Probuphine® (buprenorphine) Implant Phase 3 Data Presented at CPDD Annual Scientific Meeting

PRINCETON, N.J. and PALM SPRINGS, Calif., June 16, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals presented data yesterday from the poster of the Phase 3 study of Probuphine, a six-month subdermal buprenorphine implant for the long-term maintenance treatment of opioid dependence, at the 78^th Annual Scientific Meeting of The College on Problems of Drug Dependence (CPDD). The U.S. Food and Drug Administration (FDA) approved Probuphine on May 26, 2016.

The study demonstrates that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to Probuphine and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine.  

Primary efficacy analysis originally presented showed that 96.4 percent of participants in the Probuphine group had at least four months without evidence of drug use versus 87.6 percent in the sublingual buprenorphine group, demonstrating superiority of Probuphine with a p value of 0.034. 

Additional sensitivity analyses were conducted to support the robustness of the primary analysis, including the following that were presented at CPDD:

• Statistically significant difference between Probuphine and sublingual buprenorphine in the proportion of subjects for all 6 months without evidence of illicit opioid use (85.7% versus 71.9%, p=0.03). Imputation of all missing values as positive for illicit opioids also demonstrated significant difference (80.5% versus 67.4%, p=0.05).
• A more conservative approach, including the use of supplemental sublingual buprenorphine as non-responders as well as imputing all missing values as positive for illicit opioid use, illustrated similar results for Probuphine and sublingual buprenorphine (63.2% versus 53.9%, p=0.21).

"Non-adherence to medication approved to treat opioid dependence is a leading cause of relapse," said Frank J. Vocci, Ph.D., president and senior research scientist, Friends Research Institute. "The study results show that more participants in the implant group sustained at least four months of abstinence from opioids than participants in the sublingual buprenorphine group. Implanted just under the skin, Probuphine encourages treatment adherence and adds a new treatment for doctors to utilize to address the opioid dependence epidemic."

"In the three weeks since we received FDA approval for Probuphine, we have trained over 800 Healthcare Providers who have already begun treating their patients with Probuphine," said Behshad Sheldon, CEO, Braeburn Pharmaceuticals. "We recognize the importance to both physicians and patients of this new treatment for opioid dependence and are working to train 5,000 healthcare providers before the end of the year.  We are currently conducting training sessions every weekend to accommodate the interest that has been expressed from qualified healthcare providers." 

For more information about training healthcare providers can visit www.ProbuphineREMS.com or call 1-866-397-8939. 

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 buprenorphine. The resulting construct is a solid matrix that is placed subdermally, 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. 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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