- FDA staff says in report Vantrela may not prevent oral abuse
- Teva’s hydrocodone faces FDA advisory panel on Tuesday
Teva Pharmaceutical Industries Ltd.’s hydrocodone painkiller works to deter people who might try to crush the drug and snort or inject it to get high, U.S. regulators said.
The extended-release tablets, called Vantrela ER, showed better resistance to abuse by inhalation and injection than other hydrocodone capsules, Food and Drug Administration staff said in a report released Friday. Yet the data from testing isn’t sufficient to establish that the pain pill would be superior at preventing oral abuse, according to the report.
Agency advisers will meet Tuesday to recommend whether the label on Teva’s painkiller should make abuse-deterrent claims. FDA reviewers typically offer their analysis of clinical trials and any lingering concerns before such meetings.
Pharmaceutical companies have worked to develop abuse-deterrent painkillers over the past several years, particularly as opioid addiction has become epidemic in the U.S. The FDA has approved six pain medications with labels describing the properties that make them difficult for recreational drug users to abuse. Those can include gelling agents, the addition of a drug that interferes with the euphoria linked to abuse, or substances that would make abuse unpleasant, such as a nasal irritant.
Pfizer Inc.’s oxycodone, which the company also wants to label as abuse-deterrent, will face the advisory panel on Wednesday. The Pfizer capsules combine oxycodone with naltrexone, which is used to reverse the effects of opioids.
Teva tested its hydrocodone against other pills, using crushing and grinding mechanisms and by dissolving the pills in solvents such as water or alcohol. While Vantrela ER’s abuse-deterrence properties work better against snorting or injecting, they are only comparable to other extended-release hydrocodone products when abusers use a solvent to extract the opioid from the other ingredients in the pill, FDA staff said in the report.
FDA staff also said that Vantrela ER is superior at deterring abuse compared to immediate-release combination hydrocodone and ibuprofen.
Purdue Pharma also makes an abuse-deterrent hydrocodone called Hysingla, cleared for sale in 2014. Purdue reformulated its OxyContin in 2010 and the FDA determined in 2013 has an increased ability to resist crushing, breaking and dissolution. The agency rejected a similar request from Endo International Plc the same year to label its Opana oxymorphone pain pill as abuse-deterrent because the agency said the crush-resistant features could be manipulated by cutting or chewing.
Zogenix Inc.’s Zohydro was the first approved pure hydrocodone painkiller. Zogenix touted it as an alternative to drugs including Vicodin that mix hydrocodone with less-potent medicines such as acetaminophen. The FDA was attacked by critics for giving a green light to a powerful pain pill that didn’t include abuse-deterrent properties, but the agency said its benefits outweighed its risks. Acetaminophen can damage the liver.
About 20,000 Americans died from overdosing on prescription opioid painkillers in 2014, more than triple the number in 2001, according to the National Institutes of Health. Deaths from heroin, which also is an opioid, rose to 12,000 from 2,000 in the same period.