Drugmaker submits harder-to-abuse Zohydro to FDA
WASHINGTON (AP) — The maker of the much-debated painkiller Zohydro is seeking approval of a harder-to-abuse version of the drug which, if approved, could replace the currently marketed version of the pill by next spring.
San Diego-based Zogenix said Wednesday that it submitted a Food and Drug Administration application for a new formulation of Zohydro that is designed to be more difficult to snort or inject — two common methods for abusing painkillers. Zogenix expects approval in the first quarter of 2015, which would allow the drugmaker to replace the older version of Zohydro in the second quarter.
Zohydro has been criticized by health advocates, politicians and law enforcement officials since it became the first single-ingredient hydrocodone drug ever approved for U.S. patients last fall. Critics said the FDA should have rejected the drug in its original form, given the ongoing epidemic of prescription painkiller abuse. Deaths linked to the medications have risen to nearly 17,000 annually, more than heroin and cocaine combined.
Despite the attention focused on Zohydro, the extended-release pain medication has not been widely prescribed. In its first six months on the market, U.S. physicians wrote 13,200 prescriptions, according to data tracker IMS Health. Older opioid drugs like Vicodin, OxyContin and similar generic versions are prescribed millions of times per month.
Earlier this year, Zogenix said it created an oversight board of medical, addiction and law enforcement specialists to spot early signs of misuse using data from sources like prescribing statistics and addiction center reports.
Zohydro is part of a group of long-acting opioids designed to deliver relief for patients with around-the-clock pain. The pills and tablets are formulated to slowly release their drug contents over 12 or more hours. But abusers can get a massive, heroin-like high by releasing the entire dose drug at once by chewing, snorting or injecting the pills or tablets.
Zohydro is also working to develop a tablet version of the drug that is resistant to chewing.
Shares of Zogenix Inc. rose 6 cents, or 5.2 percent, to $1.21 in afternoon trading Wednesday.