Braeburn Pharmaceuticals Announces Commercialization Plans for Probuphine® (buprenorphine) Implant, Six-Month Treatment for Opioid Dependence

PRINCETON, N.J., May 31, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals announces plans to make Probuphine available to healthcare providers and patients in June, immediately following Food and Drug Administration (FDA) approval 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. 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.

"Now that the FDA has approved Probuphine, Braeburn's top priorities are to train and certify healthcare providers to make Probuphine available to patients across the country and to establish insurance coverage as quickly as possible," said President and CEO Behshad Sheldon, Braeburn Pharmaceuticals. "Braeburn is confident in Probuphine's value and is exploring reimbursement approaches with insurers including value-based programs. A payment assistance program will also be put in place to ensure access to Probuphine for patients."

Braeburn has received requests for information on Probuphine training from more than 5,000 healthcare providers, and several insurers have expressed interest in discussing the addition of Probuphine to their formularies. To ensure swift access to Probuphine, Braeburn is conducting 262 Probuphine training sessions across 55 cities over the next six weeks. The architect of the training program, Dr. Steven Chavoustie, gynecologist at the Segal Institute for Clinical Research, Miami, and Braeburn Pharmaceuticals collaborated with the FDA to finalize the training program on the procedures.

"We began training this past weekend, including a session on Memorial Day," said Dr. Chavoustie. "The first 121 healthcare providers are now certified to provide treatment with Probuphine. We look forward to the safe and effective use of this new alternative in battling the devastating disease of opioid addiction."

Braeburn will continue to hold training sessions frequently throughout the year and expects to train at least 2,000 healthcare providers over the next six weeks and will have the capacity to train more than 4,000 healthcare providers by the end of 2016. Qualified healthcare providers can register for Probuphine training here or by calling 1-866-397-8939. A Probuphine healthcare provider locator is available at www.probuphineREMS.com.

Probuphine will be priced at $4,950 for a six-month course of treatment which is significantly lower than a six month-course of other long-acting medications for opioid dependence. A specialty distributor will send Probuphine directly to trained and certified providers.

Probuphine is the only treatment for opioid dependence that delivers buprenorphine continuously for six months. Based on preliminary pharmacoeconomic modeling data that was presented at two recent academic conferences, Academy of Managed Care Pharmacy (AMCP) and Council of State and Territorial Epidemiologists (CSTE), Probuphine patients were predicted to have a 45% lower chance of relapse, an 80% lower chance of going to rehab and a 98% lower chance of pediatric exposure s vs. patients taking oral buprenorphine.

As part of the value-based reimbursement programs that Braeburn is discussing with insurers, Braeburn is prepared to provide a rebate if the overall cost of care for a group of patients taking Probuphine exceeds the cost of treatment for the same patients in a prior six month period, or a comparable group of patients taking other forms of buprenorphine (or other available opioid addiction medication) for a six month period.

About Probuphine

Probuphine is the only six-month treatment for opioid dependence and was developed using ProNeura™, Titan Pharmaceuticals' (NASDAQ: TTNP) 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.

INDICATION STATEMENT

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.

CONTRAINDICATIONS

• Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).

WARNINGS AND PRECAUTIONS

• Serious Complications from Insertion and Removal: 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. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program, prior to performing insertions or prescribing PROBUPHINE implants.
• Addiction, Abuse and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
• Respiratory and CNS Depression: Significant respiratory depression and death have occurred in association with buprenorphine particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other CNS depressants (including alcohol). Consider dose reduction of CNS depressants when used concomitantly.
• Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.
• Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
• Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children.
• Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.
• Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment.
• Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE.
• Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect.
• Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea, upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation, and vomiting.

Please read the full prescribing information, including boxed warning and Medication Guide, which you can access at https://braeburnpharmaceuticals.com/wp-content/uploads/2016/05/Probuphine-Full-Prescribing-Information.pdf.

To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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 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.

Media Contacts:
Sherry Feldberg or Rachel Gross
781-684-0770
[email protected]

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