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An effort to get Ecstasy FDA-approved is moving right along

From Tech Insider:

After veteran Tony Macie came back from Iraq in 2007, he was diagnosed with post traumatic stress disorder (PTSD).

Macie went to the VA "on and off" and tried the standard therapy.

"And then I kind of just fell off the radar, secluded, and did my own thing and got really dependent on a lot of the meds," Macie explains in a video by the Multidisciplinary Association for Psychedelic Studies (MAPS).

The retired sergeant then became part of a clinical trial organized by MAPS that was testing an unusual substance in an attempt to heal people with who hadn't responded to traditional therapies for PTSD.

That substance, MDMA (commonly referred to as "Molly"), is the pure form of the illegal party drug known as ecstasy. (Most non-research substances that are sold as ecstasy or Molly are not actually pure MDMA and can be significantly more dangerous.) The trial pairs MDMA with psychotherapy.

One of the early studies conducted by MAPS showed that 83% of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits stuck.

Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials — the second in the three sets of human trials required before the Food and Drug Administration (FDA) will consider a new drug for approval.

"Phase 3 starts around 2017, and it will take four to five years to finish. So that will put it at early 2021 for FDA approval."

Posted: 3/31/2016 3:26:00 PM

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Heroin overdoses will now be considered homicides, coroner says

From PennLive:

Drug deaths in Lycoming County attributed to an overdose of heroin now are ruled homicides.

Coroner Charles E. Kiessling said Wednesday it is time to stop dancing around the issue and "call it what it is."

He now lists homicide as the manner of death on death certificates in cases where heroin has been determined to be the cause.

"If you are selling heroin to someone and they die, isn't that homicide?" he asked.

Calling it accidental down plays the severity of the situation, he said, noting there were approximately two dozen drug overdose deaths in the county last year.

The National Association of Medical Examiners says coroners have the discretion to call overdose deaths homicide or accidental, she said. They meet the definition of death at the hands of another, she said.

Posted: 3/28/2016 9:17:00 AM

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Heroin Epidemic Is Yielding to a Deadlier Cousin: Fentanyl

From The New York Times:

Fentanyl, which looks like heroin, is a powerful synthetic painkiller that has been laced into heroin but is increasingly being sold by itself — often without the user’s knowledge. It is up to 50 times more powerful than heroin and up to 100 times more potent than morphine. A tiny bit can be fatal.

In some areas in New England, fentanyl is now killing more people than heroin. In New Hampshire, fentanyl alone killed 158 people last year; heroin killed 32. (Fentanyl was a factor in an additional 120 deaths; heroin contributed to an additional 56.)

Fentanyl represents the latest wave of a rolling drug epidemic that has been fueled by prescription painkillers, as addicts continue to seek higher highs and cheaper fixes.

Nationally, the total number of fentanyl drug seizures reported in 2014 by forensic laboratories jumped to 4,585, from 618 in 2012. More than 80 percent of the seizures in 2014 were concentrated in 10 states: Ohio, followed by Massachusetts, Pennsylvania, Maryland, New Jersey, Kentucky, Virginia, Florida, New Hampshire and Indiana.

It was only last March that the Drug Enforcement Administration issued a nationwide alert about fentanyl, saying that overdoses were “occurring at an alarming rate throughout the United States and represent a significant threat to public health and safety.”

Its chief characteristic is that it is fast acting.

Joanne Peterson, executive director of Learn to Cope, a statewide support network for families involved with addiction, said fentanyl works so quickly that there is often little time to administer naloxone, which reverses the effects of an overdose.

“At least with heroin, there is a chance that if someone relapses, they can get back into recovery,” she said. But with fentanyl, she said, it is only a matter of moments before an addict can be dead.

Posted: 3/28/2016 9:05:00 AM

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