Braeburn develops next generation therapies for opioid use disorder and for chronic pain with individualized dosing regimens and delivery options.
In the Pipeline
CAM2028 is delivered by subcutaneous injection and provides a slow release of the drug over time, through a proprietary system known as FluidCrystal®. Braeburn's New Drug Application for CAM2038 weekly and monthly formulations for opioid use disorder was accepted with priority review designation by FDA. The New Drug Application for CAM2038 is under FDA review and if approved, will be marketed in the U.S. under a licensing agreement with Camurus.
Braeburn is also investigating CAM2038 in opioid dependent patients with chronic pain as part of its ongoing pivotal Phase III program.
FluidCrystal® Injection Technology
The proprietary FluidCrystal® delivery system used in the subcutaneous injection of CAM2038 includes a lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the lipid solution transforms into a crystalline gel, which effectively encapsulates the active ingredient, allowing for a slow release of the drug over time.
The FluidCrystal® delivery system offers benefits for the patient and the physician. Because the CAM2038 formulation is liquid, and the dose itself has a small volume, the injectable can be delivered with a thin 23-gauge needle, potentially improving the patient’s comfort during the treatment process which in turn encourages patient adherence. The dosage does not require refrigeration, and therefore facilitates both reduced storage logistics and increased ease of administration for the physician.
The New Drug Application for CAM2038 is under FDA review and if approved, will be marketed in the U.S. under a licensing agreement with Camurus.
Probuphine® (buprenorphine) implant is a six-month buprenorphine subdermal implant, approved by the FDA in May 2016. 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: Risk of migration, protrusion, expulsion, and nerve damage associated with insertion/removal of Probuphine® (buprenorphine). Please see Full Prescribing information, including Boxed Warning. Physicians who would like more information about Probuphine® (buprenorphine) or the certification process for prescribing Probuphine® (buprenorphine) may learn more at www.Probuphinerems.com.
Probuphine® (buprenorphine) is marketed in the U.S. under a licensing agreement with Titan Pharmaceuticals, Inc.
Braeburn is committed to supporting independent scientific research and independent medical education for the advancement of medical and scientific understanding in our therapeutic areas of interest.
Please note that Braeburn will not provide grant support for the following:
• Independent Medical Educational Grants directed to individuals
• Grants to support personal travel, travel fellowships or entertainment activities
• Grants for rewards or recognition
Note that no additional requests will be considered for 2017. Please check back again at a later date.