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The state of New Hampshire has filed suit against OxyContin manufacturer Purdue Pharma for its alleged role in helping create the opioid epidemic afflicting the nation. New Hampshire, which President Donald Trump recently dubbed a “drug-infested den,” is number two in the country for opioid…

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sued opioid distributors over its drug crisis, the first such case brought in a tribal court.

Back in 2007, Purdue was fined $634 million by the federal government for charges related to its “misbranding” of OxyContin. At that time, it was the largest fine ever levied against an American corporation. Purdue also reached a $19.5 million settlement with 26 states and the District of Columbia. New Hampshire wasn’t among those states that benefitted from the Purdue settlement.

Most recently, in 2015, the drugmaker agreed to pay $24 million to resolve a lawsuit by the state of Kentucky.

“To defeat the epidemic, we must stop creating new users, and part of that is making sure these highly addictive and dangerous drugs are marketed truthfully and without deception and in such a way as not to minimize addiction risks or overstate benefits to patients,” said Ann Rice, the state’s Deputy Attorney General. “New Hampshire continues to experience a severe opioid epidemic. Last year alone nearly 500 overdose deaths occurred – almost ten times more than in 2000.”

Purdue’s reply

Purdue provided a response to the New Hampshire lawsuit in a statement to the media:

“While we vigorously deny the allegations, we share New Hampshire officials’ concerns about the opioid crisis, and we are committed to working collaboratively to find solutions. OxyContin accounts for less than 2 percent of the opioid analgesic prescription market nationally, but we are an industry leader in the development of abuse-deterrent technology, advocating for the use of prescription drug monitoring programs and supporting access to Naloxone — all important components for combating the opioid crisis.”

The rash of litigation related to the opioid epidemic may not be over. According to a June report, some 20 state attorneys general have announced their own investigations into the roles played by pharmaceutical companies involved in opioid manufacturing and distribution.

If you or someone you care for is experiencing dependence or addiction to opioids, or any drugs or alcohol, don’t wait until it’s too late. Do something about it now. Call Novus today.

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New FDA Commissioner Scott Gottlieb, MD, says the agency wants to know whether abuse-deterrent prescription opioids "are having their intended impact on limiting abuse and helping to curb the epidemic." To help get a meaningful answer, Gottlieb has called a public meeting for July 10 and 11,…

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issues paper outlining existing regulatory and public health challenges.

As we reported two weeks ago, the new Commissioner told his first staff meeting that “our greatest immediate challenge is the problem of opioid abuse.” This was followed by the news a week later that the FDA has asked for an abuse-deterrent prescription painkiller, Opana ER, to be taken off the market because it’s been so widely abused.

“Opioid formulations with properties designed to deter abuse are not abuse-proof or addiction-proof,” Gottlieb said in a lengthy statement about expanding the FDA’s role in combating the opioid epidemic. “These drugs can still be abused, particularly orally, and their use can still lead to new addiction.”

However, the Commissioner said, these new formulations “may hold promise” as part of a broad effort to reduce abuse.

“We recognize there is a gap in our understanding of whether these products result in a real world, meaningful decrease in the frequency and patterns of opioid misuse and abuse,” he said. “One thing is clear: We need better scientific information to understand how to optimize our assessment of abuse deterrent formulations.”

In his statement, Gottlieb said that “everyone at the FDA is committed to focusing on all aspects of the epidemic.” As part of this program, a steering committee is being formed to examine “additional regulatory and policy actions to combat this crisis” that can reduce the number of new cases of addiction.

The FDA has just published a paper, FDA Facts: Abuse-Deterrent Opioid Medications, that details the agency’s strong support for abuse deterrence formulations. It says that opioids with abuse-deterrent properties are, as Gottlieb says, “not abuse-proof.” But the agency points out that they are “a step toward products that will help reduce abuse.”

