Loopholes May Lead FDA to Block New Buprenorphine Alternatives

By Bryan Le 05/28/19

Despite an ongoing epidemic, alternatives to Sublocade are not allowed to enter the market.

Businesspeople discussing FDA loopholes
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Thanks to so-called “orphan drug” legal loopholes, Sublocade might be the only buprenorphine product on the market until 2024.

For any medical issue, patients have to try different avenues of treatment to find the most effective one. This need for alternatives is especially important for finding treatments for opioid addiction considering the crisis is taking around 130 lives in the U.S. each day.

“It's important to have multiple different treatment options for different patients, different circumstances,” says Carolyn Bogdon, a South Carolina-based family nurse practitioner.

Several methods for opioid addiction treatment exist. For example, there is the daily dosing of methadone or the once-monthly Vivitrol injection. Another alternative is buprenorphine, an opiate that blocks the same receptors that opioid painkillers would without providing the high. It can be taken as a film or tablet once or twice a day.

One buprenorphine product, called Sublocade, only needs to be taken once a month. Currently, there aren’t any comparable alternatives, but that’s not for lack of competition. A company called Braeburn has produced at least one long-lasting buprenorphine alternative, called Brixadi, but it just can’t be sold right now.

“It's ready for market now,” said Mike Derkacz, CEO of Braeburn. “We are deemed safe and effective by FDA, but we are unable to make the product available to patients during this crisis.”

When Sublocade was released in 2017, it enjoyed three years of exclusivity as part of the standard allowance for any new drug. However, Sublocade seems to be in line to get seven years of exclusivity as the FDA may consider it an orphan drug.

Typically, an orphan drug is defined by the FDA as a medication that treats ailments that affect less than 200,000 people a year. Technically speaking, the opioid crisis does not qualify, with 2.3 million people addicted and 47,000 who died in 2017 alone.

The decision to consider Sublocade an orphan drug is made even more perplexing to Derkacz by the fact that the Trump administration declared the opioid crisis a national emergency.

“There have been studies that show a reduction in mortality by 40% with buprenorphine,” claimed Derkacz. “That keeps people alive. That gives people a chance to get back to their lives and recover fully.”

Drugs like Sublocade and Brixadi are especially useful for people who can’t or don’t want to take daily doses of methadone.

“It provides a little bit more anonymity for patients that don't want to disclose that they have an opiate use disorder,” said Michelle Lofwall, a Kentucky-based psychiatrist.

“Some patients have felt stigmatized when going to the pharmacy, like they don't feel like they're necessarily treated all that well once they show their prescription.”

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Bryan Le grew up in the 90's, so the Internet is practically his third parent. This combined with a love for journalism led him to The Fix. When he isn't fulfilling his duties as Editorial Coordinator, he's obsessing over fancy keyboards he can't justify buying. Find Bryan on LinkedIn or Twitter