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FDA and Opioids: What's Going On Here?

From MedPage Today:

Against the recommendation of its own advisors (who voted 11-2 in December not to approve the drug), the U.S. Food and Drug Administration approved a new high-dose narcotic painkiller, a drug that the FDA concedes has a high risk for abuse and one which was using a method that critics say may give the drug the appearance of greater efficacy.

Zohydro ER will be the first hydrocodone-only opioid, and it will come in doses packing five to 10 times more heroin-like narcotic than traditional hydrocodone products such as Vicodin that combine hydrocodone with over-the-counter pain relievers such as acetaminophen or ibuprofen.

Though the narcotic in Zohydro ER is designed to be released slowly over 12 hours, pleasure seekers will be able to crush it, chew it or mix it with alcohol to unleash its full punch at once. That abuse potential would have been blunted if the FDA required that the drug be formulated with abuse-prevention technology -- a process the FDA has publicly backed, but did not require in this case.

Tthe FDA concluded that the benefits of Zohydro outweighed its risks and that data show it is safe and effective for round-the-clock use. Its label will have prominent warnings about abuse. The label will urge prescribers to monitor patients for addiction or misuse.

But during the FDA advisory committee hearing last December, a company official said an abuse-deterrent formulation of the drug was only in early development and was "several years away from the market."

Friday's approval of Zohydro is the latest action by the agency, which recently has been the target of claims that it is too friendly toward the opioid industry. And it comes follows closely complaints that the FDA had not done enough over the years to curtail the booming overuse of opioids.

The U.S. already consumes 99% of the hydrocodone used in the world.

Posted: 10/29/2013 12:25:00 PM

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FDA Approves Investigational Trials Assessing Cannabidiol for Pediatric Epilepsy

From eNews Park Forest (IL):

The US Food and Drug Administration has approved two clinical trials to assess the efficacy of cannabidiol (CBD), a nonpsychoactive plant cannabinoid, in the treatment of intractable pediatric epilepsy. The two approved trials will take place at New York Medical School and at the University of California at San Francisco.

Cannabidiol has been documented to possess a variety of therapeutic properties in preclinical models, including anti-epileptic activity. Clinical trials have shown the oral administration of CBD to be "safe and well tolerated" in healthy subjects.

Posted: 10/25/2013 12:35:00 PM

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"Unreal" Overdose Spike Has Officials Ready to Fight Opioid Drugs

From NBC10 Philadelphia:

An alarming number of drug overdoses has officials in one Bucks County township gearing up for a fight.

In the past month, 63 people have overdosed in Bensalem, Pa. on opioid drugs like heroin and prescription pain killers that include oxycodone and vicodin says township Director of Public Safety Fred Harran.

While heroin is widely known as a dangerous and severely addictive narcotic that’s long been a target of the war on drugs, Harran says it’s the prescription painkillers that are a bigger source of concern.

Between 80 and 90-percent of the crimes committed in the town are tied in one way to drugs, according to Harran. He says the drug seekers are both a mix of local residents and visitors traveling to the town to get high.

Harran and other public safety officials have been meeting to determine an attack plan to cut down on drug use and availability. The director says he’s not ready to release every detail about the plan, but said the department’s actions would be "groundbreaking."

A new report released on Monday from the Trust for America’s Health found Pennsylvania has the 14th highest rate of drug overdose deaths. The report found the Commonwealth had 15.3 overdose deaths per 100,000 residents in 2010. Most of those deaths involved the use of prescription drugs.

In Philadelphia, city officials have seen what they call a startling spike in addiction rates, deaths and confiscations by police of opioids like prescription pills and heroin.

Nationally, drug overdose is the leading cause of injury death in the United States, according to the Centers for Disease Control and Prevention. Drug overdose deaths have jumped 102-percent from 1999 to 2010 and as of the last reporting in 2010, 60-percent of those deaths were related to pharmaceuticals.

The CDC also found that of the 38,329 overdose deaths in 2010 that involved pharmaceuticals, 75-percent involved some form of opioid.

Deadly drug 'N-bomb' claims teen's life

From WHTM (Harrisburg, PA):

A new designer drug is believed to be responsible for the death of a Cumberland County high school student.

Dauphin County Coroner Graham Hetrick said a 17-year-old Trinity High School student who died from an overdose last month had a drug called "25I-NBOMe" in his system.

A synthetic version of LSD, or acid, 25I-NBOMe is also known by the street names "N-bomb," "251" and "smiles." It is sometimes sold as LSD, unbeknownst to the buyer.

Across the nation, at least six deaths have been linked to its use. The drug currently is unregulated by federal law, but Louisiana, Florida and Virginia have been trying to ban it.

Posted: 10/7/2013 11:16:00 AM

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