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The FDA May Block Latest Opioid Addiction Drug from Reaching Consumers


The opioid epidemic continues to wreak havoc across much of the U.S., claiming over 130 lives every day. The addictive nature of opioids, including prescription painkillers and illegal opiates like heroin, is one of the driving forces behind the epidemic as patients continue relying on these drugs long after their treatments have ended. According to the CDC, around 21% to 29% of patients misuse opioids prescribed for chronic pain.

At hospitals and treatment centers across the country, nurses regularly treat and deal with patients struggling with an addiction to opioids. Using addiction treatment medication is one of the best ways to break the addiction cycle and prevent opioid-related deaths.

In the midst of this ongoing crisis, the Food and Drug Administration has just announced that it may block a new addiction drug from reaching the market. Learn why the FDA may block the drug and how this decision could affect those struggling with an addiction to opioids.

Why the FDA May Block the Latest Addiction Drug

The latest addiction drug, known as Brixadi, is a long-acting buprenorphine that patients inject once a month to help with addiction. A buprenorphine is an opiate that helps relieve pain without the high that comes with opioids, while blocking cravings associated with addiction.

However, a competing addiction drug known as Sublocade, which is also a buprenorphine, has been on the market since 2017. If you’re familiar with the nuances of the pharmaceutical industry, you might recall that new drugs are granted three years of exclusive access to U.S. markets. This allows the maker of the drug to recoup its initial investment. After this initial three-year period, competitors can introduce their own versions of the drug into the market, bolstering competition and lowering prices for consumers.

With 2020 right around the corner, Sublocade’s three-year period is almost up. But that doesn’t mean Brixadi will be on the market any time soon. Indivior, the company that manufactures Sublocade, created its first buprenorphine-based drug back in the 1990s. At the time, addiction wasn’t the epidemic it is today.

To make sure the company made its money back, Indivior asked the FDA to give the company what’s known as “orphan drug” status. Orphan drugs are those that treat illnesses affecting fewer than 200,000 people a year. The FDA gives orphan drugs seven years of exclusive access to U.S. markets instead of the traditional three, which gives the manufacturer more time to recoup its initial investment.

Little did the FDA know that addiction would become a mainstream concern twenty five years down the line. When the FDA handed orphan drug status to Indivior back in the 1990s, it applied and still applies to every drug the company makes, including Sublocade, which means new competing drugs like Brixadi may have to wait until 2024 to reach the market, even though Brixadi has already been approved by the FDA and could help save thousands of lives in the meantime.

Orphan Drug No More

Despite the initial FDA ruling, addiction to opioids is not a rare disease. As many as 2.3 million people in the U.S. are addicted to prescription opioids or illicit opiates such as heroin. Indivior has already made billions of dollars from sales of Sublocade, so the company is no longer worried about recouping its initial investment.

Eager to get new addiction drugs on the market, Braeburn, the company that manufactures Brixadi, has asked the FDA to reverse its ruling on Indivior, which would void the company’s orphan drug status, so Brixadi can reach the market as soon as next year. The FDA is currently reviewing the request, but the final ruling remains to be seen.

Helping Patients Find the Right Addiction Treatment Method

So, why is it important that Brixadi reach the market as soon as possible when Sublocade has already been on the market since 2017?

Addiction to opioids is a complex issue for many patients and their care providers. There is no one-size-fits-all solution to addiction. Doctors need as many tools as possible when treating patients suffering from chronic pain and/or addiction to opioids. Some doctors may use once-a-day treatment options like methadone, while others may prescribe Vivitrol, which is injected once a month. When it comes to treating addiction and chronic pain, many doctors may prescribe a buprenorphine like Sublocade, which treats pain and addiction to opioids.

Putting another buprenorphine like Brixadi on the market would increase patient access to this potentially life-saving drug. Patients can take Brixadi once a month or once a week, so doctors have more options in terms of how often they see their patients.

There are also concerns over the price of the drug. Some insurance companies refuse to pay for Sublocade, which costs as much as $1,580 a month. Yet, a generic buprenorphine like Brixadi could cost as little as $140, lowering costs for patients and insurance companies.

Hopefully, the FDA will decide to rescind Indivior’s orphan drug status so that cheaper addiction drugs like Brixadi can go on the market. Stay tuned as the FDA continues to review this crucial request.


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