Buprenorphine

IntelGenx Updates Status of Buprenorphine Buccal Film ANDA

Retrieved on: 
Friday, April 5, 2024
Symantec Endpoint Protection, CRL, IGX, Chronic pain, Buprenorphine, TSX, FDA, Food, Pharmaceutical industry

SAINT LAURENT, Quebec, April 05, 2024 (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 its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.

Key Points: 
  • SAINT LAURENT, Quebec, April 05, 2024 (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 its resubmitted abbreviated new drug application (“ANDA”) for Buprenorphine Buccal Film.
  • The CRL includes a request for additional Pharmaceutical Quality information.
  • 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.

FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose

Retrieved on: 
Monday, April 8, 2024
General Health, FDA, Health, Pharmaceutical, Medical Supplies, Hypoventilation, Hypersensitivity, Nalmefene, Pulmonary edema, Caregiver, Safety, Tachycardia, Risk, New Drug Application, Patient, Ventricular tachycardia, Naloxone, Health care, Buprenorphine, Mortality, NDA, MD, Methadone, Ventricular fibrillation, Hypotension, Oxygen, LAAM, Recurrence, Allergy, Purdue University, Hypertension, Fentanyl, Pharmaceutical industry

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.

Key Points: 
  • Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
  • "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
  • Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

Retrieved on: 
Wednesday, March 27, 2024
Other Health, Research, General Health, Pharmaceutical, University, Education, Clinical Trials, Science, Biotechnology, FDA, Other Science, Health, Hypoventilation, Hypersensitivity, Nalmefene, IIR, Pulmonary edema, Doctor of Pharmacy, University of New Mexico, Safety, Tachycardia, Risk, Patient, Hydrogen chloride, Purdue Pharma, Naloxone, UNM, Emergency medicine, Ventricular tachycardia, Mortality, Buprenorphine, MD, Methadone, Emergency department, Ventricular fibrillation, Hypotension, Oxygen, HCI, ED, Hypertension, Recurrence, LAAM, Opioid overdose, Purdue University, Pharmaceutical industry

“We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”

Key Points: 
  • “We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”
    The prospective, randomized study, “Evaluation of Nalmefene HCl Injection for Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in an Emergency Department,” will compare the efficacy and safety of nalmefene HCl injection to naloxone injection in the treatment of recurrent respiratory depression due to opioid overdose.
  • 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.
  • Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.1 The Company distributes nalmefene HCl injection for no profit.
  • The study will be independently developed and carried out by UNM’s research team with Purdue Pharma providing only funding and nalmefene HCI injection.

Battling the opioid epidemic: New research shows access to opioid use disorder treatment in emergency rooms saves lives

Retrieved on: 
Tuesday, March 26, 2024
JAMA, EDS, American Medical Association, Survival, Addiction medicine, AHS, Patient, OUD, Journal, Research, Buprenorphine, Opioid use disorder, Emergency department, Drug, ED, Alameda Health System, Pharmaceutical industry

The research points to emergency rooms as critical gateways for providers to reach and treat patients with opioid use disorder.

Key Points: 
  • The research points to emergency rooms as critical gateways for providers to reach and treat patients with opioid use disorder.
  • Emergency departments are often the lowest-barrier access point for people seeking immediate health care.
  • This research shows that initiation of buprenorphine in the emergency department, combined with linkage to outpatient treatment, saves lives.
  • The Bridge Clinic at AHS is at the forefront of bringing opioid use disorder treatment to patients in Alameda County.

Collaboration with Ophelia Provides Highmark Wholecare Members Collaboration With Access to Opioid Use Disorder Treatment

Retrieved on: 
Wednesday, March 20, 2024
Psychiatry, Addiction medicine, Education, Patient, MAT, OUD, Travel, Buprenorphine, Prescription, Death, Opioid use disorder, Methadone, Drug, CDC, Medicaid, Medicare, Food, Fentanyl, Pharmaceutical industry

Ophelia has been part of Highmark Wholecare parent company Highmark Health's network in Pennsylvania since July 2021, serving 2.9 million commercial members.

Key Points: 
  • Ophelia has been part of Highmark Wholecare parent company Highmark Health's network in Pennsylvania since July 2021, serving 2.9 million commercial members.
  • In addition to treatment deserts and localized provider shortages, people with OUD tend to experience financial hurdles when seeking treatment.
  • "Highmark Wholecare's collaboration with Ophelia is helping course correct this crisis by providing access to comprehensive OUD care that our Medicaid and D-SNP members can receive quickly and safely."
  • "Our expanded collaboration with Highmark Health through Highmark Wholecare members allows us to serve communities that continue to be severely impacted by the opioid epidemic," said Zack Gray , CEO and co-founder at Ophelia.

Telehealth addiction treatment offers exceptional outcomes for pregnant people with opioid use disorder

Retrieved on: 
Thursday, March 14, 2024
ANN, Health, Patient, OUD, Research, Buprenorphine, Mortality, Opioid use disorder, Pregnancy, Small business, American College, Drug, MPH, Privacy, Mortal Kombat, Dietary supplement

ANN ARBOR, Mich., March 14, 2024 /PRNewswire-PRWeb/ -- Workit Labs, the research and development arm of Workit Health, today published a promising analysis of patients who were pregnant and received telehealth treatment for opioid use disorder. As opioid use disorder (OUD) is a growing risk factor for perinatal death, research in this field is increasingly vital.

