Buprenorphine

A first-of-its-kind trial studies the use of injectable buprenorphine to treat methamphetamine use disorder and opioid co-use

Retrieved on: 
Wednesday, June 28, 2023
University of Texas Southwestern Medical Center, University, Methamphetamine, Bridge program, Buprenorphine, Oklahoma State University Center for Health Sciences, AHS, Initiative, Quality of life, Hope, Alameda Health System, Wilma, Bangladesh Technical Education Board, CODA, MD, Patient, Outline of health sciences, National Institute on Drug Abuse, University of California, Los Angeles, HEAL, Research, FDA, NIH, King Hamad University of Nursing and Associated Medical Sciences, Pharmaceutical industry, Drug

"Many patients use opioids in addition to methamphetamine, and examining treatment options for people using multiple substances is particularly important."

Key Points: 
  • "Many patients use opioids in addition to methamphetamine, and examining treatment options for people using multiple substances is particularly important."
  • While buprenorphine has been used to treat opioid use disorder since 2002, there are currently no FDA-approved treatments for methamphetamine use disorder or methamphetamine use disorder together with opioid co-use.
  • The study is designated for those with moderate to severe methamphetamine use disorder coupled with mild opioid use disorder or opioid misuse.
  • "Using buprenorphine as a treatment for methamphetamine use disorder and opioid co-use is a promising option for this high-risk patient population.

Intelligent Bio Solutions Receives Guidance from U.S. FDA on a Regulatory Pathway for Expansion into the United States for its Intelligent Fingerprinting Drug Screening Cartridge

Retrieved on: 
Wednesday, June 28, 2023
Classification, Marketing, Benzodiazepine, Buprenorphine, Cocaine, Collection, Methadone, Cannabis, Substance abuse, Health, FDA, Intelligence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Medical device

NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced it has received guidance from the U.S. Food and Drug Administration (the “FDA”) regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge.

Key Points: 
  • NEW YORK, June 28, 2023 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced it has received guidance from the U.S. Food and Drug Administration (the “FDA”) regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge.
  • The Company intends to submit a 510(k) pre-market notification for its proprietary Intelligent Fingerprinting Drug Screening Cartridge.
  • “We are pleased to receive the FDA’s preliminary assessment for our Intelligent Fingerprinting Drug Screening Cartridge, which is a key step in our expansion into the U.S. market,” said Harry Simeonidis, President and CEO of Intelligent Bio Solutions.
  • The system features a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples are collected in less than a minute.

Over 40% of U.S. Pharmacies Report No Buprenorphine in Stock, According to New Peer-Reviewed Study from Bicycle Health Published in JAMA Network Open

Retrieved on: 
Wednesday, June 7, 2023
Drug, Substance Abuse, Partnership, Drug Enforcement Administration, Pharmacy, Gupta, Public, CVS, Opioid use disorder, OUD, Research, COVID, Upbeat, Journal of Substance Abuse Treatment, Journal, Outline, DEA, Patient, JAMA Network Open, United, MPH, News, JAMA, Pharmaceutical industry, Grocery store, Hospital, Walgreens, Buprenorphine, MD

Medications for opioid use disorder (MOUD) – including buprenorphine – are widely considered to be a gold-standard of care for OUD.

Key Points: 
  • Medications for opioid use disorder (MOUD) – including buprenorphine – are widely considered to be a gold-standard of care for OUD.
  • In spite of the success of MOUD with buprenorphine, access to the medication continues to be a challenge for patients and their providers.
  • Importantly, access to buprenorphine stock varied heavily depending on the state the patient resided in or type of pharmacy queried.
  • Buprenorphine availability was reported 59.7% and 70.3% of the time, respectively;
    Buprenorphine availability varied widely across the 32 states included in this study.

New Research Finds Telehealth to be a Safe and Effective Option For Those Undergoing Addiction Treatment in the Fentanyl Era

Retrieved on: 
Thursday, June 8, 2023
CDC, Annual, Opioid use disorder, MAT, OUD, Patient, Research, Fentanyl, HEDIS, Drug, Conference, Safety, Buprenorphine, Medical device

This study represents the largest known case series of its kind on the safety and feasibility of telehealth-guided home inductions.

Key Points: 
  • This study represents the largest known case series of its kind on the safety and feasibility of telehealth-guided home inductions.
  • Using chart reviews from December 2021 to November 2022, the research revealed that home-based buprenorphine inductions guided by telehealth are both feasible and well tolerated.
  • It was found that induction-related adverse events, predominantly seen in the fentanyl subgroup, were of mild-moderate severity and not associated with short-term treatment dropout.
  • This research proves the long-term benefits of telehealth-guided home inductions are just as feasible and as safe as office-based inductions."

Ophelia Expands Access to Opioid Addiction Treatment Across New York State, Now In-Network with MVP Healthcare

Retrieved on: 
Wednesday, May 24, 2023
ER, Partnership, Travel, Face, Senior counsel, Prescription, OUD, Brain, Privacy, MAT, Patient, Drug, Research, Pharmaceutical industry, Health insurance, Medicaid, Buprenorphine, Naloxone

NEW YORK, May 24, 2023 /PRNewswire/ -- Ophelia , an opioid addiction care provider, today announced a partnership with health insurer MVP Healthcare , further expanding access to its evidence-based medication-assisted treatment via telehealth across New York state.

Key Points: 
  • NEW YORK, May 24, 2023 /PRNewswire/ -- Ophelia , an opioid addiction care provider, today announced a partnership with health insurer MVP Healthcare , further expanding access to its evidence-based medication-assisted treatment via telehealth across New York state.
  • As a result of these partnerships, access to Ophelia is now available to MVP Healthcare's members in New York, including their Medicaid members.
  • Medicaid patients are historically underserved and face many hurdles to accessing high-quality and safe opioid use disorder (OUD) care services.
  • "Ophelia is dedicated to making lifesaving opioid addiction treatment more accessible to the people who need it most," said Zack Gray, Ophelia co-founder and CEO.

