As the number of opioid overdose deaths in the United States continue to climb, anti-addiction groups are calling for the FDA Commissioner Dr. Margaret Hamburg to step down.
The National Coalition Against Prescription Drug Abuse and Physicians for Responsible Opioid Prescribing, among others, sent a letter addressed to Health and Human Services Secretary Sylvia Burwell, who oversees the FDA and other health agencies on Wednesday.
The letter asks the Obama administration to replace Dr. Hamburg, who has been the commissioner since 2009.
Some of the controversy has been tied to the U.S. Food and Drug Administration's recent approval of Zohydro ER (hydrocodone bitartrate extended-release capsules), a new painkiller containing the opioid hydrocodone. The drug 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."(Taken from its prescribing information, indications section). It is intended as an option for patients with severe, chronic pain, for whom other treatments have not been effective.
Zohydro ER is the first drug that is purely hydrocodone (not mixed with acetaminophen) to be approved by the FDA. Other popular drugs that contain opioids, like Vicodin and Loratab, combine hydrocodone with acetaminophen. Zohydro ER is manufactured by Zogenix, Inc. based in San Diego, California.
A powerful opioid
Zohydro ER is a therapeutic pain reliever, indicated for use by patients who have tried other painkillers with no relief. It is designed to release into the body over a 12-hour time period, and its highest dose is 50 mg, which contains up to 5 times more hydrocodone than any other drug available.
Proponents of the new drug applaud the availability of a pure, extended release opioid pain reliever that is not combined with any other medication such as acetaminophen, citing the high incidence of liver failure associated with high doses of acetaminophen. They say doctors need to have this choice available to them for their patients who are suffering with severe pain.
Clinical research regarding the efficacy of Zohydro ER involved 500 people who suffer from chronic lower back pain. The research concluded that Zohydro ER displayed significant improvement in pain compared to placebo.
Addiction experts, however, are concerned the new drug will kick off a brand new opioid overdose epidemic. They worry addicts will crush and snort the drug because it does not have an anti-crush technology like Oxycontin does. The drug also contains a higher dose of hydrocodone than Oxycontin does.
Under the Controlled Substance Act, Zohydro ER is considered a Schedule II drug. All Schedule II drugs must be prescribed by a physician, and there are no refills available for Zohydro ER.
Clinical research regarding the safety of Zohydro ER involved more than 1,100 individuals suffering from chronic pain.
Updated labeling requirements
Zohydro ER is the first opioid to receive new, updated labeling that abides by the FDA's labeling requirements for all extended release opioids.
Safety warnings and the appropriate use of the drug will be much clearer to both the physician and the patient.
- "Zohydro ER (Hydrocodone Bitartrate) Extended-Release Capsules." www.zogenix.com.
- "Press Announcements - FDA Approves Extended-Release, Single-Entity Hydrocodone Product." www.fda.gov.
- "Amid Zohydro Controversy, Teva, Purdue and Pfizer Race Ahead with New Pain Drugs - FierceBiotech." www.fiercebiotech.com.
- "Zohydro: Why This New Painkiller Could Spark Another Addiction Epidemic." www.foxnews.com.