LOUISVILLE, Ky., June 9, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals announces that healthcare provider training and certification for Probuphine will take place on June 10, 11 and 12 in Louisville. Approved by the Food and Drug Administration (FDA) on May 26, 2016, Probuphine is the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day.
Healthcare providers in the Louisville area can register for Probuphine training here or by calling 1-866-397-8939.
Opioid use disorder is a chronic brain disease and one of the fastest growing public health epidemics in America. Last year in Kentucky, 1,007 people died from an opioid overdose. Research has shown that opioid use disorder is best treated with a combination of medication and psychosocial support. The majority of individuals with opioid use disorder cannot sustain recovery without long-term outpatient medical treatment.
"Braeburn is committed to making Probuphine available to patients in the Louisville area and across the country as soon as possible, which is why we're conducting training sessions so quickly after receiving FDA approval for Probuphine," said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. "We look forward to educating qualified healthcare providers in Louisville on June 10, 11 and 12 on best practices for insertion and removal of Probuphine, the only treatment for opioid dependence that delivers medicine for up to six months. In the first two weekends, we certified 500 healthcare providers to provide the treatment to their patients."
Probuphine will not be distributed by pharmacies; patients can only receive the treatment from certified healthcare providers who have been specially trained to insert the implants just under the skin of the inside of the upper arm through an in-office procedure.
This weekend's training sessions for Probuphine in Louisville are part of a series of 262 that Braeburn is conducting across 55 cities this summer. Braeburn has received requests for information on Probuphine training from more than 5,000 healthcare providers and expects to train at least 2,000 healthcare providers by the end of July 2016 and more than 4,000 healthcare providers by the end of 2016.
Probuphine is the only six-month treatment for opioid dependence and 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. Probuphine implants are 26 millimeters long and 2.5 millimeters in diameter, or about the size of a matchstick. Each implant contains the equivalent of 80 mg of buprenorphine and is placed under the skin in the inner side of the upper arm.
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.
Sherry Feldberg or Rachel Gross
Coltrin & Associates, Inc.
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SOURCE Braeburn Pharmaceuticals