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Two months after becoming the first drug of its kind approved by the federal government to treat a painful facet of addiction, doctors are calling a new branded drug to cost thousands of times more than a generic drug similar.
The brand name drug, Lucemyra, treats opioid withdrawal and works in a similar manner to the generic, known as clonidine. But the US Food and Drug Administration has given the green light to the brand name drug, lofexidine, which is specifically used to treat opioid withdrawal. Clonidine, on the other hand, is not officially approved for this use, but the generic is frequently used off-label for patients with withdrawal symptoms.
The federal go-ahead seems to have made all the difference when it comes to the price of both drugs. While clonidine costs about $ 1 for a week of treatment, Lucemyra costs $ 1,738.
The price gap was highlighted in a recent blog article in The Medical Letter, peer-reviewed medical journal published by an independent non-profit organization of the same name. The post emphasizes that if the two drugs are different, their mechanisms of action are very similar. So for doctors, the price difference does not make much sense.
"Could one [drug of this kind] really be better than another?" Mark Abramowicz, president of The Medical Letter, asked in his post.
Similar drugs, but only one with FDA approval
Darren Staples / Reuters
Both drugs work by calming the part of the nervous system responsible for the fight or flight response, called the sympathetic nervous system. By suppressing the sympathetic nervous system, lofexidine and clonidine limit opioid withdrawal symptoms such as nausea, vomiting, tremors, and 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 treat opioid withdrawal in lieu of lofexidine because it is inexpensive but that she works the same way. He called the price gap between the two drugs "crazy".
Studies comparing the two drugs suggest that they are also effective in reducing withdrawal symptoms, although lofexidine appears to have a slightly lower impact on blood pressure than clonidine.
"There are three controlled trials comparing the two," writes Abramowicz in The Medical Letter. "They all come to the conclusion that both drugs are almost identical in their effectiveness at reducing symptoms."
But only lofexidine (Lucemyra) is an FDA approved treatment for these symptoms.
Other treatments are almost impossible to obtain
Yet, there are other drugs for opioid withdrawal, such as buprenorphine, methadone and naltrexone. Studies suggest that these drugs work better than clonidine or Lucemyra. The problem is that they are almost impossible to obtain.
Only about half of the private sector treatment programs for opioid use disorder currently offer access to these drugs. And among those who offer it, only one-third of patients actually receive the drug, 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 treatments work. The stigma surrounding drug use and addiction also plays a role. Still other issues include federal and state laws that limit the availability of drugs.
"It's more of a problem of implementation than a fundamental scientific problem," said Kelly J. Clark, president of the American Society of Addictive Medicine, at Business Insider in April, "because that we know what works. "
These roadblocks are part of the reason why drug makers have sought alternative drugs to treat various facets of addiction. The number of deaths due to opioid use disorder continues to climb – opioids have caused nearly 42,000 deaths in 2016 alone.
Mark Pirner is the medical director of clinical research for the company that makes Lucemyra, US WorldMeds. He told Business Insider that these roadblocks were influencing the company's decision to prosecute lofexidine.
Pirner said that he believes that the slight differences between lofexidine and clonidine are important enough to merit the price gap.
"People who have used both know the benefits," he said, adding that clonidine tends to make people feel uncomfortable and "out of the way" , while lofexidine does not.
In addition, Pirner said, most patients will not see this full cost, as most will be paid by insurers.
"From a cost point of view, the market will prove it," Pirner said.
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