Opioid Addiction: FDA May Keep New Medication Off Market Over Legal Quirk : Shots - Health News A quirk in the law gives an older opioid addiction treatment "orphan drug" status — and a period of exclusive market access. That may prevent some new therapies from reaching patients for years.

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

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In the U.S., more than 130 people die every day from an opioid overdose. One effective way to save lives is get people who are addicted to opioids treatment with medication that can stop their cravings. But a loophole in federal law may keep at least one of those new drugs from coming to the market for five years, as NPR's Alison Kodjak reports.

ALISON KODJAK, BYLINE: When it comes to treating opioid addiction, Carolyn Bogdon wants choices.

CAROLYN BOGDON: It's important to have multiple different treatment options for different patients, different circumstances.

KODJAK: Bogdon is a nurse practitioner and director of the medication-assisted treatment program at the Medical University of South Carolina in Charleston.

BOGDON: Some of the medications, you have to go to a clinic and receive it every day. Some of it you can get a prescription for. Some of it's injectable, and it lasts for 30 days, you know. So, again, it really, I think, depends on the patient, their circumstances, where they are in life.

KODJAK: That once-a-month injection she mentioned is a medication called Sublocade. It contains a widely used ingredient called buprenorphine, which has been available as a dissolvable tablet or film for many years. It's an opiate itself, but it blocks the cravings associated with addiction without giving people the same high. Bogdon says a handful of her clinic's patients are using it, and she's glad to have it as an option.

But if Indivior, the company that makes a Sublocade, gets its way, it will be the only long-acting buprenorphine on the market for another five years. That's because a quirk in federal law may block a competing drug called Brixadi from going on sale until 2024.

MIKE DERKACZ: We are deemed safe and effective by FDA. But we are unable to make the product available to patients during this crisis.

KODJAK: That's Mike Derkacz, CEO of Braeburn, which makes Brixadi. The drug normally would be able to go on sale next year when Sublocade's three years of exclusive market access expire. But Braeburn may have to wait four additional years because the FDA has designated Sublocade an orphan drug, which gives it seven years of exclusive access to the U.S. market. That's because orphan drugs, in theory at least, treat rare diseases, but opioid addiction isn't rare. It affects more than 2 1/2 million people in the U.S. alone.

DERKACZ: In a crisis that we face right now, we need products that work in the market and available to these patients.

KODJAK: So why is Sublocade considered an orphan drug? Like many things related to prescription drugs, the reasons are wonky and sort of irrational. Indivior, the company that makes Sublocade, first asked the FDA for approval for a buprenorphine drug called Subutex in 1993. At that time, treating addiction with other drugs was rare. There were methadone clinics in some cities, but they were heavily regulated. And Indivior used a backdoor to get its orphan status. Rather than saying there weren't many potential patients, the company said it had little hope of earning back its investment in Subutex. Very few drugs have ever received orphan designation this way, but the FDA granted it in this case.

Since Subutex went on sale, the company has made billions in revenue on it and its successors because the laws have changed and the orphan designation automatically attached to every new version of buprenorphine that Indivior makes, including Sublocade. Indivior's executive declined to be interviewed for this story. But in response to written questions, the company says the FDA's orphan designation was supported by the law and the facts at the time.

MICHELLE LOFWALL: Opiate use disorder is not a rare condition. So on that part of it, it doesn't ring true to me.

KODJAK: That's Michelle Lofwall, a psychiatrist and medical director at two University of Kentucky clinics that treat patients struggling with opioid addiction. She says medications that can last a week or a month are a real advantage to many patients who struggle to take their medicine on a rigid daily schedule.

LOFWALL: The person just needs to get a monthly injection. And they will have the active medication that helps prevent overdose death and decreases craving and prevents onset of withdrawal.

KODJAK: 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 she'd like to have the choice to offer her patients. Plus, she says, competition may cut the price. Right now, Sublocade costs about $1,500 a month. The tablets and film cost just a fraction of that. So Lofwall says some insurance companies won't pay for the more expensive injection.

LOFWALL: This can really save lives. And so the fact that we have, you know, potentially two new depot products, that's really exciting. And so, you know, hopefully we can get them both available.

KODJAK: Derkacz of Braeburn says his company has asked the FDA to revoke Sublocade's orphan designation. And an FDA spokeswoman says the agency is actively considering that request. Alison Kodjak, NPR News.

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