Opioid Dependence News and Research

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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.

13 Aug 2015

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.

9 Jun 2015

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.

8 Jun 2015

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.

1 Jun 2015

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.

30 May 2015

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.

20 May 2015

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.

5 May 2015

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.

30 Mar 2015

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).

21 Feb 2015

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.

7 Dec 2014

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.

21 Nov 2014

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.

21 Oct 2014

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.

8 Oct 2014

Low dose of opioids including methadone effective for treatment of testosterone suppression

Treatment for opioid addiction tampers with the testosterone levels of male but not female opioid users, McMaster University research has shown.

26 Aug 2014

BioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN treatment

BioDelivery Sciences International, Inc. announced today that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).

6 Aug 2014

Actavis seeks FDA ANDA approval for generic Zubsolv, confirms patent challenge

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, Eq, 1.4 mg/0.36 mg and 5.7 mg/1.4 mg Base. Actavis' ANDA product is a generic version of Orexo's Zubsolv, which is a partial opioid agonist indicated for the maintenance treatment of opioid dependence.

30 Jun 2014

Use of opioid linked to higher levels of dissatisfaction following spine surgery

A new study appearing in the Journal of Bone and Joint Surgery (JBJS) links the use of opioid pain relievers (prescription medications, such as Percocet) to less improvement and higher levels of dissatisfaction following spine surgery.

13 Jun 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Orexo US partners with inVentiv Health to market Zubsolv sublingual tablets in the US

Orexo AB announces a new partnership between Orexo US, Inc. and inVentiv Health for the commercialization of Zubsolv in the US.

20 May 2014

Study: Wider use of medications may help reduce substance abuse, related hospital admissions

A comparatively new form of a medication for alcohol and opioid dependence that's injected once a month instead of taken orally once a day appears to be significantly more effective than some other medications - because more patients actually continue the prescribed regimen.

15 May 2014