Buprenorphine

IntelGenx Announces Receipt of Complete Response Letter from the FDA for Xiromed-Partnered Buprenorphine Buccal Film

Retrieved on: 
Thursday, April 27, 2023
Symantec Endpoint Protection, TSX, CRL, FDA, Buprenorphine, Chronic pain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Dietary supplement

SAINT LAURENT, Quebec, April 27, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the submitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

Key Points: 
  • SAINT LAURENT, Quebec, April 27, 2023 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC (“Xiromed”), has received a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding the submitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
  • Xiromed and IntelGenx will contact FDA to discuss the CRL and assess the filing of a request for reconsideration of the CRL.
  • Buprenorphine Buccal Film, which incorporates IntelGenx’s VersaFilm® technology in a novel formulation, is a generic version of Belbuca®, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
  • Approved by the FDA in 2015, Belbuca® is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

BayMark Opens New Treatment Centers for Opioid Use Disorder

Retrieved on: 
Wednesday, April 26, 2023
Residential treatment center, Opioid, Buprenorphine, Senior counsel, OH, COVID-19, Opioid use disorder, Fentanyl, Drug overdose, Heroin, OTP, MAT, Drug, Patient, Fortification, Methadone, Pharmaceutical industry

BENBROOK, Texas and PARMA HEIGHTS, Ohio, April 25, 2023 /PRNewswire-PRWeb/ -- The need for access to treatment for opioid use and other substance use disorders has unfortunately only grown in urgency over the last few years as the opioid epidemic was not only eclipsed but exacerbated by the COVID-19 pandemic. BayMark Health Services has continued to expand services in response to this overwhelming need with the recent expansion of our MedMark Treatment Centers program locations for opioid use disorder in Texas and Ohio.

Key Points: 
  • BayMark Health Services has continued to expand services in response to this overwhelming need with the recent expansion of our MedMark Treatment Centers program locations for opioid use disorder in Texas and Ohio.
  • This week BayMark announced that its Fort Worth Opioid Treatment Program (OTP) has expanded into Benbrook, TX.
  • Located at 6240 Southwest Blvd, the location provides treatment with methadone or buprenorphine medications, laboratory services and health screenings.
  • MedMark Treatment Centers are known across the country as providers of comprehensive, individualized programs for adults struggling with opioid addiction.

Study: More Opioid Addiction Patients Stay in Treatment When Offered Buprenorphine via Telemedicine

Retrieved on: 
Wednesday, April 12, 2023
Male, Buprenorphine, Opioid use disorder, OUD, Research, Confidentiality, American Journal, Patient, Drug, Addiction, Mortality, Transport, American Journal of Drug and Alcohol Abuse, Geography, Health insurance, Nursing, Pharmaceutical industry, Medical device

The groundbreaking results point to the long-term promise of telehealth-based medication-assisted treatment for opioid use disorder (OUD).

Key Points: 
  • The groundbreaking results point to the long-term promise of telehealth-based medication-assisted treatment for opioid use disorder (OUD).
  • It also may be incredibly impactful for patients that traditionally had difficulties accessing care.
  • Published in late March 2023 in The American Journal of Drug and Alcohol Abuse , the study spanned 1,378 patients.
  • Despite the availability of effective and lifesaving medications such as buprenorphine, the majority of individuals with OUD in the US go without treatment.

Purdue Pharma L.P. to Provide Funding Opportunities for Investigator-Initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

Retrieved on: 
Tuesday, March 28, 2023
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Vitae, Hypersensitivity, IIR, Medical Affairs Bureau, Doctor of Pharmacy, Naloxone, Curriculum vitae, Hypotension, Buprenorphine, Safety, Oxygen, LAAM, Purdue Pharma, Tachycardia, Hypertension, Nalmefene, Ventricular tachycardia, Patient, Hypoventilation, Risk, Methadone, Pulmonary edema, Knowledge, Mortality, Ventricular fibrillation, Letter, Recurrence, Curriculum, Pharmaceutical industry, Cereal, Birth control

Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL).

