As those in pharmacy technology industry likely know, abuse is a major problem when it comes prescription painkillers. With misuse levels rising parallel to narcotic painkiller sales, federal health regulators have received much pressure to institute new safeguards.1
In response, the Food and Drug Administration recently approved a new hydrocodone tablet designed to help limit abuse.
Purdue Pharma’s Hysingla ER (hydrocodone bitartrate) is an extended-release tablet used to treat pain severe enough to require daily, long-term opioid treatment that can’t be mitigated by other pain medications. The agency said the tablet is difficult to crush, break or dissolve, making it harder for abusers to snort or inject it.
Pharmaceutical experts are hopeful that if effective, Hysingla could help usher in a new era of regulations on narcotic painkillers. The new drug is only the fourth drug ever approved by the agency with claims that it discourages abuse and tampering. The agency said that the drug is not approved for “as needed pain relief.”2
The Associated Press pointed out that Purdue Pharma’s new drug poses a commercial threat to Zogenix’s hotly debated drug Zohydro, a twice-a-day hydrocodone tablet approved by the FDA last year.1 Zohydro’s approval sparked a wildfire of criticism from elected officials, anti-addiction groups and law enforcement, stating that the pill should have been changed to reduce abuse. FDA officials said they will compare rates of abuse and misuse between Hysingla and Zohdryo.
“If we determine that the drug is no longer shown to be safe and effective the FDA can initiate proceedings to remove that drug from the market,” Dr. Douglas Throckmorton, a deputy director with the FDA’s drug center, told the Associated Press.1
San Diego-based Zogenix is in the middle of creating its own harder-to-abuse version of Zohdyro, which, if approved, could replace the current version.
Hydrocodone, which many might recognize by its brand name Vicodin, is a potent opioid painkiller that has been associated with a rise in dangerous addictions nationwide. The Centers for Disease Control and Prevention reported there is a “growing, deadly epidemic of prescription painkiller abuse” – roughly 75 percent of drug overdoses are caused by prescription painkillers.3 This massive surge in overdoses in the U.S. coincides with a 300 percent increase in the sale of these prescription painkillers since 1999 .
According to the National Institutes of Health, prescription and over-the-counter drugs are the most commonly abused substances by Americans ages 14 and older (behind marijuana and alcohol).4 Besides hydrocodone, opioids include fentanyl (Duragesic®), oxycodone (OxyContin®), oxymorphone (Opana®), propoxyphene (Darvon®), hydromorphone (Dilaudid®), meperidine (Demerol®) and diphenoxylate (Lomotil®).
Although the “abuse-resistant” drug passed, the agency is receiving some backlash for not bringing the new drug before a public advisory meeting. Last year, the FDA’s approval was also criticized, partly because it came despite a 11-2 vote against the drug by its outside experts.1
“Precisely because the approval of opioids is so controversial the FDA is bypassing its advisory committee meetings,” Dr. Andrew Kolodny, a psychiatrist who specializes in addiction treatment and leads the group Physicians for Responsible Opioid Prescribing, told the Associated Press.1
Kolodny also voiced concerns that because the maximum dose per pill 120 milligrams of hydrocodone – more than twice the dosage contained in a 50-milligram pill of Zohdyro – Hysingla has the potential to be more dangerous than Zohydro. 1
Pharmacy technology professionals will have to stay tuned for further updates on the two drugs.
1Perrone, M. (2014, November 20). FDA Approves New, Hard-to-Abuse Hydrocodone Pill. Retrieved November 25, 2014, from http://abcnews.go.com/Business/wireStory/fda-approves-hard-abuse-hydrocodone-pill-27057872
2FDA Approves ‘Abuse-Resistant’ Narcotic Painkiller. (2014, November 20). Retrieved November 25, 2014, from http://consumer.healthday.com/mental-health-information-25/addiction-news-6/fda-approves-abuse-resistant-narcotic-painkiller-693976.html
3Policy Impact: Prescription Painkiller Overdoses. (2013, January 1). Retrieved November 25, 2014, from http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
4Prescription Drugs & Cold Medicines. (2014, July 1). Retrieved November 25, 2014, fromhttp://www.drugabuse.gov/drugs-abuse/prescription-drugs-cold-medicines