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Zohydro 19 articles

FDA releases guidelines for abuse-deterrent versions of opioids

Eighteen months after the Food and Drug Administration (FDA) approved Zogenix Inc.’s powerful opioid painkiller Zyhydro despite abuse concerns from consumer groups and lawmakers, the agency has finalized its guidance urging drug makers to devise abuse-deterrent versions of opioids as they move forward. The new formulations of opioids – some of which have already hit the market – are manufactured in a way that prevents them from being crushed and injected or snorted, which many of these painkillers are for a stronger, more intense high, contributing to the country’s prescription drug abuse epidemic. The FDA guidance informs drug makers of ... Read More

FDA approves new formulation of controversial opioid painkiller Zohydro

Drugmaker Zogenix Inc., received Food and Drug Administration (FDA) approval for a new formulation of its highly controversial painkiller Zohydro. The powerful opioid is designed to be more difficult to abuse, though the approval of the medication requires the drug maker to conduct studies to back up that claim. People who abuse opioids, in particular extended release versions, typically crush or dissolve them in liquid to be snorted or injected to produce a more intense high than simply swallowing the pills. Makers of opioid drugs, in an attempt to curb the growing prescription drug abuse and misuse epidemic, have begun ... Read More

New warnings added to label of potent painkiller Zohydro ER

Just months after the new potent painkiller Zohydro ER hit the market amid a slurry of controversy, a long list of new warnings including black box warnings, have been added to the opioid’s safety label. Zohydro, made by Zogenix, is the first pure hydrocodone to be approved in the United States. Hydrocodone is a potent opioid painkiller that is already marketed in combination with other painkillers such as with acetaminophen in the drug Vicodin. The FDA approved Zohydro under the premise that people with chronic pain need more treatment options. Also, the combination hydrocodone with acetaminophen puts patients at risk ... Read More

Anti-addiction groups call for FDA chief’s resignation amid prescription drug abuse epidemic

Frustrated by the Food and Drug Administration’s approval of potent opioid medications during a nationwide epidemic of prescription drug abuse, anti-addiction activists are calling for the resignation of the agency’s top official. More than a dozen groups have banded together and are appealing to the Obama administration to replace FDA Commissioner Dr. Margaret Hamburg, who has headed up the agency since 2009. Activists have been vocal about their disappointment with the agency for its approval of Zohydro, the only single-ingredient hydrocodone on the market. Hydrocodone is in a class of narcotics known as opioids, which are known for their euphoric effects. ... Read More

FDA approves oxycodone combination drug that resists abuse

A powerful combination opioid painkiller whose euphoric effects can be rendered inactive if the drug is tampered with has been approved by the Food and Drug Administration (FDA). The drug’s formulation aligns with the agency’s commitment to combat the misuse and abuse of opioids. “The development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Dr. Sharon Hertz, deputy director of the division of anesthesia, analgesia, and addiction products in the FDA’s Center for Drug Evaluation and Research, said in an news release. Targiniq ... Read More

Abuse-resistant version of opioid Zohydro could hit the market soon

Pharmaceutical company Zogenix is hoping to get a tamper-resistant formulation of its powerful opioid Zohydro reviewed by drug regulators this fall and, if approved, begin marketing it by early next year. Zohydro is a pure hydrocodone painkiller which was approved by the Food and Drug Administration (FDA) last fall and hit the market earlier this year amid much controversy. Medical groups and anti-abuse organizations teamed up to petition the FDA to reconsider its approval of Zohydro, and several attorneys general joined the fight arguing that allowing another powerful painkiller on the market would only exacerbate the prescription drug abuse epidemic ... Read More

City of Chicago files lawsuit accusing drug companies of deceptively marketing addictive painkillers

In the latest battle against prescription drug abuse, the City of Chicago has filed a lawsuit against five drug companies alleging they engaged in deceptive marketing practices for their highly addictive painkillers to reel in extra profit. The lawsuit, filed this week in Cook County Circuit Court, claims the pharmaceutical companies pushed long-term use of their powerful opioids to treat non-cancer pain, which was false, misleading and “unsupported by science.” The lawsuit comes just one month after two California counties filed a similar lawsuit against the same five drug companies – Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, Actavis, Endo ... Read More

FDA panel slated to review powerful new opioid painkiller

Just weeks after the Food and Drug Administration (FDA) refused to take the advice of medical doctors, anti-drug abuse groups, and several attorneys general to reconsider its approval of the powerful new opioid Zohydro, another drug company announced that the agency has agreed to review its investigational extended-release oral formulation of the same narcotic plus acetaminophen. Critics warned the FDA that approving another powerful opioid would only fuel an already growing epidemic of prescription drug abuse. Opioids, which include the medications morphine and oxycodone, are the most abused prescription drug in the United States. Drug company Mallinckrodt is seeking approval ... Read More

FDA panel rejects new opioid painkiller combining morphine, oxycodone

A Food and Drug Administration (FDA) advisory panel has voted unanimously not to recommend the approval of a powerful new prescription painkiller designed to deliver faster relief with fewer side effects. Moxduo is the first drug to combine morphine and oxycodone in one capsule. It is intended to treat moderate to severe pain, such as that associated with accidents and major surgery. Panel members said the drug’s developer QRxPharma did not adequately prove that Moxduo provides better pain relief than morphine or oxycodone alone, nor that the drug is less likely to cause potentially fatal respiratory depression compared to its ... Read More

Federal judge blocks Massachusetts ban of new painkiller Zohydro

Drug maker Zogenix Inc., won another battle in its war to get its controversial painkiller Zohydro on the market. This week, a Massachusetts federal judge blocked plans by Massachusetts Gov. Deval Patrick to ban prescriptions and sales of the newly approved narcotic in the state in an attempt to curb a growing trend of prescription drug abuse. Zogenix filed a lawsuit alleging the move was unconstitutional. U.S. District Judge Rya Zobel ruled that the ban conflicted with federal laws, which take precedence against state laws when the two are in conflict. The U.S. Food and Drug Administration (FDA) approved Zohydro ... Read More