WASHINGTON – Zogenix Inc. has received U.S. approval for a new formulation of its much-debated painkiller Zohydro that is intended to be harder to abuse, though the company is still working on studies needed to promote that claim.
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The Food and Drug Administration late Friday approved new Zohydro Extended Release capsules which are designed to form a thick gel when crushed or dissolved in liquid. People who abuse prescription painkillers typically crush or dissolve them for snorting or injecting. Zogenix said it will replace the currently available version of the drug with the new formulation during the second quarter of the year.
Despite the new design, Zohydro's label will not yet carry any claims that the drug is more difficult to abuse. The FDA requires drugmakers to submit clinical data demonstrating abuse-deterrent properties before promoting them to doctors or patients.
Stephen Farr, president of Zogenix, said in a statement that the company is "committed to completing the ongoing studies to seek additional changes in the product label relating to abuse-deterrent properties by the end of the year,"
Zohydro's initial approval in October 2013 touched off a national debate about prescription drug abuse. Health advocates, politicians and law enforcement criticized FDA's approval of the drug in its original form — which did not contain any anti-abuse properties — saying it would add to 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.
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. The active ingredient in Zohydro is hydrocodone, one of the most widely-abused opioids in the U.S.
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Doctors prescribe opioids for a range of ailments, from post-surgical pain to arthritis and migraines. But medical experts disagree over the appropriate role of opioids in treating pain, with some arguing that they should only be used for the most severe cases, such as cancer pain or end-of-life care.
Currently only four drugs contain FDA-approved labeling claims that they can make abuse more difficult: three from Purdue Pharma and one from Pfizer.
In November, Purdue Pharma received FDA approval for its own long-acting version of hydrocodone that is designed to thwart abuse via chewing, crushing, snorting or injecting. The FDA said the tablets are difficult to crush, break or dissolve.