Seventeen Days After Receiving FDA Approval, Braeburn Pharma Announces First Patients Have Received Probuphine (Buprenorphine) Implant
PRINCETON, N.J., June 20, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals announces that 10 patients have already been treated with the Probuphine (buprenorphine) Implant, making them the first people in the United States to receive this new medication that was recently approved by the Food and Drug Administration (FDA) on May 26, 2016.
Dr. Steven Chavoustie, of the Segal Institute for Clinical Research in Miami, Florida; Dr. Mike Frost, medical director, Eagleville Hospital in Conshohocken, Pennsylvania; Dr. Marc Maskowitz, Paincare Medical Practice in Sacramento, California and Dr. Matthew Torrington, Los Angeles, California were the first doctors to implant Probuphine since approval.
To date, more than 1,100 healthcare providers in 44 states have been certified to provide this new medication to patients. More than 5,000 healthcare providers have requested additional information on Probuphine training and will have the opportunity to participate in one of 252 training sessions in 55 U.S. cities this summer, bringing the total number of certified physicians to more than 2,000 by the end of July and a total of more than 4,000 healthcare providers by the end of 2016.
"The Braeburn team is relentlessly focused on healthcare provider implant training and insurance reimbursement in order to ensure swift access to Probuphine for patients," said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. "We hope the Probuphine Healthcare Provider Locator on ProbuphineREMS.com will make it simpler for patients to find treating physicians in their area."
"The large number of qualified healthcare providers signing up for the Probuphine trainings is proof that the medical community sees the potential this new option may offer their patients," said Dr. Chavoustie who collaborated with the FDA to finalize the training program on the procedures. "Prior to attending the training sessions, many of the participating healthcare providers surveyed their patients currently stable on low to moderate doses of oral buprenorphine and found that they share the same excitement that Probuphine is now available."
Insurers have also expressed strong interest in discussing how they would provide coverage for Probuphine. Several BCBS plans as well as United Healthcare were among those that approved reimbursement for the first patients implanted.
Qualified healthcare providers that are interested in attending a certification course in their area can register at www.probuphineREMS.com or by calling 1-866-397-8939. Patients can locate certified healthcare providers in their area that have been certified to implant patients by using the physician locator at www.probuphineREMS.com.
About Probuphine
PROBUPHINE is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet or generic equivalent). PROBUPHINE be used as part of a complete treatment program to include counseling and psychosocial support.
Probuphine is the only six-month treatment for opioid dependence that delivers buprenorphine continuously using Titan Pharmaceuticals' ProNeura technology. Probuphine is not distributed by pharmacies; qualified healthcare providers can register for Probuphine training at www.probuphineREMS.com or by calling 1-866-397-8939. Patients can locate certified healthcare providers at www.probuphineREMS.com by using the physician locator.
Probuphine is significantly lower cost than a six month-course of other long-acting medications for opioid addiction.
WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL
Risk Associated with Insertion and Removal
Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion.
Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions.
Please see additional Important Safety Information in the Package Insert that can be found at probuphine.com or by following this link http://probuphinerems.com/wp-content/uploads/2016/02/final-approved-pi.pdf.
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. Before FDA approval of Probuphine, buprenorphine was only available in oral form which must be taken daily.
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 neurological and psychiatric disorders, which are often complicated by stigma and present significant public health challenges. Probuphine, Braeburn's long-acting buprenorphine implant, was approved by the FDA in May 2016. 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. Braeburn's pipeline products are at various stages of clinical development and include 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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