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Zogenix 10 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

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

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

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

Massachusetts governor’s ban of Zohydro may be unconstitutional

Massachusetts governor Deval Patrick’s banning of the controversial new painkiller Zohydro may be the first time a state has tried to block distribution of an FDA-approved drug and sets the stage for a heated constitutional debate. Last week, Gov. Patrick restricted doctors in Massachusetts from prescribing or dispensing Zohydro, the only pure hydrocodone on the market. The medication was approved by the FDA last fall and was distributed nationwide last month. Gov. Patrick banned the drug in an effort to curb a growing prescription drug abuse epidemic. In response, Zohydro’s maker, Zogenix, filed a lawsuit this week in an attempt ... Read More

Zohydro maker files lawsuit to block Massachusetts governor’s ban

Less than a week after Massachusetts governor Deval Patrick banned the sale of the controversial new potent painkiller Zohydro, the drug’s maker has filed a lawsuit aimed at blocking the governor’s request. Zogenix filed the lawsuit in U.S. District Court in Massachusetts Monday. A hearing was scheduled for Tuesday afternoon. The drug company contends that Gov. Patrick’s order to ban its potent opioid goes against the U.S. Food and Drug Administration (FDA), which approved the drug for marketing last fall. Zohydro hit the market nationwide last month. Gov. Patrick banned the drug as part of an attempt to quell a ... Read More

Legislation aims to revoke FDA’s approval of new opioid Zohydro

A group of lawmakers concerned about health risks and a growing epidemic of prescription drug abuse has introduced legislation to revoke the Food and Drug Administration’s approval of the new, highly potent opioid painkiller Zohydro ER. “I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug. Their refusal to budge forces me to introduce legislation,” Sen. Joe Manchin, D-W.Va., said in a statement. He teamed up with Rep. Stephen Lynch D-Mass, and Rep. Hal Rogers, R-Ky., on the bill. Zohydro ER is the first pure hydrocodone drug to be approved ... Read More

Potent Zohydro painkiller faces more hurdles as it enters market

The fate of the newly approved, potent opioid painkiller Zohydro continues to hang in the balance. The drug is expected to hit the market later this month despite petitions from physician groups, consumer watchdog groups, addiction counseling groups, and even a team of attorneys general urging the Food and Drug Administration (FDA) to rethink its recent approval of the drug. Two senators have also requested an investigation into whether pay-for-play practices played a role in the approval of Zohydro. Now, the painkiller faces another challenge: the makers of OxyContin say they have completed testing of an abuse-resistant version of the ... Read More

Attorneys general ask FDA to rethink its approval of first single-ingredient hydrocodone painkiller

Twenty-eight attorneys general are calling for the removal of powerful new painkiller Zohydro, arguing that the narcotic would only add to the national epidemic of prescription drug abuse. Zohydro, the first and only single-ingredient hydrocodone painkiller approved by the Food and Drug Administration (FDA), was granted clearance by the agency in October. It is an extended release formulation that is considered five to 10 times more potent than hydrocodone combination pill such as Vicodin. The state prosecutors are asking the FDA to either revoke the drug’s approval or require the drug maker Zogenix to change the formulation so that it ... Read More