Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade

Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade

Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine OUD Treatment Will Enter the Market until Late 2024

Plymouth Meeting, Pa. — April 9, 2019 — Braeburn Inc. has filed a Citizen Petition (CP) with the Food and Drug Administration (FDA) calling on FDA to protect the integrity and intent of the Orphan Drug Act by revoking the orphan drug designation (ODD) for Sublocade (buprenorphine extended-release) injection for the treatment of  opioid use disorder (OUD). The CP also calls on FDA to refuse to grant a seven-year orphan drug exclusivity period (ODE) to Sublocade, which would likely prevent approval of any other OUD buprenorphine product until the end of 2024.

ODD and ODE are intended to treat rare conditions with small, underserved patient populations, not conditions such as OUD which affect more than 2,000,000 Americans. Typically, incentives like orphan exclusivity are only available for conditions that affect less than 200,000 Americans. In very rare circumstances – of which there have been three instances in the 35 years since the introduction of the Orphan Drug Act – ODD can be awarded if there are more than 200,000 Americans affected but there is “no reasonable expectation” of recovering development and marketing costs. This approach was utilized nearly 25 years ago in 1994 to grant ODD to a different buprenorphine drug for OUD (Subutex (buprenorphine sublingual tablets)). FDA has now “grandfathered” the Subutex ODD to Sublocade – without revisiting the 1994 data or considering Sublocade’s current eligibility as an “orphan drug” – simply because the developer of Subutex and Sublocade is the same.

The CP also explains that information and assumptions submitted to FDA in 1994 were flawed. Extraordinary changes occurred in the OUD market before Subutex’s approval in 2002, mainly via the enactment of the Drug Addiction Treatment Act in 2000 (DATA 2000) following successful lobbying efforts by Subutex’s developer. The passage of DATA 2000 substantially changed the way OUD is treated, resulting in an enormous expansion of the use of Subutex (and Suboxone (buprenorphine and naloxone sublingual tablets)). These changes enabled Subutex to generate hundreds of millions of dollars of sales and, together with Suboxone, was successfully leveraged into an “OUD buprenorphine franchise” that has generated more than $10 billion in net sales over nearly two decades. For these reasons, Subutex was not ever a bona fide orphan drug and ODD should have been revoked at or before Subutex’s approval in 2002.

In addition, Sublocade itself is expected to reach peak sales of more than $1 billion per year by treating an OUD population that is at least 10 times higher than the orphan threshold. Given these considerations and the exponential growth of the opioid crisis, Sublocade is not a bona fide orphan drug and should not be permitted to rely on a prior ODD decision made nearly 25 years ago.

“At a time of national emergency, FDA should follow through on its commitment to expand access to new addiction treatments. It is universally accepted that OUD patients need more treatment alternatives and more access, and we are especially concerned that if FDA were to grant orphan drug exclusivity to Sublocade, no other buprenorphine products for OUD will come to market until the end of 2024. Such an outcome would clearly contradict FDA’s goals of expediting approval of buprenorphine products as set out in recently issued FDA Guidance,” said Mike Derkacz, President and CEO of Braeburn.

“FDA has the legal authority, but more importantly a clear obligation to its public health mission, to revoke the orphan drug designation. With millions impacted by the opioid crisis, OUD is clearly not an orphan disease and Sublocade is not a bona fide orphan drug,” Derkacz added.

Revoking ODD for Sublocade is necessary to prevent inappropriate and abusive “evergreening” tactics that virtually eliminate new buprenorphine treatments from entering the market.

A link to the CP can be found here.

District Court Filing in the District of Columbia

In December 2018, FDA found Braeburn’s new drug, BRIXADI™ (buprenorphine) extended-release injection, safe and effective following the completion of seven clinical studies. BRIXADI was granted Tentative Approval by FDA but is not eligible for full approval until November 30, 2020, due to FDA awarding a three-year “clinical exclusivity” period to Sublocade (which is separate to, and independent of, the ODE referenced in the CP). Braeburn intends to file court proceedings today seeking to overturn FDA’s three-year clinical exclusivity decision and grant immediate approval of BRIXADI.

About BRIXADI (buprenorphine) Extended Release Injection for SC Use (CIII)

BRIXADI is an extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe OUD. BRIXADI is tentatively approved by FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI will be administered only by healthcare providers (HCPs) in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.

About Braeburn

Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. Our mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, HCPs, payers and society. For more information about Braeburn, please visit

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