Brixadi extended-release subcutaneous injection receives FDA approval for moderate to severe opioid use disorder
Braeburn announces that the FDA has approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (CIII), a new weekly and monthly medication for moderate to severe opioid use disorder (OUD) in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a transmucosal buprenorphine-containing product
Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support. Brixadi is to be administered only by healthcare providers in a healthcare setting and will be available in the U.S. in September 2023.
Brixadi is the first and only weekly and monthly subcutaneous injection for moderate to severe OUD and is the only buprenorphine injectable that utilizes FluidCrystal Injection Depot Technology. Patients currently being treated with oral buprenorphine-containing products can be switched to equivalent doses of Brixadi Weekly or Brixadi Monthly in accordance with the Prescribing Information for Brixadi.
“Today’s FDA approval of Brixadi is a significant step forward in the fight against OUD,” said Mike Derkacz, President and CEO of Braeburn. “Over the last three years the US experienced a significant increase in opioid overdoses in part related to the economic and social upheaval that negatively impacted all of us, especially people with opioid use disorder and people in recovery. Additional medication options for opioid use disorder will support healthcare providers in addressing the needs of their patients with opioid use disorder.”
Due to the risk of serious harm resulting from accidental intravenous (IV) administration, Brixadi has a Boxed Warning and will be made available through a restricted distribution program called the Brixadi Risk Evaluation and Mitigation Strategy (REMS). Healthcare settings and pharmacies that order and dispense Brixadi must be certified in this program and comply with the REMS requirements. Information on the BRIXADI REMS program will be available at www.BRIXADIREMS.com.
Brixadi is the only injectable buprenorphine studied against sublingual buprenorphine/naloxone (SL BPN/NX) in a 24-week Phase III, double-blind study, which randomized 428 adults with moderate to severe OUD. The trial enrolled patients representative of the real-world population, including patients that injected opioids (52%), patients that primarily used heroin (71%), patients with evidence of fentanyl use (26%) and patients using nonopioid substances at screening (71%). In this pivotal Phase III efficacy and safety trial, weekly and monthly Brixadi met the primary endpoint of non-inferiority for responder rate versus daily SL BPN/NX (16.9% vs. 14.0%, respectively; p<0.001). additionally, brixadi demonstrated superiority to sl bpn nx based on the cumulative distribution function (cdf) of the percentage of negative opioid assessments from week 4 through week 24 (p="0.004;" secondary endpoint).
“A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs,” said Dr. Michelle Lofwall, Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research and Primary Investigator in the Phase III efficacy and safety study. “Some patients need help with taking their medication as prescribed, some prefer not taking a daily medication or visiting a pharmacy to pick up their medication, so having a weekly and monthly option that provides buprenorphine over one week or one month could benefit patients, their loved ones and the treatment providers.”
The safety profile of Brixadi was consistent with the known systemic safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.
Brixadi is formulated using FluidCrystal Injection Depot Technology, allowing for a low volume pre-filled syringe. Upon injection and contact with fluids in the tissue, the solution transforms into a nanostructured liquid-crystalline gel allowing for a slow release of buprenorphine at a steady rate over a one-week or one-month period. Brixadi is delivered with a 23-gauge needle and may be administered in the buttock, thigh, stomach (abdomen) or upper arm. Brixadi does not require refrigeration.
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