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

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. [More]
Use of opioid linked to higher levels of dissatisfaction following spine surgery

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. [More]
BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

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). [More]
Orexo US partners with inVentiv Health to market Zubsolv sublingual tablets in the US

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. [More]
Study: Wider use of medications may help reduce substance abuse, related hospital admissions

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. [More]
Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Braeburn announces new clinical trial for Probuphine based on clear guidance from FDA

Braeburn Pharmaceuticals announced today the initiation of a new clinical trial for Probuphine® based on clear guidance from the U.S. Food and Drug Administration (FDA). The study, which was submitted for FDA review in mid-March, is expected to begin enrollment by mid-year and to be completed by the middle of 2015. [More]
Researcher develops novel IBT to help opioid-dependent Vermonters

Researcher develops novel IBT to help opioid-dependent Vermonters

Opioid dependence - addiction to heroin and prescription painkillers - has reached epidemic levels across the country, with treatment waitlists also at an all-time high. [More]
BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy. [More]
Biodelivery Sciences collaborates with Quintiles to launch BUNAVAIL in the U.S.

Biodelivery Sciences collaborates with Quintiles to launch BUNAVAIL in the U.S.

BioDelivery Sciences International, Inc. announced that it has entered into an agreement with Quintiles to provide a range of services to support the anticipated launch of BUNAVAIL (buprenorphine and naloxone buccal film), BDSI's proposed maintenance treatment for opioid dependence. [More]
Orexo signs multi-year agreement with OptumRx and UnitedHealth Group

Orexo signs multi-year agreement with OptumRx and UnitedHealth Group

Orexo AB, the manufacturer of ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII), announced a multi-year agreement with UnitedHealth Group® and OptumRx® providing preferred coverage and reimbursement of ZUBSOLV®. [More]
Study reveals that more than 14% of pregnant women are prescribed opioids for pain

Study reveals that more than 14% of pregnant women are prescribed opioids for pain

More than 14 percent of pregnant women were prescribed opioids (narcotics) for pain at some time during their pregnancy, according to a study posted to the online version of Anesthesiology. [More]
Aetna is helping to reverse abuse of prescription painkillers

Aetna is helping to reverse abuse of prescription painkillers

Abuse of prescription painkillers, known as opioids, is a widespread and growing problem in the United States. The epidemic adds billions of dollars to health care, work place and criminal justice costs each year. [More]
On-site testing for HIV, STIs declines substantially between 2000 and 2011: Study

On-site testing for HIV, STIs declines substantially between 2000 and 2011: Study

A survey of opioid treatment programs finds that the proportion offering on-site testing for human immunodeficiency virus and sexually transmitted infections declined substantially between 2000 and 2011, despite guidelines recommending routine opt-out HIV testing in all health care settings, according to a study appearing in the December 25 issue of JAMA. [More]
RBCC, Therakine reach major milestone in the development of new drug delivery technology

RBCC, Therakine reach major milestone in the development of new drug delivery technology

Rainbow Coral Corp. and its joint venture partner, Therakine, Ltd., are pleased to announce that they have reached a major new milestone in the development of a revolutionary new drug delivery technology. [More]
Opioid dependence causes greatest health burden of all illicit drugs

Opioid dependence causes greatest health burden of all illicit drugs

The first ever analysis of the global and regional prevalence of dependence upon the four major categories of illicit drugs – amphetamine, cannabis, cocaine, and opioids (such as heroin) – has revealed that opioid dependence causes the greatest health burden (overall death and illness) of all the illicit drugs. The results come from new analysis of the Global Burden of Disease Study 2010, and are published in The Lancet. [More]

NSM Insurance Group establishes specialty Behavioral Health, Social Services Unit

NSM Insurance Group announced the establishment of a specialty Behavioral Health, Social Services Unit due to NSM's remarkable growth in this niche over the last 5 years. Bill McKernan, NSM President commented, "It made perfect sense that our Retail clients benefit from the vast expertise NSM has in this space so we created a team comprised of NSM's most experienced Behavioral Health and Social Service Insurance Professionals." [More]

FDA approves Orexo's Zubsolv for people suffering from opioid dependence

Orexo today announced that it has received approval from the U.S. Food and Drug Administration for Zubsolv (buprenorphine/naloxone) sublingual tablet CIII. [More]

Orexo announces dosing of first patient with Zubsolv in phase III clinical study

Orexo AB announces today that the first patient has been dosed with Zubsolv in a phase III study for a new clinical indication for Zubsolv. [More]
BioDelivery Sciences International submits BUNAVAIL NDA to FDA

BioDelivery Sciences International submits BUNAVAIL NDA to FDA

BioDelivery Sciences International, Inc. announced today that it engaged in a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding BUNAVAIL for the maintenance treatment of opioid dependence. [More]
Correctional policies discourage released inmates from seeking methadone therapy, researchers say

Correctional policies discourage released inmates from seeking methadone therapy, researchers say

Methadone treatment for opioid dependence remains widely unavailable behind bars in the United States, and many inmates are forced to discontinue this evidence-based therapy, which lessens painful withdrawal symptoms. [More]