadequate.
The FDA approved the drug over the objection of its own Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2 against approving the powerful opioid painkiller.
Each pill contains significantly more hydrocodone than any similar opioid painkiller currently on the market and is manufactured without an abuse-deterrent formulation.
Manchin said, "Unless this product is reformulated to prevent abuse, I strongly believe Zohydro will only fuel addiction and death in this nation. It must be kept off the market for the well-being of our nation, especially our families and our youth."
Reps. Lynch and Rogers agree. "The burdens of Zohydro ER to the public health outweigh its potential therapeutic benefits," their bill reads. "Given that alternative pain medicines and methods are widely available, approval of Zohydro ER should be withdrawn until such time that there is available a [FDA]-approved abuse deterrent formulation."
On the same day the 2 bills were introduced, FDA Commissioner Margaret Hamburg, MD, defended her agency's decision to approve Zohydro ER, telling Senate lawmakers that the drug fills an "important and unique niche" for treating chronic pain, several media outlets reported.
"The FDA has not had an opportunity to review the proposed legislation," Dr. Hamburg said in a statement to Medscape Medical News. "However, the agency looks forward to continuing to work with Congress on preserving access to medications for patients suffering from pain, while addressing a serious public health problem — the inappropriate use of opioids. These are important and complex issues, which will benefit from full and thoughtful discussion."
According to the Centers for Disease Control and Prevention, the number of drug poisoning deaths involving hydrocodone and other opioid analgesics more than quadrupled from 4030 in 1999 to 16,651 in 2010.
The Drug Enforcement Agency (DEA) estimates hydrocodone tops the list of the most abused prescription drugs in the United States. Earlier this month, the DEA published in the Federal Register a formal proposal to reschedule hydrocodone combination products from Schedule III to Schedule II, a move that would further increase controls on the powerful opioid pain medications.
Last week, Purdue Pharma LP reported positive topline phase 3 results with a once-daily extended-release hydrocodone formulation with abuse-deterrent properties. 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.
If approved, the agent (hydrocodone bitartrate, Purdue Pharma LP) would be the first extended-release hydrocodone product with abuse-deterrent properties, the company said in a statement. The company also has an approved abuse-deterrent formulation of oxycodone (OxyContin).
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Cite this: Bills to Ban Zohydro Introduced in House and Senate - Medscape - Mar 18, 2014.