Key Points: 
  • Purdue Pharma L.P. is accepting proposals for investigator-initiated research (IIR) to examine the outcomes associated with the use of Nalmefene Hydrochloride injection, 2mg/2mL (1mg/1mL).
  • Nalmefene HCl injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected opioid overdose.1 The Company distributes Nalmefene HCl injection for no profit.
  • “We look forward to supporting continued exploration of real-world use of Nalmefene HCl injection through these research efforts,” said Monica Kwarcinski, PharmD, Vice President, Medical Affairs at Purdue Pharma.
  • Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.

HMP Global's Rx Summit brings federal, state, local officials together to address drug misuse crisis; topics include Xylazine, X-Waiver, Naloxone, Predictive Analytics

Retrieved on: 
Wednesday, March 22, 2023
Learning, Substance Abuse, Xylazine, Prohibition, Medicaid, Senior, Methamphetamine, Information technology, Naloxone, MATE, Buprenorphine, Public, Law enforcement, Opioid use disorder, Standing, Substance Abuse and Mental Health Services Administration, Strategic Education, Inc., DATA, United States drug overdose death rates and totals over time, Social, Dentist, Pharmacist, Operation, Cocaine, Drug, Physician, Nursing, Psychological abuse, Artificial intelligence, Mental health service, FDA, Conference, Treatment, Education, Counselor, Pharmaceutical industry, Cryptocurrency, Medical device

MALVERN, Pa., March 22, 2023 /PRNewswire-PRWeb/ -- As xylazine-related overdose deaths become increasingly prevalent, accounting for as many as 25% of all overdoses in some states and as communities throughout the country continue to fight the wave of drug misuse cases, stakeholders will gather for the 2023 Rx and Illicit Drug Summit, the largest annual gathering focused on best practices for drug misuse prevention, treatment and recovery.

Key Points: 
  • Organized by the leading healthcare events and education company HMP Global, the 12th annual Rx Summit will be held April 10-13 at the Georgia World Conference Center in Atlanta.
  • "The work done at Rx Summit since it began in 2012 has never been more important as it is this year, when overdoses are occurring at record rates.
  • Our nation needs healing and Rx Summit is where it all begins."
  • Rx Summit is the largest national collaboration of professionals from local, state, and federal agencies, business, academia, treatment providers, and allied communities impacted by prescription drug misuse and illicit drug use.

Clinicians Identify Buprenorphine “Spiking” In JAMA Psychiatry Study Supported by Millennium Health Researchers

Retrieved on: 
Wednesday, March 22, 2023
Pharmaceutical, Science, Health, Research, Spiking, Doctor of Pharmacy, Buprenorphine, University, Urine, UDT, Department of Medicine – University of Pamplona, Opioid use disorder, OUD, Doctor of Philosophy, Pain, University of Colorado School of Medicine, MHS, Public health, Patient, Immunoassay, Johns Hopkins Bloomberg School of Public Health, JAMA Psychiatry, Pharmaceutical industry, MD

Spiking a urine sample represents intentional addition of buprenorphine tablet or residue directly into the urine to mimic adherence with prescribed buprenorphine.

Key Points: 
  • Spiking a urine sample represents intentional addition of buprenorphine tablet or residue directly into the urine to mimic adherence with prescribed buprenorphine.
  • Detecting spiking allows clinicians to adjust or intensify the treatment plan.”
    “At Millennium Health we have been tracking the enormity of the drug use crisis.
  • This study suggests that spiking is an important patient safety issue, and it is not uncommon,” said study co-author Eric Dawson, PharmD, VP of Clinical Affairs, Millennium Health.
  • Immunoassay based, point-of-care tests cannot detect spiking because they are generally incapable of quantitative analysis and differentiating buprenorphine from norbuprenorphine.”

New Study from Bicycle Health shows tele-OUD treatment associated with reductions in patient risks for relapse

Retrieved on: 
Thursday, March 16, 2023
BAM, Conference, Philippine Drug Enforcement Agency, Patient, Addiction medicine, Opioid use disorder, Protective factor, Social Problems, OUD, Health, Risk, FDA, Drug, Buprenorphine, DEA, Telehealth, Opioid, Pharmaceutical industry, Research, Bicycle

The study, presented by Bicycle Health Data Analyst, Barbara Burke, found that, within the first 30 days of treatment with Bicycle Health, patients’ risks for relapse as well as drug and alcohol usage were reduced.

