After Brixadi Approval, Braeburn Ramping Up Hiring for Commercial Launch
By Mark Terry
May 25, 2023
The U.S. Food and Drug Administration approved Braeburn’s Brixadi (buprenorphine) extended-release injection to treat moderate to severe opioid use disorder (OUD). The company, based in Plymouth Meeting, Pa., plans to launch the drug in the U.S. in September, and as a result, has already begun extensive hiring.
“The drug is a formulation of buprenorphine, which is a medicine that’s already known to be very effective for treating opiate use disorder,” Michelle Lofwall, MD, Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research and Primary Investigator of Braeburn’s Phase III trial, told BioBuzz. “The drug takes buprenorphine and puts it into a subcutaneous weekly injection and a monthly injection in different doses.”
The Substance Abuse and Mental Health Services Administration (SAMHSA) indicates that patients with OUD who take buprenorphine slash their risk of death from all causes in half. The most common use of buprenorphine is a once-daily sublingual dose. The option of a weekly or even monthly dose because the drug must be given in a medical setting, creates significantly more convenience for patients.
Lofwall said, “So patients that have opiate use disorder can receive either a weekly injection that basically gives buprenorphine coverage over a weekly or monthly injection. It’s an injection that goes underneath the skin, into the arm, leg, thigh or belly. It’s a small volume, so it’s not a large injection. In addition, this formulation doesn’t need to be refrigerated, which makes it a little easier to store than our current monthly product.”
The approval was based on a 24-week Phase III, double-blind study of 428 adults with moderate to severe OUD. The trial enrolled patients representative of real-world populations, including ones that injected opioids, used heroin, had evidence of fentanyl use and patients using nonopioid substances. Brixadi is the only injectable formulation studied directly against sublingual buprenorphine/naloxone.
Lofwall said, “There was no significant difference between the two groups on the primary outcome. That’s really good because we had an active control and we want to have more options, not less.”
Mike Derkacz, President and CEO of Braeburn, notes that the drug is marketed outside the U.S. by Swedish company Camurus. The company’s technology, FluidCrystal® Injection Depot, provides treatment efficacy over extended periods from a single injection. “It’s a nanoparticle technology that forms a crystalline depot just under the skin and delivers buprenorphine over a period of either seven or 28 days, depending on whether the patient had the weekly or monthly formulation. It’s a highly efficient technology and enables room-temperature storage, which is very important from a clinician and logistics standpoint,” Derkacz said.
Buprenorphine was developed in the late 1960s and is a schedule III drug, meaning there is some potential for moderate or low physical dependence or high psychological dependence. The idea is that after being treated with buprenorphine, the individual then decreases its use, eventually allowing a break from opioid addiction with minimal withdrawal symptoms.
Lofwall emphasizes, “This is a real, legitimate medical illness. This is a medication that’s in a different formulation, but the medication itself, buprenorphine, reduces death, morbidity and mortality. It’s really needed. We need more options for our patients and to get the drug to more patients and settings.”
Braeburn is “exclusively focused on addressing the opioid overdose crisis in America,” Derkacz told BioBuzz. “We have one product which has two formulations, both a weekly and a monthly injectable form of buprenorphine. We are explicitly focused on addressing and meeting the needs of those patients.”
With the recent approval, the company is in high gear, building out its sales, marketing and educational infrastructure for a September 2023 launch. The FDA requires the drug to be available via a Risk Evaluation and Mitigation Strategy (REMS) program, meaning it will only be administered by healthcare providers in a specialized healthcare setting that has been certified and must comply with REMS requirements..
“We are in the process of hiring our field team now,” Derkacz said. “We are essentially not only hiring those individuals, but we will also be training and preparing them for the September launch. It’s a multi-faceted field team comprised of a number of key account managers, regional business specialists, regional directors, medical science liaisons and various personnel who can assist with the specialty pharmacies and special distributors we have in place.”
The hiring will be broad across the U.S., although Derkacz notes that they are “putting in place a plan meant to focus where the disease is at its worst. So we have an infrastructure to meet the needs of the patients suffering from opioid use disorder the most.”
The company is based squarely in the middle of the Philadelphia region. Derkacz points out that the opioid use epidemic and overdose crisis, although national, has been “largely concentrated in the Northeast and mid-Atlantic area. Of course, we will have infrastructure meant to address those issues and those needs in those specific areas.”
In December 2022, President Biden signed a multipart appropriations bill that included the bipartisan Mainstreaming Addiction Treatment (MAT) Act. This included making buprenorphine more readily accessible to patients. Part of the MAT Act eliminated some of the difficulties in prescribing and worked to make the drug more available to historically underserved communities.
“What this means,” Derkacz said, “is that before January 1 of this year, physicians were restricted or limited to the number of patients they could treat with buprenorphine. That also means that opioid use disorder is now considered more of a true chronic disease, which is an important step for these patients because there is a meaningful stigma they face in terms of getting access to appropriate treatment. So we hope this is one key step in helping patients who need treatment to actually get that appropriate treatment.”
Currently, the company is completely focused on a successful launch of Brixadi. Derkacz said, “If you look at successful biotech companies over the years, every company starts with one successful launch. Once that successful launch is achieved, it usually opens new doors, new opportunities for other assets, other opportunities from a portfolio and pipeline standpoint.”
As a result, they are intensely focusing their efforts on making the Brixadi launch as successful as possible.
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Mark Terry is a freelance writer, editor, novelist and ghostwriter. He holds a degree in microbiology & public health and spent 18 years in infectious disease research and clinical and research genetics prior to his transition to a writing career. His areas of expertise include biotechnology, pharma, clinical diagnostics, and medical practice management. He has written literally thousands of articles, as well as market research reports, white papers, more than 20 books, and many other written materials. He currently lives in Michigan with his family.
