PLYMOUTH MEETING, Pa., Dec. 23, 2018 /PRNewswire/ -- Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injections. The tentative approval is for use of BRIXADI for the treatment of 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. BRIXADI is administered only by healthcare providers (HCPs) in a healthcare setting and used as part of a complete treatment program that includes counseling and psychosocial support.

With tentative approval, FDA has concluded that BRIXADI has met all required quality, safety and efficacy standards necessary for approval, but is not eligible for marketing in the U.S. because of exclusivity considerations.

BRIXADI is a weekly and monthly subcutaneous injection that can be administered without the need for prior dose adjustment on oral buprenorphine or a loading dose. Patients currently being treated with other buprenorphine-containing products can start treatment with either BRIXADI weekly or BRIXADI monthly. A range of weekly and monthly dosing options offers HCPs the opportunity to individualize treatment for their patients, including weekly and monthly doses that provide plasma buprenorphine concentrations of ≥ 2 ng/mL for the entire dosing interval.

"With both weekly and monthly doses, BRIXADI supports current treatment guidelines that recommend frequent office visits, especially early in recovery when patients may discontinue treatment and there is a high risk of overdose," said Mike Derkacz, President and CEO of Braeburn. "Opioid overdose is the leading cause of death in the U.S for those under 50 years old, and both patients and the HCPs who care for them need additional options to manage this devastating chronic disease.

"Braeburn, and our partner Camurus, are currently reviewing FDA's tentative approval of BRIXADI and remain committed to taking appropriate actions with the goal of providing patients with OUD access to this much-needed, innovative long-acting treatment option as soon as possible," Mr. Derkacz added.

In a pivotal Phase 3 efficacy and safety trial evaluating the range of weekly and monthly doses, BRIXADI was titrated to effect in a blinded fashion. BRIXADI met the primary endpoint of non-inferiority for responder rate (p <0.001) versus daily sublingual buprenorphine/naloxone (SL BPN/NX). The trial included real-world patients: 26% tested positive for fentanyl prior to study randomization, 71% were using heroin at study initiation and 52% were using injectable opioids at study initiation. For the trial's key secondary endpoint, BRIXADI demonstrated superiority to SL BPN/NX in the percentage of negative opioid assessments from week 4 through 24 (p=0.004). BRIXADI is the only injectable buprenorphine studied against the standard of care (SL BPN/NX), with no opioid overdoses in patients receiving BRIXADI during clinical trials.

The safety profile of BRIXADI was generally consistent with the known safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common adverse reactions (occurring in ≥5% of patients) 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, which comprises a low volume lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the solution immediately starts transforming into a nanostructured liquid-crystalline gel allowing for a slow release of the buprenorphine at a continuous and steady rate over a one-week or one-month period. BRIXADI is delivered with a thin 23-gauge needle and administered in the buttock, thigh, stomach (abdomen) or upper arm. BRIXADI does not require refrigeration and therefore facilitates reduced storage logistics.

In 2017, roughly 11.4 million adults misused opioids in the U.S., according to the Substance Abuse and Mental Health Services Administration. OUD is a chronic brain disease in which patients have anatomic changes in areas of the brain that are critical to judgement, decision-making, and behavior control. With the signing of the SUPPORT Act in October of this year, the U.S. government has committed to improving access to effective, evidence-based treatment for patients with OUD.

The FDA's tentative approval of BRIXADI follows the recent approvals granted to Camurus for Buvidal® by the European Commission and the Australian Therapeutic Goods Administration in November 2018.

About Braeburn

Braeburn is dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. Our mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit www.braeburnrx.com.

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