Key Points: 
  • The study, presented by Bicycle Health Data Analyst, Barbara Burke, found that, within the first 30 days of treatment with Bicycle Health, patients’ risks for relapse as well as drug and alcohol usage were reduced.
  • Key findings from the research include:
    Less Substance Usage: Bicycle Health patients reported less use of drugs and alcohol during their first 30 days of tele-OUD treatment.
  • cravings, engagement with risky situations, social problems, physical health, sleep mood) when accessing treatment via Bicycle Health’s tele-OUD model.
  • “Bicycle Health remains committed to ensuring our patients are receiving science-backed, effective care for their OUD that meets them wherever they are,” said Ankit Gupta, CEO and founder of Bicycle Health.

FORE Awards $2 Million in New Grants to Improve Access to Medications for Opioid Use Disorder in Pharmacies and Emergency Departments

Retrieved on: 
Wednesday, March 8, 2023
United States drug overdose death rates and totals over time, Howard University Hospital, University of Kentucky College of Pharmacy, Pharmacist, Drug, Opioid use disorder, Massachusetts General Hospital, Swiss Tropical and Public Health Institute, University, Howard University, Fellow of the American College of Emergency Physicians, MPH, National Association, Patient, National Association of Boards of Pharmacy, School, Naloxone, Organization, Prescription, American College, Stigma, Houston Community College, Emergency medicine, Emergency, Buprenorphine, Nursing, Pharmaceutical industry, MD, Pharmacy

Since its founding in 2018, FORE has awarded grants totaling $33.9 million to address the national crisis.

Key Points: 
  • Since its founding in 2018, FORE has awarded grants totaling $33.9 million to address the national crisis.
  • “Pharmacies and emergency departments have a vital role in ensuring that patients receive the medications they need in a timely manner.
  • Black residents of lower-income areas of Washington, DC, are disproportionately affected by opioid use disorder and overdose deaths yet have limited access to medications for opioid use disorder in their communities.
  • This latest grant continues FORE’s work to accelerate the ability of the nation’s emergency departments to fight the opioid crisis.

Bicycle Health and Wellpath Team Up to Provide Opioid Use Disorder Treatment to Federal Bureau of Prisons

Retrieved on: 
Thursday, February 23, 2023
Death, SDOH, Substance Abuse, MD, Substance Abuse and Mental Health Services Administration, FBOP, Federal Bureau of Prisons, Opioid use disorder, Buprenorphine, Recidivism, FDA, Rough, Mental health service, Patient, RRC, Psychotherapy, OUD, Medication, Health, Rehabilitation, Nursing, Wellpath

The Substance Abuse and Mental Health Services Administration has found that MOUD treatment regimens are significantly underutilized in criminal justice settings.

Key Points: 
  • The Substance Abuse and Mental Health Services Administration has found that MOUD treatment regimens are significantly underutilized in criminal justice settings.
  • The collaboration between Bicycle Health and Wellpath will provide improved access to MOUD in RRCs across 42 states, with plans to expand.
  • Bicycle Health and Wellpath plan to grow the service to meet the recovery needs of formerly incarcerated patients – to improve their health, the overall health of the community, and reduce recidivism.
  • “Telehealth is now well understood to be a widespread, highly effective treatment delivery option for patients with opioid use disorder, which is why we chose to work with Bicycle Health.

Jovive Health Launches New Medication-Assisted Treatment Services

Retrieved on: 
Monday, February 13, 2023
DO, American Society of Addiction Medicine, MAT, Drug, Neurochemistry, OUD, Buprenorphine, Medicine, Patient, Substance abuse, FDA, Society, Opioid, Addiction medicine, Nursing, Pharmaceutical industry

MAT with buprenorphine decreases the physical symptoms of opioid withdrawals and cravings, enabling patients to safely stop using opioids.

Key Points: 
  • MAT with buprenorphine decreases the physical symptoms of opioid withdrawals and cravings, enabling patients to safely stop using opioids.
  • Jovive Health clinics offer convenient access to comprehensive primary and urgent care services with extended hours and telehealth appointments.
  • New patients enroll in a multi-appointment MAT program that is designed to stabilize symptoms and develop an individualized treatment plan.
  • Treatment may be covered by a health plan but is also available at a reasonable out-of-pocket cost.