Braeburn Pharmaceuticals Commends HHS Secretary Burwell for Initiative to Expand Access to Medication-Assisted Treatment for Opioid Addiction


Braeburn Pharmaceuticals, an Apple Tree Partners company, commends U.S. Department of Health and Human Services (HHS) Secretary Sylvia Burwell upon her announcement that HHS will expand access to medication-assisted treatment (MAT) as part of a multi-faceted plan to reduce opioid-related overdoses and addiction. HHS will revise federal regulations governing the prescribing of buprenorphine for the treatment of opioid use disorders to improve patient access to the medication while minimizing the risk of drug diversion and abuse.

"Today's announcement is an important step in ensuring access to high-quality medical treatment with buprenorphine for all patients with opioid dependence," said Behshad Sheldon, President and CEO of Braeburn. "Braeburn supports raising the patient limit in a responsible manner that balances increased access with high-quality treatment following best practices to minimize diversion and abuse."

Buprenorphine is unique among the medications approved by the Food and Drug Administration (FDA) for the treatment of opioid dependence because it reduces withdrawal symptoms and cravings—without interfering with a person's natural ability to experience emotion—and may be prescribed in an office-based setting. Under the Drug Addiction Treatment Act of 2000 (DATA 2000), physicians in office-based settings may treat only 30 patients with buprenorphine at any one time during the first year they are authorized to prescribe buprenorphine and a maximum of 100 patients thereafter.

The buprenorphine patient limit was intended to prevent diversion and abuse of the medication. At the time the current limits were established, the U.S. had not yet experienced epidemic levels of opioid abuse and the corresponding high demand for addiction treatment provided by well-qualified practitioners. Now, as 2.5 million Americans need treatment for opioid use disorder and only 1 million receive it, the buprenorphine patient limit excessively restricts the appropriate practice of addiction medicine while inadequately deterring improper prescribing.

DATA 2000 prevents highly qualified physicians and advanced practitioners (who are not eligible to prescribe buprenorphine under DATA 2000) who follow best practices from providing more than 100 patients treatment with buprenorphine. At the same time, DATA 2000 does not do enough to help ensure that physicians permitted to treat buprenorphine in office-based settings do so in accordance with well-established best practices in addiction medicine. While buprenorphine has repeatedly been shown to be effective in treating opioid addiction, it is most effective when provided as part of a comprehensive treatment program that includes behavioral therapy and ongoing monitoring for adherence to the treatment plan.

"We applaud the Secretary's commitment to adjusting the buprenorphine patient limit in a way that advances evidence-based practices," Sheldon stated. "Exempting patients treated with implants and injectables from the patient limit would be one way to incentivize the development of innovative, long-acting technologies to expand access while ensuring patient compliance and minimizing the risk of diversion and abuse. We encourage HHS to consider this option as it revises the regulations."

About Braeburn Pharmaceuticals

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a late-stage specialty pharmaceutical company focused on novel, long-acting implantable and injectable therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Long-acting therapeutic treatment options can be essential to improving patient outcomes and facilitating recovery in these conditions, which are often complicated by stigma and present significant public health challenges. Braeburn's investigational product pipeline includes: Probuphine®, a six-month buprenorphine implant for treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine for treatment of opioid addiction and pain; a risperidone six-month implant for treatment of schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. For more information on Braeburn,