SAN JUAN, Puerto Rico, Aug. 2, 2016 /PRNewswire-HISPANIC PR WIRE/ — Braeburn Pharmaceuticals announces that healthcare provider training and certification for Probuphine will take place on August 5, 6 and 7 in San Juan. 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 San Juan 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. In Puerto Rico, it is estimated that approximately 70,000 people are addicts, and that $3 million per day is spent on illicit drugs. 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 San Juan 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 San Juan on August 5, 6 and 7 on best practices for insertion and removal of Probuphine, the only treatment for opioid dependence that delivers medicine for up to six months. To date, 2,342 physicians from all 50 states and Puerto Rico have been certified to provide Probuphine 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 San Juan are part of a series of 262 that Braeburn is conducting across 55 cities this summer.
Probuphine is the only FDA approved long-acting buprenorphine treatment for opioid dependence. Probuphine delivers buprenorphine continuously for six months using Titan Pharmaceuticals’ (NASDAQ: TTNP) ProNeura™ technology. Probuphine is placed under the skin of the upper arm during an outpatient office procedure and is removed in a similar manner.
For More Information on Probuphine
Probuphine is now available in all 50 U.S. States. Patients interested in Probuphine should visit the Probuphine Healthcare Provider Locator to find a trained and certified provider near them: www.probuphinerems.com/probuphine-locator.
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.
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 pharmaceutical company focused on long-acting therapeutic treatment options that are 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. Braeburn’s commercial product, Probuphine® (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, is being investigated for treatment of schizophrenia. More information on Braeburn, can be found at www.braeburnpharmaceuticals.com.
Sherry Feldberg or Rachel Gross
Coltrin & Associates, Inc.