Buprenorphine hemiadipate

TUESDAY, May 30, 2023 -- The U.S. Food and Drug Administration has approved Brixadi (buprenorphine) extended-release injection to treat moderate-to-severe opioid use disorder . Brixadi is approved for both weekly (8 mg, 16 mg, 24 mg, 32 mg) and monthly (64 mg, 96 mg, 128 mg) subcutaneous injectable formulations, including lower doses that may be appropriate for people not able to tolerate higher doses of extended-release buprenorphine. Furthermore, the approved lower strength weekly formulation offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi can only be administered by health care providers in a health care setting through a Risk Evaluation and Mitigation Strategy program. The approval was based upon a randomized, double-blind, active-controlled clinical trial in 428 adults with a diagnosis of moderate-to-severe opioid use disorder. Patients were treated with weekly injections over 12 weeks and then transitioned to monthly injections for 12 weeks. The proportion of patients meeting responder criteria was 16.9 percent in the Brixadi group and 14.0 percent in the sublingual buprenorphine group. "Today's approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery," FDA Commissioner Robert M. Califf, M.D., said in a statement. "The FDA will continue to take the critical steps necessary to pursue efforts that advance evidence-based treatments for substance use disorders, which is a strategic priority under the FDA's Overdose Prevention Framework." Approval of Brixadi was granted to Braeburn. More Information Posted May 2023

Study evaluating efficacy of MODIA®, a digital therapeutic, in addition to clinician supervised medication-assisted treatment programs for individuals with opioid use disorder (OUD) The study enrolled 437 participants at 35 sites across the US Orexo brings deep category expertise to the research effort, having served the US OUD market extensively over the last nine years UPPSALA, Sweden, Oct. 28, 2022 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces the last participant has enrolled in the pivotal study of the digital therapeutic MODIA® as part of a clinician supervised medication-assisted treatment program for the treatment of opioid use disorder (OUD). The randomized, open-label, parallel-group study is evaluating whether the use of MODIA® in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce illicit opioid use. The study enrolled 437 participants at 35 sites across the US who voluntarily sought treatment for documented moderate to severe OUD. Orexo brings deep category expertise to the research effort, having served the US OUD market extensively over the last nine years through its efforts with ZUBSOLV® (buprenorphine and naloxone) sublingual tablets. "The medically assisted treatment of OUD requires a complete treatment plan that includes psychosocial support," said Nikolaj Sørensen, President and CEO of Orexo. "However, access to quality counselling remains one of the main barriers to successful treatment in many areas of the US. Our aim is to increase access to behavioural treatment to aid in the whole-person approach to overcoming OUD." The US opioid epidemic has claimed one million lives over the past two decades and is being driven by illicit opioids.[1] The opioid epidemic has worsened during the COVID-19 pandemic. More Americans died of drug overdoses in 2021 than any previous year, including more than 80,000 deaths involving opioids.[2] MODIA® has been co-developed with GAIA, a leading global DTx company based in Hamburg, Germany, which has over two decades of industry leading DTx evidence development across multiple therapeutic categories. In addition to GAIA's significant research experience and Orexo's expertise in OUD, patients with OUD were also included in the development and initial product testing of MODIA®, offering a highly unique patient perspective that drives the therapeutic experience. For further information please contact: Orexo AB (publ.) About MODIA® MODIA® is intended to provide digital cognitive behavioral therapy for patients with opioid use disorder (OUD), 18 years of age or older, as part of a clinician supervised medication-assisted treatment program for opioid use disorder (OUD). In addition, MODIA® helps users develop a customized relapse prevention plan based on the responses collected from the exercises throughout the program. Orexo who owns the global rights to MODIA® is aiming to get a prescription digital therapeutics clearance from the FDA, based on the results from the pivotal MODIA® study expected mid-2023 using the 510 K pathway. About the pivotal MODIA® study The pivotal, randomized, open-label, parallel-group study will evaluate whether the use of MODIA® in combination with sublingual buprenorphine/naloxone background therapy is superior to sublingual buprenorphine/naloxone alone to reduce opioid use. The study is designed to enroll an estimated 400 participants aged 18 to 65 across the US who are voluntarily seeking treatment for documented moderate to severe OUD. Participants will be evaluated over the course of 24 weeks, including a screening period where they will be stabilized on buprenorphine/ naloxone, with a primary endpoint defined as the subject having ≥80 percent of urine drug tests negative for opioids and negative self-reports for illicit opioid use during the study period. For more information about the study, please visit . About Orexo Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The main market today is the American market for buprenorphine/naloxone products, where Orexo commercializes its lead product ZUBSOLV® for treatment of opioid use disorder. Total net sales for 2021 amounted to SEK 565 million and the number of employees was 121. Orexo is listed on the Nasdaq Stockholm Mid Cap (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed. For more information about Orexo please visit . You can also follow Orexo on Twitter, @orexoabpubl, LinkedIn, and YouTube. The information was submitted for publication at 8.00 CET on October 28, 2022. [1] Centers for Disease Control and Prevention. (2022, October 21). Provisional Drug Overdose Death Counts. Centers for Disease Control and Prevention. . [2] Ibid The following files are available for download: SOURCE Orexo