PLYMOUTH MEETING, PA — Braeburn announced recently that 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 buprenorphine, is now available in the U.S. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support.
BRIXADI is the first and only injectable buprenorphine for the treatment of moderate to severe OUD that offers weekly and monthly doses. Patients currently being treated with oral buprenorphine-containing products can be switched directly to either BRIXADI Weekly or BRIXADI Monthly in accordance with equivalent doses suggested in the Prescribing Information for BRIXADI.
“Opioid use disorder remains a public health crisis with over 82,000 people dying from an opioid overdose last year,” said Mike Derkacz, President and CEO of Braeburn. “We’ve remained committed to making another option available for healthcare providers to treat their patients with OUD, and the availability of BRIXADI is a significant milestone for Braeburn.”
BRIXADI is the only buprenorphine injectable that utilizes FluidCrystal®* Injection Depot Technology, allowing for a low volume pre-filled syringe with a thin needle. 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.
Due to the risk of serious harm resulting from accidental intravenous (IV) administration, BRIXADI has a Boxed Warning and is 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 is available at www.BRIXADIREMS.com.
“At Braeburn, we’re committed to transforming the treatment of OUD for patients, families and communities,” said Paul Johnson, Chief Commercial Officer at Braeburn. “BRIXADI is designed to align with how healthcare providers treat patients with OUD by offering multiple weekly and monthly dosing options to meet the patient where they are in their treatment journey. Healthcare providers and their patients with OUD will now have another FDA-approved option for long-acting, extended-release buprenorphine to address some of the challenges associated with the disease.”
The FDA approval of BRIXADI was based on a Phase 3, double-blind, active control (sublingual buprenorphine/naloxone) efficacy and safety study, and an opioid blockade study. BRIXADI is the only injectable buprenorphine studied against sublingual buprenorphine/naloxone (SL BPN/NX) in a 24-week Phase 3, 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 3 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) where patients were required to have negative opioid assessments at the end of each treatment phase. 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). In the opioid blockade study, BRIXADI demonstrated complete blockade of the subjective effects of an opioid that was sustained throughout the dosing intervals.
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 observed during clinical trials included injection-site pain, headache, constipation, nausea, injection-site erythema, injection-site pruritus, insomnia and urinary tract infections.
For additional information, see Full Prescribing Information including BOXED WARNING and Medication Guide at BRIXADI.com.
*FluidCrystal® is a trademark owned by Camurus and used under license by Braeburn.
**In patients who are not currently receiving buprenorphine treatment, for BRIXADI Weekly, the upper arm site should only be used after steady state has been achieved (4 weeks).
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