In Midst Of Opioid Crisis, FDA May Block New Addiction Drug From Market

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More than 130 people in the U.S. die of an opioid overdose every day. One of the most effective ways to save lives is to get those struggling with addiction treated with medication to stop their cravings. But a loophole in federal law might block at least one new opioid-addiction drug from coming to market for years.

Many patients have to try several medications before finding one that works for them and that they can stick with.

"It's important to have multiple different treatment options for different patients, different circumstances," says Carolyn Bogdon, a family nurse practitioner who oversees outpatient medication-assisted treatment programs at the Medical University of South Carolina in Charleston, S.C.

Some use methadone, which they get every day. Others use Vivitrol, which can be injected once a month. And many use buprenorphine, which comes in tablets and a dissolvable film that people take once or twice a day. Buprenorphine is an opiate, but it blocks the cravings associated with addiction without giving people the same high.

A handful of patients at the university's clinics have moved to a form of buprenorphine called Sublocade that's injected just once a month.

And if the company that makes Sublocade gets its way, the drug will be the only long-acting buprenorphine on the market for five more years.

FDA and 'orphan drugs'

That's because a quirk in federal law may prevent a competing drug called Brixadi from going on sale until 2024. "It's ready for market now," says Mike Derkacz, CEO of Braeburn, which makes Brixadi. "We are deemed safe and effective by FDA, but we are unable to make the product available to patients during this crisis."

Sublocade was approved for sale in 2017 and, like any new drug, was granted three years of exclusive access to U.S. markets. That time is up next year. But in December, the Food and Drug Administration told Braeburn it might have to wait four more years because Sublocade was designated an "orphan drug," which gives it seven years of exclusive access.

Sublocade, which is made by Indivior, isn't an orphan drug in the traditional sense. Normally, these are medications that treat illnesses affecting fewer than 200,000 people a year.

Opioid addiction is not a rare disease.

In 2017, according to the National Institute on Drug Abuse, about 2.3 million people in the U.S. were addicted to prescription opioids or illicit opiates such as heroin, and 47,000 people died of an overdose.

The Trump administration declared opioid addiction a public health emergency that same year — just a month before Sublocade hit the market — and made helping people get medication-assisted treatment a priority.

That's why the makers of Brixadi were shocked when the FDA gave their product only tentative approval in December. Derkacz says it doesn't make sense, in the middle of what many call an epidemic, to treat buprenorphine drugs as if they treat a rare disease.

"There have been studies that show a reduction in mortality by 40% with buprenorphine," Braeburn's CEO says. "That keeps people alive. That gives people a chance to get back to their lives and recover fully."

A back-door approach

So why is Sublocade considered an orphan drug? Like many things related to prescription drugs, the reasons are wonky and sort of irrational.

Indivior created its first buprenorphine-based drug, called Subutex, in the 1990s. At the time, treating addiction with other drugs wasn't mainstream. There were methadone clinics in some U.S. cities, but they were heavily regulated by law.

The company asked the FDA to give it orphan drug status — but instead of saying there weren't many potential patients, Indivior said it had little hope of earning back its investment in Subutex and needed extra time with no competition. Few drugs have ever received orphan status this way. But at the time, it made sense to the FDA.

The orphan designation was granted, and Subutex hit the market in 2002.

Since then, Indivior has made billions in revenue from sales of the drug and its successors, Suboxone and Sublocade, partly because the orphan designation is automatically attached to every new formulation of buprenorphine the company makes.

Indivior's executives declined to be interviewed for this story. But in response to written questions, the company says, "Indivior stands by FDA's decision, which was supported by both the law and the facts at that time."

Derkacz says Braeburn has asked the Food and Drug Administration to revoke Sublocade's orphan status. And an FDA spokeswoman says the agency is actively considering that request.

The right drug 'can save their life'

Long-acting, injectable treatments for addiction have some advantages over tablets and dissolvable films. Patients don't have to remember to take medication each day, and they can avoid the drugstore.

"It provides a little bit more anonymity for patients that don't want to disclose that they have an opiate use disorder," says Michelle Lofwall, a psychiatrist and medical director at two University of Kentucky clinics that treat patients struggling with opioid addiction.

"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," she says.

Lofwall participated in Brixadi's clinical trial, so she's one of the few health care providers who has used both medications. She says they're slightly different and that she'd like to have the choice to offer her patients.

"From a public health perspective, and just as a provider physician trying to treat patients, they need to have all the options," Lofwall says. Being on the right drug "literally can save their life."

"As a clinician, it's always important for me to have more tools," Andrea Barthwell, an addiction treatment specialist, wrote in public comments on Braeburn's FDA petition. "Moreover, there are gaps in care from the current buprenorphine treatment options that Brixadi may fill."

Brixadi can be used weekly as well as monthly, allowing doctors to see their patients more frequently and monitor them more closely at the start of treatment, according to several comments.

Another issue is cost.

Sublocade costs about $1,580 per month, according to marketing materials from Indivior, and some insurance companies won't pay for it. "In Kentucky," Lofwall says, "we haven't been able to get it for patients who are on several different Medicaid managed-care programs."

By contrast, a generic version of the buprenorphine film costs about $140 a month, according to the website GoodRX.com.

Daniel Smith, who leads the medication-assisted treatment program at Mary's Center in Washington, D.C., says he doesn't know any doctors who use Sublocade now.

"Long-acting buprenorphine is definitely advantageous over short-acting for many reasons, but cost and availability have been the challenge," he says.

But if a competitor drug came on the market, Smith says the price of Sublocade might fall, and he might then be willing to prescribe it to his patients.