Braeburn Pharmaceuticals - Company of the Year

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Company: Braeburn Pharmaceuticals, Princeton, NJ
Entry Submitted By: Coltrin & Associates
Company Description: Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized 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.
Nomination Category: Company / Organization Categories
Nomination Sub Category: Company of the Year - Pharmaceuticals – Small

Nomination Title: Stopping the Opioid Addiction Epidemic with Innovation

Tell the story about what this nominated organization has achieved since January 1, 2016 (up to 650 words). Focus on specific accomplishments, and relate these accomplishments to past performance or industry norms.

The opioid addiction epidemic is seen by many, indeed most, as a moral failing rather than a chronic brain disease. People who suffer from this disease are called addicts rather than patients, and told to simply abstain rather than get help or seek treatment. Braeburn Pharmaceuticals sees this epidemic in a completely different light.

Braeburn is a company that delivers innovation through long-acting implants and injectables, eliminating the need for pills. This paradigm shifting approach will provide a continuum of treatments for serious neurological disorders such as opioid addiction, chronic pain, and schizophrenia. These chronic brain diseases are often deeply misunderstood and broadly stigmatized.

Braeburn’s progress is driven by the core belief that there exists a social justice solution to the opioid epidemic that is grounded in science and medicine – cutting edge, innovative treatment. With little innovation in the treatment of opioid addiction in the past 15 years and with the epidemic killing 91 people every single day, Braeburn’s innovative new treatments are extremely timely.

During the course of 2016, Braeburn made several advances in the treatment of opioid addiction in particular.

On May 26th, 2016, Braeburn received FDA approval for the first ever subdermal implant to treat opioid addiction, Probuphine®.

The media has declared Probuphine a ‘game changer.’

Current oral medications are clinically proficient, but do not necessarily meet the real world challenges and difficulties patients often face.

A patient can forget to take a pill each day or they may otherwise run out, lose it, and there are even cases where children accidentally ingest the medication. For opioid addicted patients, even missing one dose of medication can lead to relapse, and relapses are often fatal.

Probuphine helps patients avoid the above challenges. When a doctor prescribes Probuphine to a patient they know that the patient is receiving the exact dose of medicine prescribed. Not only is it comforting for doctors, it helps patients too because they never have to think about taking pills, relieving them of that burden and helping them to reduce pill-seeking or addictive behavior allowing them to lead a normal life.

Braeburn has several other innovative products that achieved important clinical milestones in 2016, including additional treatments for opioid addiction, chronic pain and schizophrenia.

One of the studies Braeburn completed was for CAM2038, (which the FDA has granted Fast Track status for priority review) a long acting injectable treatment for opioid addiction. CAM was compared head-to-head against a daily oral buprenorphine medication and there were four non-fatal overdoses during the course of the study with patients who were taking traditional oral medicine, whereas there were no overdoses and significantly fewer cases of relapse in the CAM2038 arm of the study.

Braeburn’s comprehensive vision for treating opioid addiction extends beyond the development of treatments for already addicted patients; Braeburn has also initiated phase III studies on CAM for the treatment of chronic pain. If successful, Braeburn will help countless patients by stopping addiction before it starts.

In the US alone, chronic pain is estimated to cost $560-635 billion annually, more than cancer and diabetes combined. The current standard of care for chronic pain is oral opioids, often taken multiple times a day. While some patients may successfully manage pain with opioid prescriptions, for many it is a risky proposition that all too soon leads to full blown opioid addiction.

Braeburn Pharmaceuticals’ team is fully invested and dedicated to the development of innovations that will transform the continuum of care for countless patients and stop the opioid epidemic in its tracks. Their products speak to the integrity of this company and through these products, they are truly contributing to the overall well-being of humankind.

In bullet-list form, briefly summarize up to ten (10) of the chief accomplishments of this organization since the beginning of 2016 (up to 150 words).

-Probuphine (buprenorphine) was approved by the FDA in May 2016, making it the first ever implant for opioid addiction.
-CAM2038, an injection to treat opioid addiction, is in phase 3 testing and Braeburn will be filing for FDA approval later this year.
- Probuphine was named a Gold award winner at the 13th annual Stevie Awards for Women in Business in the category of "Best New Product or Service of the Year".
-Probuphine data was Published in the Journal of the American Medical Association.
-Probuphine won Popular Science’s “Best of What’s New” Award in October 2016.
-Braeburn was named as a Top 10 Most Innovative Company in Biotech by Fast Company.

Of the following measures of success, which ONE do you want the judges to most appreciate about your organization's story of achievement since the beginning of 2016?

Overall Innovation