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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

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

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. [More]
BioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN treatment

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). [More]
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 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]
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