Maker Of OxyContin Believes Children Are The Future (For Extending Its Patent)

The company that makes OxyContin has a good thing going, with lots of free PR from shows like Intervention and Justified and no exact generic equivalent to undercut its market share. But there are dark clouds on the horizon for the OxyContin brand, as its patent is set to expire in April. Now, in a ploy to extend that patent, the Oxy folks are going through the motions of pretending they actually care whether or not children can take the drug safely.

The Wall Street Journal reports that Connecticut-based Purdue Pharma LP is just now trying to enroll youngsters in a study to test whether or not OxyContin would be safe and helpful to kids ages 6-16 with “moderate to severe” pain. All this is described in documents reportedly filed with the U.S. National Institutes of Health.

Whether or not the study is successful, so long as it passes an FDA review, it would result in a six-month extension on the Oxy patent.

Given that the drug brought in $2.8 billion in sales in 2011, this test is worth at least $1 billion to Purdue.

The move by Purdue is remarkably similar to one attempted two years ago by Pfizer, which sought to extend — no pun intended — the patent on Viagra by saying that a low-dose version of the drug could be helpful to children with a very rare lung disorder.

Both are examples of drug makers exploiting FDA incentives that encourage and reward clinical drug trials. The FDA argues that, because clinical trials rarely include children, it is trying to help provide accurate information to doctors that may prescribe medicine to children that is normally intended for adults. To the drug companies, it’s just an easy way to score a patent extension.

A rep for the company admitted as much when he told the Journal, “These trials are not intended to promote the use of OxyContin in pediatric patients.”

Some doctors aren’t exactly thrilled with the idea that Purdue is planning to test OxyContin — one of the more addictive painkillers on the market — on children with chronic pain conditions.

Meanwhile, Purdue has already begun arguing in court that a 2010 formulation update intended to curb Oxy abuse should rightfully extend the patent through 2025. Obviously, the generic drug makers, who stand to profit when the patent expires, disagree.

OxyContin Trial Planned for Kids [WSJ.com]

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  1. Blueskylaw says:

    “Purdue Pharma LP is just now trying to enroll youngsters in a study to test whether or not OxyContin would be safe and helpful to kids ages 6-16 with “moderate to severe” pain”

    “These trials are not intended to promote the use of OxyContin in pediatric patients.”

    Why are these moves allowed? Purdue Pharma basically admitted they just want to extend the patents and that they are not trying to promote OxyContin use by pediatric patients. That means that this is a money grab and a waste of time, money and resources by the FDA for a study that has no meaning.

  2. CrazyEyed says:

    You bet your ass that pun was intended.

  3. scoosdad says:

    “Whether or not the study is successful, so long as it passes an FDA review, it would result in a six-month extension on the Oxy patent.”

    That’s it? Six months? Hardly seems worth the trouble or the controversy.

    I guess I don’t understand how reducing the existing drug’s strength or encapsulation to allow kids to safely use it qualifies as enough of a change to grant a patent extension. But that’s our patent system for you– broken and badly in need of an overhaul.

    • incident-man stole my avatar says:

      6 months will result in 10’s of millions in profit for Purdue…

    • ChuckECheese says:

      From the RTFA: It will mean another $billion in sales for Purdue Pharma.

    • who? says:

      I only spent 20 seconds searching, so I didn’t find anything more recent, but Purdue make $264 million in profits on Oxycontin in 2006. An extra six months would be worth a cool $130 million or so…

      • dwtomek says:

        Plus, if they can get kids hooked on that crap, that’s a whole new generation to support the already prosperous (for both sides of the aisle) black market. Go big pharma go!

  4. lovemypets00 - You'll need to forgive me, my social filter has cracked. says:

    I have mixed feelings about availability of generic OxyContin. On one hand, people with legitimate pain problems might be able to save money and perhaps pay lower copayments for their meds. On the other hand, I worry the lower cost will make it cheaper for the hillbilly heroin crowd and increase drug addiction rates.

    • MrEvil says:

      Just because a drug goes generic doesn’t necessarily make it easier to obtain. You still have to con a doctor into writing a script. And since Oxy is a DEA schedule medication the DEA can and does question physicians that prescribe the medication “too frequently” Going generic just makes the drug cheaper for the folks that actually need it.

      Going Generic =! Going OTC.

    • Willow16 says:

      This is the kind of thinking that makes doctors hesitant to write prescriptions for pain meds. People who have legitimate reasons to take it most likely can’t get it or must jump through many hoops to get it. I get it – we don’t want people abusing it but there has to be a better way. I had back surgery (double ruptured disc, double laminectomy, permanent nerve damage) and was in excruciating pain. After the surgery, I asked my doctor if I could have a prescription of five to eight percocet pills for a month since I had good days and bad days depending on my level of activity. Nope. Even now, getting a prescription for muscle relaxers for long car rides or for times when I’ll be sitting for long periods of time is difficult. The thing is, if my lower back muscles tighten up too much, my foot will go numb and I won’t be able to walk. I have a very legitimate reason to have a prescription but doctors still will only give me ten at a time and question me when I ask for a refill. Very frustrating.

      • who? says:

        This. I have a neck injury, and about twice a year, I’ll do something and be in excruciating pain. Every single time this happens I have to spend $300 going to urgent care, because they won’t let me have a few pills on hand for the next time it happens. Every time I go to urgent care, I get treated like I’m a drug seeking loser, and they give me 10 pills and tell me to come back if 10 pills doesn’t solve the problem.

        • BurtReynolds says:

          Well you get treated like a meth cook any time you go buy suphredrine these days. As usual the abusers have ruined it for the rest of us.

    • Skyhawk says:

      People need to take responsibility for their own actions.
      No person should have to live with pain because a percentage of the population will always have problems with anything addictive.
      Gambling, drugs, alcohol, etc. There will always be people who become addicted.
      We can’t keep passing laws that punish everyone else, for the behavior of a few.

  5. LorgSkyegon says:

    Anything that encourages doctors to prescribe enough pain medication to those that actually need it is a good thing in my opinion. The feds have gone too far in the drug war and are making it difficult for people who actually have severe chronic pain to get the relief that they need.