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Naltrexone injections could reduce risk of relapse among opioid dependent individuals

Naltrexone injections could reduce risk of relapse among opioid dependent individuals

In a multicenter, randomized clinical trial, ex-prisoners who received six monthly injections of naltrexone--a long-acting medication that blocks opioid receptors in the brain--were significantly less likely to resume opioid use than those who received counseling and referrals to community treatment centers without naltrexone. [More]
First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

First patient enrolled in Phase 3 efficacy trial of CAM2038 for opioid dependence

Braeburn Pharmaceuticals and Camurus announce that the first patient has been randomized in the double blind Phase 3 efficacy trial of CAM2038 in opioid-dependent patients. CAM2038 medications are designed for long-acting weekly and monthly administration. [More]
Women need different treatment from men with addiction, says McMaster University-led study

Women need different treatment from men with addiction, says McMaster University-led study

Painkillers prescribed by doctors are the starting point for an opioid addiction for more than half of female methadone clinic patients, and they need different treatment from men with addiction, says a study led by McMaster University researchers. [More]
Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Braeburn, Camurus announce FDA Fast Track designation for CAM2038 to treat opioid addiction

Braeburn Pharmaceuticals and Camurus announced today that the U.S. Food and Drug Administration granted Fast Track designation for the CAM2038 weekly and monthly buprenorphine subcutaneous injection products under development for the treatment of opioid addiction. [More]
BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BioDelivery Sciences International, Inc. announced that the U.S. Food and Drug Administration has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL (buprenorphine and naloxone) buccal film (CIII). [More]

FDA accepts Braeburn's resubmission of Probuphine NDA for review

Braeburn Pharmaceuticals, an Apple Tree Partners company, today announced that the U.S. Food and Drug Administration has accepted Braeburn's resubmission of the Probuphine New Drug Application (NDA) for review and set February 27, 2016 as the target date for Agency action. [More]
Variations in opioid receptor genes linked to neonatal abstinence syndrome severity in newborn babies

Variations in opioid receptor genes linked to neonatal abstinence syndrome severity in newborn babies

A new study led by researchers at Boston Medical Center indicates that variations in opioid receptor genes are associated with more severe neonatal abstinence syndrome (NAS) in newborn babies. The findings, published online in Drug & Alcohol Dependence, could help lead to the development of individualized treatment plans tailored to each infants' risk of requiring medication to curb their NAS symptoms, which could help improve these patients' outcomes and reduce how long some stay in the hospital. [More]
BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. [More]
People across the world are living longer but spending more time in ill health

People across the world are living longer but spending more time in ill health

People across the world are living longer but spending more time in ill health as rates of nonfatal diseases and injuries - including diabetes and hearing loss - decline more slowly than death rates, according to a new analysis of 301 diseases and injuries in 188 countries. [More]
Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn reports positive topline results from Probuphine Phase 3 study for treatment of opioid addiction

Braeburn Pharmaceuticals, an Apple Tree Partners company, today reported positive topline results from the Phase 3 double-blind, double-dummy clinical study of Probuphine, the investigational subdermal implant containing buprenorphine HCl for the long-term maintenance treatment of opioid addiction. [More]
BioDelivery Sciences secures additional $20.7M in gross debt funding from MidCap Financial

BioDelivery Sciences secures additional $20.7M in gross debt funding from MidCap Financial

BioDelivery Sciences International, Inc. announced today that it has secured an additional $20.7 million in gross debt funding from MidCap Financial to bring BDSI's total outstanding debt with MidCap to $30 million in a single senior secured loan. [More]
BioDelivery Sciences calls for new treatment options for opioid addiction

BioDelivery Sciences calls for new treatment options for opioid addiction

As the rate of opioid abuse soars to new levels, growing recognition of the problem is garnering unprecedented media attention—as well as motivating innovative new approaches to better treatment. [More]
Total costs of treatment for babies with neonatal abstinence syndrome on the rise

Total costs of treatment for babies with neonatal abstinence syndrome on the rise

As more infants are born to mothers with dependence on prescription pain medications, the costs of treatment for babies with neonatal abstinence syndrome (NAS) have increased dramatically, suggests a report in the March/April issue of the Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine. [More]
Indivior reports top-line results from RBP-7000 phase 3 trial for treatment of schizophrenia

Indivior reports top-line results from RBP-7000 phase 3 trial for treatment of schizophrenia

Indivior PLC today announced top-line results from its phase 3 clinical trial of RBP-7000, an investigational drug in development for the treatment of schizophrenia. In this pivotal study, both doses of RBP-7000 tested, 90 mg and 120 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in the symptoms of acute schizophrenia over an 8-week treatment period. [More]
Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

Clonidine Topical Gel fails to meet primary endpoint in Phase 3 study for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced that the primary efficacy endpoint in the Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of painful diabetic neuropathy did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. In addition, a strong safety profile for the product was observed. [More]
Actavis obtains final approval from FDA for generic Subutex

Actavis obtains final approval from FDA for generic Subutex

Actavis plc today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (Buprenorphine 2 mg and 8 mg sublingual tablets). [More]
Orexo announces positive results from ISTART/006 study

Orexo announces positive results from ISTART/006 study

Orexo US, Inc. announced results from the ISTART/006 study, being presented today at the 25th Annual Meeting and Symposium of the American Academy of Addiction Psychiatry in Aventura, Florida, USA. [More]
Month-long residential program helps young adults stay drug-free

Month-long residential program helps young adults stay drug-free

Residential treatment may be an appropriate first-line option for young adults who are dependent on opioid drugs - including prescription painkillers and heroin - and may result in higher levels of abstinence than does the outpatient treatment that is currently the standard of care. [More]
Buprenorphine maintenance therapy better than detoxification for treating prescription opioid dependence

Buprenorphine maintenance therapy better than detoxification for treating prescription opioid dependence

For treating patients with prescription opioid dependence in primary care, buprenorphine maintenance therapy is superior to detoxification, according to a new study by Yale School of Medicine researchers published in the Oct. 20 issue of JAMA Internal Medicine. [More]

RAND study: Specific state guidance can influence patient access to effective heroin treatment

State policies can influence the number of physicians licensed to prescribe buprenorphine, a drug that can treat addiction to heroin and other opioids in outpatient settings, according to a new RAND Corporation study. [More]
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