Wednesday, October 28, 2020

Jennifer Mittler-Lee's COLUMN

Purdue Reformulated OxyContin to Reduce Abuse — Did They Succeed?

After years of analyzing the data, the results have returned…

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Her story began innocently — a complaint of severe abdominal pain.

Having attempted multiple ways to obtain relief, she finally experienced a reduction in her discomfort from a miracle drug recommended by a friend.

Fourteen years later, this 44-year-old mother of three still relied on the medication. The pain she no longer felt, what remained was an intense craving for the drug. Many times she tried to quit, but each time her willpower failed.

She turned to alcohol.

Her health deteriorated.

Without the drug, she found herself unable to sleep, eat, or relax. She consumed increasingly larger quantities of the drug to achieve the same euphoric effect.

The miracle drug? Laudanum, an early form of opium.

The year? 1866.

The purpose of the above case study is to illustrate not only how long our society has grappled with opioid abuse, but also to highlight how little we have changed.

Bottle of Laudanum/Cydone / Public domain, Wikimedia Commons

A star is born

In 1996, Purdue Pharmaceuticals released OxyContin. The drug’s generic form, oxycodone, was discovered back in 1916 and was originally intended to treat acute, moderate to severe pain.

Acute is the keyword here, meaning short-term.

Purdue realized their oxycodone brand needed to stand-out. Theirs was simply an extended-released version targeted for chronic pain relief.

However, OxyContin was neither superior to old-fashioned immediate-release oxycodone, a cheaper generic, nor did it offer any advantage over other opioids like morphine.

Purdue dipped deep into their pockets and emerged with a masterful marketing scheme. The timing was perfect, with new legislation being pushed to ease public access to opioids for chronic pain.

Company profits grew from $48 million to over $1 billion in just four years.

By 2004, OxyContin became one of the top drugs of abuse, beating out fentanyl, methadone, and hydrocodone.

Interestingly, Purdue sponsored the study that revealed this data.

Time to act

Purdue had no one to blame but itself. The unprecedented amount of money spent promoting OxyContin and the fact that areas that had first access to the drug also had the highest incidences of abuse spoke volumes.

The company backpedaled and introduced an abuse-deterrent formulation in 2010.

Abuse-deterrent formulations were nothing new. They aimed to prevent or to make it harder to alter a drug to obtain feelings of euphoria or reward.

Manufacturers had an arsenal of tricks to choose from.

For example, one of the oldest abuse-deterrent systems was to combine the opioid with an antagonist drug that would reduce euphoria.

Purdue chose the physical route. They redesigned OxyContin to make it more difficult to crush.

Users had long realized that smashing an extended-release product removed the delay, in effect creating a bullet, the entire dose released at once.

In addition to being crush-resistant, Purdue’s new design resulted in the tablet transforming into a thick gel when soaked in water. This, they hoped, would prevent the dissolution of the drug for injection.

Why the system failed

OxyContin’s new formulation worked very well at preventing abusers from snorting, inhaling, or injecting an altered version of the drug.

However, it did nothing to combat the main route of abuse — swallowing the tablet whole as intended.

An FDA panel recently reviewed post-marketing studies for the “new and improved” OxyContin.

The good news

One study looked at over 60,000 patients admitted to opioid abuse programs and found a 50% reduction in self-reporting of OxyContin abuse by snorting or injection.

Also, a review of calls to poison control centers showed a reduced number regarding intentional OxyContin overdose or misuse.

Boiling up heroin/Author/Photographer: Hendrike (2001)/ Wikimedia Commons

But…

Another study looked at which alternatives abusers sought out. Over 20% of respondents claimed to have beaten the tamper-resistant system, while another group, nearly 60%, turned to other drugs, namely heroin.

Why heroin?

As one person stated, “Most people that I know don’t use OxyContin to get high anymore. They have moved on to heroin [because] it is easier to use, much cheaper, and easily available.”

Addressing the crisis

Naturally, the new formulation does nothing to address the nation’s current opioid crisis. Nor does it provide help for those who have become addicted to the drug over years of prescribed use.

The CDC estimates over 60% of drug overdose deaths were due to opioids, and nearly 2 million Americans struggle with dependence on this class of drugs. The vast majority of these are patients who began taking an opioid for acute pain.

The studies found the risk of dependence increased with the duration of time spent on these prescriptions and skyrocketed if a controlled-release product, like OxyContin, was prescribed.

Finding the solutions to these problems will take much more effort, education, and most importantly, the desire of those at the top to institute a change.

It will not be easy, but we owe it to ourselves as a compassionate nation to at least try.

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Jennifer Mittler-Lee B.S. Pharmahttps://medium.com/@jrmittle

I am a pharmacist with over 20 years in the industry. I have worked both retail and hospital and have been known to frequent the nightshift. As a pharmacist, I see how medical jargon confuses people. I like to write healthcare articles in a casual manner in order to connect. Find me on Medium @jrmittle

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Jennifer Mittler-Lee's Column

I am a pharmacist with over 20 years in the industry. I have worked both retail and hospital and have been known to frequent the night shift. As a pharmacist, I see how medical jargon confuses people. I like to write healthcare articles in a casual manner in order to connect.

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