Navigation Links
Data on Vivitrol for opioid dependence showed sustained efficacy over 18 months
Date:11/9/2011

DUBLIN, Ireland, Nov. 9, 2011 Alkermes plc (NASDAQ: ALKS) today presented positive results from a long-term study of VIVITROL (naltrexone for extended-release injectable suspension) at the 24th Annual U.S. Psychiatric and Mental Health Congress in Las Vegas, NV. Results from the one-year, open-label extension of the six-month pivotal study showed sustained efficacy of VIVITROL, as measured by the number of opioid-free urine screens, in patients who received VIVITROL, in combination with psychosocial treatment, for a total of 18 months of treatment. Additionally, all safety events observed during the open-label extension were consistent with those set forth in the approved product labeling.

"The robust data from this extension study confirm VIVITROL's efficacy and safety profile over an 18-month period and support its clinical utility as a treatment option for opioid dependence, following opioid detoxification," stated Evgeny Krupitsky, M.D., Ph.D., Professor of Psychiatry, St. Petersburg State Pavlov Medical University and Head of the Department of Addictions at the Bekhterev Research Psychoneurological Institute. "VIVITROL is the first and only once-monthly medication that offers patients and physicians a non-narcotic treatment option to help fight this challenging disease."

During the total observation period of 18 months, improvements during the six-month pivotal trial observed in patients treated with VIVITROL were maintained for the duration of the subsequent one-year, open-label extension study. Half of the patients (49%) who entered the one-year extension study, after receiving six months of VIVITROL in the pivotal study, were completely abstinent for the duration of the extension study, based on opioid-free urine screens. The response profile based on the number of opioid-free urine screens was the primary efficacy endpoint of the six-month pivotal study. The extension study also measured opioid craving, improvements in quality of life measures, self-reported opioid use and incidence of physical opioid dependence, confirming the findings documented in the first phase of the study. All patients received psychosocial counseling.

Treatment with VIVITROL during this study showed a low rate of clinical adverse events, the absence of severe adverse events and a low overall rate (2.6%) of injection site pain, with no serious injection site reactions. All safety events observed during the open-label extension were consistent with those set forth in the approved product labeling. No patients discontinued the open-label extension due to serious adverse events. The most common clinical adverse events listed in the extension study were toothache and influenza.

Overall, nearly 65% of patients completed the open-label study, representing a high completion rate for an addiction study. At the onset of the study, 114 patients from the original six-month pivotal trial continued into the open-label, 52-week extension study. Sixty-seven patients continued treatment with VIVITROL, while 47 patients who had been on placebo crossed over to receive VIVITROL.


'/>"/>

Contact: Jennifer Snyder
781-609-6166
Alkermes plc
Source:Eurekalert

Related medicine news :

1. Inadequate access to opioid-based pain relief is a human rights issue for cancer patients
2. PMSI and Ameritox Launch Program to Enhance Quality and Effectiveness of Opioid Therapy
3. Improper use of opioids sparks a new Canadian practice guideline
4. Pre-emptive pain regimen decreased opioid usage in patients undergoing robotic prostatectomy
5. New program targets research on reducing deaths due to prescription opioid overdose
6. Buprenorphine is better than methadone for opioid dependence in pregnant women, study shows
7. Oxycontin, Other Opioid Painkillers Tied to Higher Health Risks
8. Study Finds Third of Cancer Patients on Opioids Are Confused
9. Follow-Up Deemed Lacking for People Taking Opioids
10. Analysis of opioid prescription practices finds areas of concern
11. FDA Looks to Crack Down on Misuse of Opioid Painkillers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Charlotte, NC (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind ... able to be personalized through a fitness app. The fitness app plans to fix the ... solutions currently only offer a one size fits all type program , They ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due to a ... new, often overlooked aspect of head lice: the parasite’s ability to live away from a ... occurrence, but a necessary one in the event that lice have simply gotten out of ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... ... the United States, named Dr. Sesan Ogunleye, as the Medical Director of its new ... the facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. ... from injury. Recently, he has implemented orthobiologic procedures as a method for treating ... one of the first doctors to perform the treatment. Orthobiologics are substances that ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that ... PCT (procalcitonin) assay as a dedicated testing solution for ... clearance, Roche is the first IVD company in the ... risk assessment and management. PCT is a ... in blood can aid clinicians in assessing the risk ...
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... -- The vast majority of dialysis patients currently receive ... usually 3 times a week, with treatment times averaging ... equipment preparation and wait time.  This regimen can be ... who are elderly and frail.  Many elderly dialysis patients ... for some duration of time. Residents in ...
Breaking Medicine Technology: