Washington, DC – After the U.S. Food and Drug Administration (FDA) approved a powerful new opioid painkiller Zohydro recently, even after the agency’s own panel voted against approving the drug, U.S. Senators Kirsten Gillibrand (D-NY), Joe Manchin (D-WV), Dianne Feinstein (D-CA), and Amy Klobuchar (D-MN) requested an explanation from the FDA on why the agency ignored its own panel’s recommendations and called on the FDA to expedite the development of an abuse-deterrent formula that would make the drug tamper-resistant.
In a letter to FDA Commissioner Margaret Hamburg, the Senators wrote, “Given the severity of the prescription drug epidemic, it is irresponsible for FDA to approve a single entity, hydrocodone bitartrate product that does not contain tamper resistant technology. This will only contribute to the rising toll of addiction and death. We ask that you explain the reason FDA ignored the recommendations of the Advisory Committee. Further we ask that FDA work with Zogenix Inc., the manufacturer of Zohydro ER, to rapidly incorporate tamper resistant and abuse deterrent technologies into all commercially available forms of hydrocodone that they manufacture.”
“At a time when communities across New York are facing a growing abuse of prescription painkillers, it is deeply alarming that the powerful drug Zohydro has been approved without abuse-deterrent protections,” said Senator Gillibrand. “This is a giant step backwards and may fuel the prescription drug epidemic. The FDA must take steps to expedite a tamper-resistant drug and limit the widespread abuse of hydrocodone.”
The form of Zohydro that has been approved can easily be crushed, making it more vulnerable to abuse and allowing the drug to be absorbed more quickly. This pure hydrocodone pill, which is manufactured by San Diego-based Zogenix, Inc., is five to ten times more potent than Vicodin.
In New York, opioid overdose deaths have increased 65 percent since 2005. According to the New York City Department of Health and Mental Hygiene, the introduction of abuse-deterrent technologies to oxycodone, another prescription opioid that has been subject to abuse, was responsible for reducing abuse and misuse of oxycodone drugs by 50 percent.
Last year, Gillibrand pushed for stricter measures on hydrocodone-based drugs, urging FDA to reclassify any substance containing hydrocodone from a “Schedule III” to “Schedule II” drug, which would ban patients from automatic refills and would require patients to receive a prescription each time. In October 2013, the FDA announced their new policy to reclassify painkillers that combine hydrocodone with other drugs, including Vicodin to Schedule II.
Senators called for rapid development of abuse-deterrent technologies for Zohydro.
Full text of the Senators’ letter is below:
Dear Commissioner Hamburg,
We are writing to express concern regarding the Food and Drug Administration (FDA) approval of Zohydro Extended Release (ER), a powerful, opioid drug product on October 25, 2013 (NDA 202880). This approval was given despite opposition of the FDA’s own Anesthetic and Analgesic Drug Products Advisory Committee, which voted 11-2 against allowing Zohydro ER to advance in the approval process.
The minutes of the Advisory Committee make clear, “Although the committee agreed that the Applicant met the Agency standards for efficacy and safety, the majority of the committee did not support the approval of this application. The committee agreed that standards for opioid product approval should be raised in light of the current public health concerns of abuse and misuse. The committee stated that the FDA should not approve ER/LA opioids without tamper-resistant or abuse-deterrent formulations, and that additional risk mitigation features should be adopted to strengthen the current ER/LA Opioid Analgesic REMS.”
The rate of prescription pain medication misuse and death by unintentional opioid poisoning (overdose) has increased steadily across the nation. In New York, opioid overdose deaths have increased 65 percent since 2005. West Virginia opioid sales increased 125% between 2001 and 2011, with the state leading the nation in fatalities as a result of drug overdose. Nationally, 23.5 million individuals have used hydrocodone for non-medical purposes. According to the New York City Department of Health and Mental Hygiene, the introduction of abuse-deterrent technologies to oxycodone, another prescription opioid that has been subject to abuse, was responsible for reducing abuse and misuse of oxycodone drugs by 50 percent. Given the severity of the prescription drug epidemic, it is irresponsible for FDA to approve a single entity, hydrocodone bitartrate product that does not contain tamper resistant technology. This will only contribute to the rising toll of addiction and death.
On January 25, 2013, the FDA’s own Drug Safety and Risk Management Advisory Committee voted 19-10 to reclassify hydrocodone. Subsequently, the FDA announced on October 24, 2013, their recommendation to reschedule the addictive drug from a Schedule III to a Schedule II opioid. The recommendation made by the FDA exhibits their awareness to the addictive nature of hydrocodone and the danger it causes to those who abuse the drug.
We ask that you explain the reason FDA ignored the recommendations of the Advisory Committee. Further, we ask that FDA work with Zogenix Inc., the manufacturer of Zohydro ER, to rapidly incorporate tamper resistant and abuse deterrent technologies into all commercially available forms of hydrocodone that they manufacture.