PRINCETON, N.J. and SAN FRANCISCO, April 25, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals announced the presentation of health outcomes data based on the results from the Phase 3 clinical trial of Probuphine, a six month subdermal buprenorphine implant, for clinically stable adults with opioid use disorder. The data was presented Friday at the annual meeting of the Academy of Managed Care Pharmacy (AMCP). The AMCP is a national professional association of pharmacists, health care practitioners and others who develop and provide clinical, educational and business management services on behalf of more than 200 million Americans covered by a managed pharmacy benefit.
"The objective of this analysis was to examine the societal impact of Probuphine when compared to sublingual buprenorphine in clinically stable adults," said Mike Frost, M.D., medical director, Eagleville Hospital. "The potential effects of the buprenorphine implant versus sublingual buprenorphine were modeled with clinical trial data and inputs drawn from the literature using a 5-state Markov model. The modeled results included a 24% reduction in drug-related deaths and an 80% reduction in rehabilitation services utilization. It also predicted a 98% reduction in accidental pediatric exposure to sublingual buprenorphine."
"The benefits seen through this model demonstrate the impact of sustained abstinence during treatment," said Walter Ling, professor of psychiatry and director of Integrated Substance Abuse Programs (ISAP), David Geffen School of Medicine, UCLA. "An implantable formulation of buprenorphine could present physicians, patients and society with a new option that mitigates some risks associated with sublingual formulations. Patients may have decreased preoccupation with their ritual of taking medication daily, giving them freedom to focus on other parts of their recovery."
"As the opioid epidemic continues to grow, patients and physicians are in desperate need for more treatment options like Probuphine," said Behshad Sheldon, president and CEO, Braeburn Pharmaceuticals. "We will continue to study the potential benefits of Probuphine because we understand the value that additional data like this offers in determining how to best treat patients with this chronic brain disease."
About Opioid Use Disorder and Buprenorphine
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. In the U.S., 2.5 million people struggle with opioid addiction and, according to the Centers for Disease Control, 78 people die each day from the disease. There is a growing body of evidence that opioid addiction is not a choice or a moral failing, but the result of genetic predisposition combined with environmental factors. Nonetheless, individuals struggling with this disease continue to be stigmatized. Research has also shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid addiction cannot sustain recovery without long-term outpatient medical treatment.
Buprenorphine is a partial opioid agonist, which may help individuals to stop opioid use without experiencing withdrawal symptoms. Buprenorphine is currently only available in oral form and must be taken daily.
About Probuphine
Probuphine is currently undergoing final review by the U.S. Food and Drug Administration (FDA) following a 12 to 5 vote in January by the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) in favor of approving Probuphine. If approved, Probuphine would be the first long-acting, subdermal buprenorphine implant for the maintenance treatment of opioid addiction. The implant was developed using Titan Pharmaceuticals' proprietary platform technology, ProNeura™, a non-biodegradable drug delivery implant designed to provide continuous, long-term steady state levels of medication in the blood. It is administered in a subdermal insertion procedure in a physician's office and removed similarly at the end of the treatment period.
For more information about Probuphine, please visit www.braeburnpharmaceuticals.com.
About Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience. 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 implantable and injectable therapies for serious neurological and psychiatric disorders, including opioid addiction, pain, and schizophrenia. Candidates include: Probuphine®, a six-month buprenorphine implant under review at the FDA for the treatment of opioid addiction; CAM2038, weekly and monthly subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain; a risperidone six-month implant being investigated in schizophrenia; and a novel molecule, ATI-9242, for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.
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