Camurus announces FDA approval of Brixadi™ for the treatment of moderate to severe opioid use disorder

Retrieved on: 
Wednesday, May 24, 2023
US Foods, Prevalence, Buprenorphine, SC, Senior counsel, Opioid use disorder, OUD, SL, Braeburn, CAMX, Patient, FDA, Food, Pharmaceutical industry, Camurus

Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.1 The product will be marketed in the US by Camurus' licensee Braeburn.

Key Points: 
  • Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.1 The product will be marketed in the US by Camurus' licensee Braeburn.
  • OUD is a complex and potentially life-threatening condition with a significant negative impact on the individual, their families, and society.
  • "Based on the success of Buvidal in Europe, Australia and other territories, we see a significant opportunity for Brixadi in the US," he continues.
  • The product is administered subcutaneously by a healthcare professional as a small volume injection (0.16-0.64 mL) in the buttock, thigh, stomach, or upper arm.

Camurus announces FDA approval of Brixadi™ for the treatment of moderate to severe opioid use disorder

Retrieved on: 
Wednesday, May 24, 2023
US Foods, Prevalence, Buprenorphine, SC, Senior counsel, Opioid use disorder, OUD, SL, Braeburn, CAMX, Patient, FDA, Food, Pharmaceutical industry, Camurus

Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.1 The product will be marketed in the US by Camurus' licensee Braeburn.

Key Points: 
  • Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.1 The product will be marketed in the US by Camurus' licensee Braeburn.
  • OUD is a complex and potentially life-threatening condition with a significant negative impact on the individual, their families, and society.
  • "Based on the success of Buvidal in Europe, Australia and other territories, we see a significant opportunity for Brixadi in the US," he continues.
  • The product is administered subcutaneously by a healthcare professional as a small volume injection (0.16-0.64 mL) in the buttock, thigh, stomach, or upper arm.

FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder

Retrieved on: 
Tuesday, May 23, 2023
Injection, REMS, Substance Abuse, Buprenorphine, Drug overdose, Education, Mitigation, Molina Healthcare, Senior counsel, Opioid use disorder, Skin, Substance Abuse and Mental Health Services Administration, Constipation, OUD, Urinary tract infection, Insomnia, Patient, Risk, Nausea, Drug, Diagnosis, FDA, Headache, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Factitious disorder, Counterfeit, Food, Safety, SAMHSA, Pharmaceutical industry, Vaccine

"Buprenorphine is an important treatment option for opioid use disorder.

Key Points: 
  • "Buprenorphine is an important treatment option for opioid use disorder.
  • Today's approval expands dosing options and provides people with opioid use disorder a greater opportunity to sustain long-term recovery," said FDA Commissioner Robert M. Califf, M.D.
  • After an initial test dose of transmucosal buprenorphine, patients were randomized to treatment with Brixadi plus a sublingual placebo, or active sublingual buprenorphine plus placebo injections.
  • A response to treatment was measured by urine drug screening and self-reporting of illicit opioid use during the treatment period.

Braeburn's BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder

Retrieved on: 
Tuesday, May 23, 2023
REMS, Mitigation, Pharmacy, Buprenorphine, Senior counsel, Health care, Opioid use disorder, OUD, SL, CIII, Heroin, Patient, Risk, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Vaccine, Pharmaceutical industry

PLYMOUTH MEETING, Pa., May 23, 2023 /PRNewswire/ -- Braeburn announces that the U.S. Food and Drug Administration (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.

Key Points: 
  • Patients currently on a transmucosal buprenorphine-containing product can be switched to an equivalent dose of BRIXADI Weekly or Monthly.
  • 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.
  • "Today's FDA approval of BRIXADI is a significant step forward in the fight against OUD," said Mike Derkacz, President and CEO of Braeburn.
  • Additional medication options for opioid use disorder will support healthcare providers in addressing the needs of their patients with opioid use disorder."

Workit Health Study Demonstrates High Retention In Rural Patients Receiving Telemedicine For Opioid Use Disorder

Retrieved on: 
Monday, May 22, 2023
Telehealth, Medicaid, ANN, Urine, Buprenorphine, Opioid use disorder, Prescription, Research, DEA, Patient, Drug, MPH, Pharmaceutical industry

ANN ARBOR, Mich., May 22, 2023 /PRNewswire-PRWeb/ -- Workit Labs, the research arm of Workit Health, the nation's leading provider of virtual substance use disorder treatment, is pleased to announce the publication of a groundbreaking study in the peer-reviewed journal Telemedicine and E-Health. This study represents the largest sample to date of American patients living in rural areas and receiving telemedicine for opioid use disorder. The findings demonstrate that telemedicine is an effective solution for rural populations living with opioid use disorder, addressing the challenges of accessibility and retention in treatment.

Key Points: 
  • This study represents the largest sample to date of American patients living in rural areas and receiving telemedicine for opioid use disorder.
  • The findings demonstrate that telemedicine is an effective solution for rural populations living with opioid use disorder, addressing the challenges of accessibility and retention in treatment.
  • The peer-reviewed study, titled "Retention in Telehealth Treatment for Opioid Use Disorder Among Rural Populations: A Retrospective Cohort Study," underscores the success of telemedicine in delivering treatment for opioid use disorder to individuals residing in rural communities.
  • For more information on the study and Workit Health's innovative telemedicine-delivered treatment for opioid use disorder, please visit https://www.workithealth.com .