PRINCETON, N.J., Oct. 22, 2015 /PRNewswire/ -- Braeburn Pharmaceuticals commends President Barack Obama for highlighting the importance of removing barriers to medication-assisted treatment (MAT) for people with opioid addiction. The president announced a series of initiatives among the public and private sectors and at all levels of government to address the opioid abuse epidemic. The president’s engagement amplifies the recent announcement by Department of Health and Human Services (HHS) Secretary Sylvia Burwell that HHS will revise federal regulations to expand access to MAT.
President Obama’s announcement focused on nationwide efforts to generate greater public awareness, educate opioid prescribers, and improve access to MAT for opioid use disorders. The Obama Administration has expanded insurance coverage of treatment for substance use disorders under the Affordable Care Act and has committed to improving access to FDA-approved medications containing buprenorphine for the treatment of opioid use disorders.
“President Obama’s personal engagement is critical to raising awareness of the fact that opioid addiction is a problem for all of us and requires action from both the private and public sectors,” said Behshad Sheldon, President and CEO of Braeburn.
The Obama Administration has supported public-private cooperation to improve care for people with opioid use disorders since the president’s first year in office. In 2009, the National Institute on Drug Abuse (NIDA) provided a research grant to expedite the development of Probuphine®, an investigational, long-acting, implantable formulation of buprenorphine under development by Braeburn with Titan Pharmaceuticals, Inc. The Probuphine implant is intended to provide a consistent level of the medication for six months following a single treatment.
In addition to HHS and NIDA, the Food and Drug Administration (FDA) is also actively implementing the President’s plan to reduce opioid abuse and addiction, including issuance of guidance on abuse-deterrent formulations of opioids. FDA has provided Braeburn with guidance on the design of clinical trials of Probuphine and granted priority review for the Probuphine New Drug Application. FDA has designated February 27, 2016 as the target date for Agency action.
“Our vision is for patients to have safe and effective long-acting, pill-free options that deliver precision medicine in neuroscience. This means ensuring that patients get the right dose for an optimal duration. Probuphine is our foundational product, and we are dedicated to continuing research, development, and education in collaboration with both public and private partners active in treatment of opioid addiction and pain,” Sheldon said.
Currently available buprenorphine medications for opioid addiction are oral forms that require daily self-administration by patients. These traditional formulations are highly susceptible to risks of diversion, misuse, abuse, and accidental exposure given that patients must take responsibility for their post-dispensing storage, proper use, and disposal.
If approved by FDA, Probuphine and other long-acting implants and injectables for addiction, pain, and other conditions could help reduce the problems that President Obama, Secretary Burwell, NIDA, FDA, and other stakeholders nationwide are working to address.
About Probuphine®
Probuphine is an investigational subdermal implant designed to deliver buprenorphine around the clock for six months following a single treatment and to promote patient compliance and retention. Buprenorphine, which is the active ingredient in multiple FDA-approved drug products for the treatment of opioid dependence, is currently available in tablet and film formulations that require self-administration by patients on a daily basis.
Probuphine was developed using ProNeura, Titan Pharmaceuticals’ continuous drug delivery system that consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting construct is a solid matrix that is placed subdermally, normally in the upper arm, in an outpatient office procedure, and removed in a similar manner at the end of the treatment period.
The efficacy and safety of Probuphine has previously been studied in several clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow-on study of 287 patients (published in the journal Addiction).
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. In September 2015 the Food and Drug Administration (FDA) accepted for review Braeburn’s New Drug Application for its lead candidate, Probuphine, a six-month buprenorphine implant for treatment of opioid addiction. The Agency set February 27, 2016 as the target date for action.
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 consists of long-acting therapies for serious neurological and psychiatric disorders, including addiction, pain, and schizophrenia. Candidates include: 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. More information on Braeburn, an Apple Tree Partners company, can be found at www.braeburnpharmaceuticals.com.
CONTACT:
Jim Weinrebe
MSLGROUP
781-684-0770
braeburnpharma@mslgroup.com
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SOURCE Braeburn Pharmaceuticals
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