product pipeline

Probuphine®

for the treatment of Opioid Addiction

Market completed
Market completed
Market completed
Market completed
Market in progress
Preclinical Phase 1 Phase 2 Phase 3 Market

Probuphine is a subdermal implant utilizing Titan's proprietary ProNeura drug delivery platform. Probuphine is the first and only product on the market for opioid addiction that provides non-fluctuating blood levels of buprenorphine around the clock for a period of six months following a single treatment procedure. The product is marketed in the U.S. by Braeburn Pharmaceuticals under a licensing agreement with Titan.

Key Benefits

Efficacy

Effective in reducing illicit opioid use

Compliance

Treatment with the ProNeura™ implant is expected to enhance patient compliance

Safety

Non-fluctuating drug exposure over six months may provide superior safety and tolerability

Ease of Use

Patients are dosed once every six months in an outpatient setting

Overview of

Opioid Addiction

What is Opioid Addiction?

Opioid addiction is a medical condition that is increasingly recognized as a global epidemic by world health authorities. Addiction is a primary, chronic disease of brain reward, motivation, memory and neurobiological circuitry. It is characterized by cravings, accompanied by a lack of impulse control, as well as cycles of relapse and remission. If left untreated, addiction is a progressive disease that often results in disability or premature death.

Current Treatments

Opioid addiction requires long-term treatment plans and medical care; abstinence is rarely a successful therapeutic approach. The current gold standard for medication assisted therapy (MAT) in the U.S. is buprenorphine. While sublingual buprenorphine is widely used as a treatment for opioid addiction, there are challenges with this option, including patient compliance, dosing that results in variable medication levels, and diversion and abuse associated with current daily medications.

Given the significant health epidemic of opioid addiction in the U.S., federal officials are seeking ways to ensure greater access to safe and effective treatments for the disease, while minimizing the risk of diversion and abuse. The U.S. Health and Human Services (HHS) Department recently announced that it will move to expand access to MAT by revising the regulations related to the prescribing of buprenorphine to treat opioid dependence. The current cap on the number of patients that can be treated with buprenorphine products by a physician limits the availability of this important medication assisted therapy. The HHS revision to the regulation will provide a balance between expanding the supply of buprenorphine-based treatment, encouraging use of evidence-based MAT, and minimizing the risk of drug diversion.

Treatment options that minimize the risk of abuse and diversion, such as Titan's Probuphine implant, could increasingly play a crucial role in the maintenance treatment of patients suffering from opioid addiction.

Opioid Dependence

Market Need

Buprenorphine dominates the current opioid addiction market

$2B

U.S. sales of daily oral formulations of buprenorphine, 2015

Since 2006

U.S. buprenorphine prescriptions have exceeded those of methadone

Challenges With Oral Buprenorphine That Probuphine can overcome
  • Patient compliance
  • Currently used sublingual dosing results in variable levels of medication in blood
  • Diversion and abuse associated with current daily dosed formulations

Clinical Studies

A final Phase 3 double-blind, double dummy clinical study of 177 patients met the pre-specified endpoint of non-inferiority as well as all secondary endpoints. Data from that trial also indicate that patients who were clinically stable on 8mg or less of buprenorphine per day maintained stability when transferred to Probuphine and were more likely to sustain abstinence from illicit opioids throughout the six months than those being treated with sublingual buprenorphine. Prior to the final Phase 3 trial, the efficacy and safety of Probuphine were studied in several other clinical trials, including a 163-patient, placebo-controlled study over a 24-week period (published in the Journal of the American Medical Association (JAMA)), and a follow on study of 287 patients (published in the journal Addiction).

The ProNeura Long-term, Continuous Drug Delivery Platform

ProNeura is designed to provide continuous drug release with non-fluctuating medication levels over a period of three months to a year. It is ideal for treating chronic diseases for which the maintenance of stable medication levels could offer advantages over other routes of administration.

Learn More About ProNeura

For Physicians

Physicians certified to prescribe buprenorphine products who would like more information about Probuphine or the certification process for prescribing Probuphine may contact Titan's commercialization partner Braeburn Pharmaceuticals Inc. here or may learn more at www.probuphineREMS.com.

Certification Process for Prescribing Probuphine

Braeburn Pharmaceuticals Inc. provides eligible health care providers with the necessary training and certification to prescribe Probuphine.

Training Includes

  • Information on Probuphine and selection of suitable patients
  • Proper methods for inserting and removing the Probuphine implant
  • Hands-on training using a meat simulation model

Medical Specialties of Physicians who are Certified to Prescribe Probuphine

  • Occupational medicine
  • Psychiatry
  • Internal medicine
  • OB/GYN
  • Family medicine
  • Anesthesiology
  • Surgery + subspecialties

Benefits of Probuphine

  • Lower risk of diversion
  • Greater adherence
  • Additional option for medication-assisted treatment (MAT)
  • Frequent travelers (No need for daily administration?)
  • Fewer office visits 

Patients are expected to begin treatment with oral buprenorphine formulations to determine their dosages before physicians can decide if Probuphine is the right treatment.