Key Points: 
  • ANN ARBOR, Mich., March 14, 2024 /PRNewswire-PRWeb/ -- Workit Labs, the research and development arm of Workit Health, today published a promising analysis of patients who were pregnant and received telehealth treatment for opioid use disorder.
  • As opioid use disorder (OUD) is a growing risk factor for perinatal death, research in this field is increasingly vital.
  • It can be challenging for people who are pregnant and living with opioid use disorder to find addiction treatment.
  • "It can be extremely challenging for people who are pregnant and living with opioid use disorder to find addiction treatment," said Lira.

FORE Awards New Grant to Address Impact of Post-COVID Medicaid Policy Changes on Access to Treatment for Opioid Use Disorder

Retrieved on: 
Thursday, March 7, 2024
Opioid use disorder, Opioid, Drug, Risk, COVID-19, Buprenorphine, Organization, Policy, Patient, Pharmaceutical industry

“Medicaid is the single largest payer for opioid use disorder treatment and a lifeline for people who are often at the highest risk of overdose,” said Karen A. Scott, MD, MPH., president of FORE.

Key Points: 
  • “Medicaid is the single largest payer for opioid use disorder treatment and a lifeline for people who are often at the highest risk of overdose,” said Karen A. Scott, MD, MPH., president of FORE.
  • This latest grant builds on previous support RAND received from FORE for projects to understand the impact of policy changes for prescribing and accessing buprenorphine treatment during COVID-19.
  • FORE was founded in 2018 as a private 501(c)(3) national, grant-making foundation focused on addressing the nation’s opioid crisis.
  • FORE’s mission is to support partners advancing patient-centered, innovative, evidence-based solutions impacting people experiencing opioid use disorder, their families, and their communities.

Aegis Sciences Corporation Announces Its Adoption of Self-Regulatory Standards for NPS Testing

Retrieved on: 
Monday, February 5, 2024
Security, Data Management, Other Health, Technology, Consulting, Pharmaceutical, Professional Services, General Health, Other Technology, Science, Software, Data Analytics, Other Science, Health, Research, Bias, Intelligence, NPS, Senior, Polypharmacy, Drug overdose, Society, Patient, Pain, Forensic science, Laboratory, Death, Buprenorphine, CDC, Plasma protein binding, Opioid use disorder, Individual, OUD, Outline, Synthetic, Pharmaceutical industry

NPS, also known as designer drugs, are produced to simulate the effects of legal pharmaceuticals or existing controlled drugs and often go unidentified by routine presumptive or definitive drug testing methods.

Key Points: 
  • NPS, also known as designer drugs, are produced to simulate the effects of legal pharmaceuticals or existing controlled drugs and often go unidentified by routine presumptive or definitive drug testing methods.
  • The CFSRE and the SOFT NPS Committee’s recommendations for NPS were designed to assist laboratories seeking guidance on which NPS and other emerging drugs they should test.
  • The recommendations are developed with timely, national data and information from external collaborations and outline different tiers for inclusion in testing.
  • “Laboratories must be committed to staying current with methods for detection and confirmation of new compounds," said Dr. Rebecca Heltsley, Senior Vice President, Research and Development at Aegis Sciences Corporation.

Bicycle Health Publishes First-Ever Peer-Reviewed Research of Telehealth Treatment for Poppy Seed Tea Misuse

Retrieved on: 
Tuesday, January 9, 2024
Death, Seed, Patient, PST, Research, Drug, Male, OUD, Food, Journal, Opioid use disorder, Buprenorphine, Poppy, Opioid epidemic, Pharmaceutical industry

BOSTON, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Bicycle Health, the nation’s largest virtual provider of integrated medical and behavioral healthcare for opioid use disorder (OUD), published first-of-its-kind research in the Journal of Addictive Diseases detailing the effectiveness of telehealth treatment options for patients struggling with poppy seed tea (PST) use disorder.

Key Points: 
  • PST is a legally obtainable source of opiates made from the seeds of the opium poppy.
  • Some people prepare the tea specifically to elevate the opiate burden so that the consumable tea can be used recreationally.
  • PST has also emerged as a substitution for medication for opioid use disorder (MOUD) treatment when people cannot access prescription medications like buprenorphine .
  • The Bicycle Health study analyzed 18 patients treated for primary PST use disorder via Bicycle Health’s telehealth-based treatment model.

FORE Awards $900,000 in New Grants to Improve Access to Lifesaving Medications for Opioid Use Disorder in Pharmacies Nationwide

Retrieved on: 
Tuesday, December 5, 2023
Policy, Risk, Houston Community College, Pharmacist, Drug, Buprenorphine, Drug Enforcement Administration, University, University of Southern California, MPH, Patient, Organization, University of Rhode Island, Howard University, Opioid use disorder, Ground substance, Nursing

To improve access to medications for opioid use disorder, the Foundation for Opioid Response Efforts (FORE) today announced $900,000 in new grants.

Key Points: 
  • To improve access to medications for opioid use disorder, the Foundation for Opioid Response Efforts (FORE) today announced $900,000 in new grants.
  • The University of Rhode Island is receiving $455,797 to train pharmacists in Connecticut and Ohio to prescribe and dispense medications for opioid use disorder.
  • These latest grants continue FORE’s work to accelerate the ability of pharmacies to provide care to patients with opioid use disorder.
  • Since its founding in 2018, FORE has awarded grants totaling $40,113,091 to address the opioid and overdose crisis.