The agency “fully supports efforts to better understand the impact of these products in the real-world setting and develop innovative formulations that have the potential to make abuse of these products more difficult or less rewarding,” the paper says. “The FDA is working with many drug makers to support advancements in this area and help drug makers navigate the regulatory path to market as quickly as possible. In working with industry, the FDA is taking a flexible, adaptive approach to the evaluation and labeling of potentially AD products.”

Here’s a list of the currently approved brand-name abuse-deterrent prescription opioids on the market. No generic versions have yet been approved for abuse-deterrent labeling:

The FDA has approved the following opioids with labeling describing AD properties consistent with the FDA’s Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling:

  • OxyContin – oxycodone, Purdue Pharma
  • Targiniq ER – oxycodone and naloxone, Purdue Pharma
  • Embeda – morphine and naltrexone, Pfizer Inc.
  • Hysingla ER – hydrocodone, Purdue Pharma
  • MorphaBond – morphine, Daiichi Sankyo, Inc.
  • Xtampza ER – oxycodone, Collegium Pharmaceutical Inc
  • Troxyca ER – oxycodone and naltrexone, Pfizer Inc.
  • Arymo ER – morphine, Egalet Corp.
  • Vantrela ER – hydrocodone, Teva Pharm.
  • RoxyBond  – oxycodone, Inspirion

We can certainly see the popularity of oxycodone – half of the 10 approved formulations are built around that drug. Three are morphine and two are hydrocodone. Three are designed with the antagonists naloxone or naltrexone, the rest with some sort of crush and dissolve resistance.

It does look like the FDA is working hard to be responsive to the opioid epidemic.  Meanwhile we are working hard to help those that want to end their dependency on opioids.

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Back in the early days of the opioid epidemic, few people if any had the idea that the opioid painkiller OxyContin was going to precipitate the tsunami of addictions and overdose deaths that continues today across America. It was the late '90s and early 2000s, a heady time for OxyContin maker…

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Back in 2001, OxyContin was seen as the prime force driving the fledgling prescription opioid epidemic across America. In West Virginia, addictions and overdose deaths had reached unprecedented levels. And oxycodone - the active ingredient in Purdue Pharma's extended-release painkiller OxyContin -…

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A blockbuster investigative report in the Los Angeles Times recently says Purdue Pharma knew about illegal sales of its opioid painkiller OxyContin to Los Angeles drug dealers, and failed to report it to authorities. The highly addictive and potentially lethal painkiller OxyContin, essentially…

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Novus is the best way to get your life back as painlessly as possible.

Call to speak to one of our experienced & caring detox advisors today!

It’s okay to share your Tylenol or Advil with a friend or family member, but it’s definitely not okay to share your Vicodin, Percocet or OxyContin or other extra painkillers. Tylenols are OTC – over-the-counter drugs – and they’re approved for everyone. But opioids like OxyContin are…

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All the noise we keep hearing about “ending the failed war on drugs” and decriminalizing drugs as the solution to the addiction epidemic is just that – so much noise. In fact, decriminalization doesn’t guarantee less drug use and addiction to illicit drugs like heroin and cocaine and…

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A mom and dad in Philadelphia who lost their son to a heroin overdose have gathered nearly 40,000 signatures on a petition on the popular moveon.org petition website. Cris and Valerie Fiore’s petition calls for amendments to the Affordable Health Care Act to provide longer drug rehabilitation…

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Novus is the best way to get your life back as painlessly as possible.

Call to speak to one of our experienced & caring detox advisors today!

The FDA has said no-go to Purdue Pharma's plan to bring a new immediate-release oxycodone painkiller to market. But the same panelists have approved an extended-release oxycodone painkiller from Collegium Pharmaceutical. Purdue's new painkiller, to be called Avridi if approved, was planned as…

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Two very concerned politicians, from two of the country’s hardest-hit opioid-addiction states, Kentucky and Vermont, are calling the FDA’s recent approval of OxyContin for kids reckless, shameful, disgusting and outrageous. “I am disgusted by the Food and Drug Administration’s (FDA) recent…

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