Braeburn is developing long-acting medicines for treating opioid addiction.
Opioid addiction, also known as opioid use disorder (OUD) is a medical condition requiring medical treatment. Together with counseling and support, Braeburn’s next generation medicines allow patients to focus on the reintegration of their lives with their families and communities. Braeburn’s long-acting injectable and implantable formulations are administered directly by healthcare professionals. Therefore, healthcare professionals are able to maximize their patient’s adherence to their prescribed treatment while minimizing the potential risks of abuse and diversion of their medication.
Facing the Opioid Epidemic
Opioid addiction is the fastest growing public health crisis in America today.
- Opioid overdose is the leading cause of death for Americans under the age of 50.
- Each day in the US, 91 people die from opioid-related causes.
- More than 64,000 Americans died from drug overdoses in 2016, most involving a prescription painkiller or an illicit opioid like heroin.
- The true cost of the opioid drug epidemic in 2015 was $504 billion, or roughly half a trillion dollars, according to the U.S. Council of Economic Advisers.
- Women and adolescents are especially at risk for opioid addiction: women are more likely than men to be prescribed painkillers at higher doses and the use among adolescents is growing at an alarming rate according to the American Society of Addiction Medication (ASAM).
- In 2015, there were 690,000 OUD ICU admissions with an average cost of $92,400 per patient, totaling an average cost to payers of $63.8B.
OPIOIDS AND ADDICTION
Opioids are a class of drugs that interact with opioid receptors on nerve cells in the brain and nervous system to produce pleasurable effects and relieve pain. Opioids include heroin as well as the prescription pain relievers oxycodone, hydrocodone, codeine, morphine, fentanyl and others. Prescription painkillers are often necessary for treatment of acute and chronic pain, but with continued use the body can build physical dependence and tolerance.
Addiction is a primary, chronic and relapsing brain disease characterized by a person pathologically pursuing reward and/or relief by substance use and other behaviors, according to the ASAM. Addiction is a biological phenomenon not a moral failing.
Buprenorphine for medication-assisted treatment (MAT)
Buprenorphine is an FDA-approved medication that can help treat opioid addiction. It binds to opioid receptors and effectively blocks the signals from other opioids. It is proven to prevent cravings and withdrawal symptoms without an addictive high.
Today, patients have limited choices for treating their opioid addiction. They typically receive once-daily oral buprenorphine or buprenorphine/naloxone combination products (either tablets and sublingual film): formulations that are typically not administered by a physician and may be susceptible to abuse and diversion. These formulations are also highly susceptible to non-adherence: 58% of patients taking sublingual buprenorphine discontinue therapy within 30 days. Opioid-dependent patients who do not take at least 80% of their prescribed oral buprenorphine have over 10 times the risk of relapse than those who complete their prescribed course.
Braeburn’s next-generation, long-acting buprenorphine therapies
Braeburn has received New Drug Application acceptance and priority review designation from FDA for approval of the company’s long acting weekly and monthly buprenorphine formulations (CAM2038). If approved, CAM2038 weekly and monthly formulations of buprenorphine will enable healthcare providers to treat patients with long-acting buprenorphine from the first day of their treatment, and to customize and tailor ongoing treatment to their patients’ needs.
Promoting adherence, preventing diversion
Braeburn provides the healthcare provider with a flexible and customizable platform of addiction treatment medications that promote adherence and are expected to be less prone to abuse and diversion than daily addiction treatments.
Some injectables and implants may be less susceptible to abuse and diversion because they remain in healthcare provider control until administered.
Because the physician administers each dose, it is possible to achieve significant adherence during the prescribed dosage period. Braeburn’s weekly and monthly formulations are flexible and customizable: they can match the health care provider’s existing patient protocol and can be tailored to the needs of individual patients.
At Braeburn, we continually seek to reevaluate the way we work together to create an environment that redefines treatment for a vastly underserved patient population. Our core focus dedicated to advancing our pipeline of innovative treatments, but we also appreciate and accept our role as an emerging leader and voice in addiction and our other patient communities. We say that Braeburn thinks beyond what has been done…to imagine what can be done…and what is possible. For those who share this vision, we have created paths to help support and enable achieving what is possible.
Beyond our primary mission of investing in the clinical development and commercialization of our products and candidates, we may also choose to support community or healthcare programs which we consider consistent with our corporate mission and focus. Requests are considered on an individual basis and from US applicants only.
Note that no additional requests will be considered for 2018. Please check back again at a later date.