~ Weekly and monthly buprenorphine for patients previously on long-term daily opioid therapy ~
80% of adults experience low back pain at some point in their lifetimes, according to the National Institute of Neurological Disorders and Stroke, part of the NIH. It is the most common cause of job-related disability and a leading contributor to missed work days. In a 2016 analysis published in the Journal of the American Medical Association, a group of researchers led by Joseph L. Dieleman, PhD, of The Institute for Health Metrics and Evaluation—the independent population health research center at the University of Washington founded by The Bill and Melinda Gates Foundation—concluded that low back and neck pain accounted for the third-highest amount of US health care spending at $87.6 billion annually.
Opioids such as codeine, oxycodone and morphine are among the most commonly prescribed medications to treat chronic low back pain. Treatment can frequently lead to addiction and severe side effects including drowsiness, constipation, decreased reaction time, impaired judgment and aggravated depression. According to the National Institute on Drug Abuse, 116 people in the US die every single day after an opioid overdose, while the total economic burden of prescription opioid misuse is $78.5 billion per year.
Source: Braeburn
Braeburn shows statistically significant improvement in pain intensity
Plymouth Meeting, Pennsylvania, based Braeburn announced positive top-line results today from its Phase 3 study of its injectable buprenorphine formulation, CAM2038, for the treatment of moderate-to-severe chronic low back pain in patients previously on long-term daily opioid therapy. CAM2038 is a weekly and monthly subcutaneous depot injection of buprenorphine, which has been on the market since 2002 for the treatment of opioid addiction. Buprenorphine is an opioid partial agonist, which activates the brain’s opioid receptors but to a much lesser degree than a full opioid. Buprenorphine also acts as an opioid partial antagonist, blocking other opioids. Braeburn currently markets Probuphine, an implantable formulation of buprenorphine, which was approved by the FDA in 2016 for the maintenance treatment of opioid addiction.
The Phase 3 study met the primary endpoint of “Average Pain Intensity,” showing that patients with chronic low back pain experienced statistically significant reduction in pain when treated with CAM2038 vs placebo. Furthermore, the key secondary endpoint of “Worst Pain Intensity” also demonstrated statistical significance. For both endpoints, the “effect size” was greater than 1, meaning that the average person in the treatment group experienced greater than a full standard deviation of difference in pain compared to the average person in the placebo group.
Patients with chronic pain previously treated with opioids for an extended period of time may not have adequate pain relief and are in need of alternatives. If approved, CAM2038 offers an HCP [health care professional]-administered dosing regimen that will allow patients to transition from daily oral opioids to manage chronic pain, while potentially minimizing the risks of abuse, misuse and diversion.
– Mike Derkacz, President and CEO, Braeburn.
Will Braeburn revisit an IPO?
Braeburn filed to go public in December 2016 in a $150 million deal that would have valued the company at $575 million. That deal was ultimately withdrawn in February 2017, and Braeburn has made tangible progress since that time that would certainly raise the price tag if the company were to consider testing the IPO waters again.
- Mike Dercacz joined as President and CEO in June 2017 from Teva Pharmaceuticals
TEVA , where he was SVP and Head of Global Central Nervous System and Pain Therapeutic Areas. - In November 2017, the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038.
- Braeburn raised $110 million in a January 2018 mezzanine round led by Wellington Management that included Avista Capital, Deerfield Management, New Leaf Venture Partners, RA Capital Management and Rock Springs Capital. Apple Tree Partners, who had been the sole investor in Braeburn prior to this deal, also participated.
- In July 2018, the FDA assigned a PDUFA goal date of December 26, 2018, to rule on Braeburn’s New Drug Application for CAM2038.
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