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Other treatments are nearly impossible to get

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Two months after it became the to treat a painful facet of addiction, doctors are calling out a new branded medication for costing thousands of times more than a similar generic drug.

The branded medication, , treats and works in a way that's similar to the generic, known as clonidine. But the US Food and Drug Administration has given the green light for the branded drug, whose off-brand name is lofexidine, to be used specifically to treat opioid withdrawal. Clonidine, on the other hand, isn't officially approved for that use, but the generic is frequently used off-label for patients with withdrawal symptoms..

The federal green light appears to have made all the difference when it comes to the pricing of the two drugs. While clonidine costs roughly for a week's worth of treatment, Lucemyra costs ,738.

The price gap was pointed out in a recent blog post in The Medical Letter, a peer-reviewed medical journal published by an independent nonprofit of the same name. The post highlights that while the two drugs are different, their mechanisms of action are very similar. So to physicians, the price difference doesn't make a whole lot of sense.

"Could one [drug of this kind] really be that much better than another?" Mark Abramowicz, the president of The Medical Letter, asked in his post.

Similar drugs, but only one with FDA approval

Darren Staples / Reuters Both drugs work by quieting the part of the nervous system responsible for the fight-or-flight response, called the sympathetic nervous system. By subduing the sympathetic nervous system, lofexidine and clonidine both curb opioid withdrawal symptoms like nausea, vomiting, shakiness, and pervasive feelings of panic and depression.

David Juurlink, a professor of medicine at the University of Toronto, told Business Insider that clonidine is frequently used to help treat opioid withdrawal instead of lofexidine because it's inexpensive but works similarly. He called the price gap between the two drugs "crazy."

Studies comparing the two drugs suggest that they are equally effective for cutting withdrawal symptoms, though lofexidine appears to have a slightly lower impact on blood pressure than clonidine does.

"There are three controlled trials comparing the two," Abramowicz wrote in The Medical Letter. "They all come to the conclusion that the two drugs are almost identical in their efficacy in reducing symptoms."

But only lofexidine (Lucemyra) is an FDA-approved treatment for these symptoms.

Other treatments are nearly impossible to get

Still, other drugs for opioid withdrawal exist, like buprenorphine, methadone, and naltrexone. Studies suggest those drugs work better than clonidine or Lucemyra. The problem is they're nearly impossible to get.

Only about half of private-sector treatment programs for opioid use disorder currently offer access to those drugs. And of those that offer it, only one third of patients actually receive the medication, according to a study published in the Journal of Addiction Medicine.

There are many reasons for this lack of access to medication. Some stem from a misconception about how the treatments work. The stigma surrounding drug use and addiction plays a role, too. Still other issues include federal and state laws that restrict the availability of the medications.

"It's more of an implementation problem than a basic science problem," Kelly J. Clark, president of the American Society of Addiction Medicine, told Business Insider in April, "because we know what works."

Those roadblocks are part of the reason drug makers have looked for alternative drug candidates to treat various facets of addiction. The death toll from opioid use disorder continues to climb — opioids claimed roughly 42,000 lives in 2019 alone.

Mark Pirner is the medical director of clinical research for the company that makes Lucemyra, US WorldMeds. He told Business Insider that those roadblocks influenced the company's decision to pursue lofexidine.

Pirner said he believes the slight differences between lofexidine and clonidine are substantial enough to merit the price gap.

"People who've used both know the benefits," he said, adding that clonidine tends to make people feel groggy and "out of it," whereas lofexidine does not.

Plus, Pirner pointed out, most patients won't see that full cost, since it'll be paid by insurers for the most part.

"From a cost perspective, the market will bear it out," Pirner said.






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Date: 18.12.2018, 23:52 / Views: 42271