PRINCETON, N.J., Jan. 13, 2017 /PRNewswire/ -- Braeburn
Pharmaceuticals, Inc. today announced that the Centers for Medicare & Medicaid Services (CMS) has granted a Healthcare Common
Procedure Coding System (HCPCS) code, or permanent J-code, for Probuphine, the first and only six-month buprenorphine implant for
the maintenance treatment of opioid addiction. The new J-code (J0570) became effective January 1,
2017 and coincides with the activation of a new field force to drive the next phase of Probuphine adoption.
"With patients and providers urgently needing access to evidence-based treatment for opioid addiction, we are pleased that CMS
granted a J-code for Probuphine," said Behshad Sheldon, President and CEO, Braeburn
Pharmaceuticals. "We anticipate that the new code and our expanded commercial team will advance adoption of Probuphine and
broaden access for appropriate patients with opioid use disorder."
HCPCS codes are used by healthcare professionals to identify services and procedures for which they bill public or private
health insurance programs. The codes included in the HCPCS set, which is based on the American Medical Association's Current
Procedural Terminology, are maintained by CMS and universally accepted by all payers.
About Probuphine
Probuphine is the only six-month treatment for opioid dependence that delivers buprenorphine continuously using Titan
Pharmaceuticals' (NASDAQ: TTNP) ProNeura™ technology. Probuphine is placed under the skin of the upper arm during a short
outpatient office procedure and is removed in a similar manner. Probuphine is available through a closed distribution system.
Qualified healthcare providers can register for Probuphine training at www.probuphineREMS.com or by calling 1-866-397-8939. Probuphine is available in all 50 U.S. States; people
interested in finding a provider in their area can visit www.probuphinerems.com/probuphine-locator.
Probuphine Indication and Important Safety Information
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 should be used as part of a complete treatment program to include counseling and psychosocial support.
PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged
clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or
generic equivalent.
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 Braeburn Pharmaceuticals
Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering
individualized 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. 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 weekly and monthly CAM2038,
subcutaneous injection depot formulations of buprenorphine, being investigated in opioid addiction and pain, BB0417
buprenorphine/granisetron injectable for acute pain, and BB0817, six-month risperidone implant being investigated in
schizophrenia. More information on Braeburn can be found at www.braeburnpharmaceuticals.com.
Contacts:
Sherry Feldberg for Braeburn Pharmaceuticals
MSLGROUP
781-684-0770
braeburnpharma@mslgroup.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/braeburn-pharmaceuticals-probuphine-implant-receives-j-code-by-centers-for-medicare--medicaid-services-300390757.html
SOURCE Braeburn Pharmaceuticals, Inc.