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:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and the ... in the world, and the most handsome men, look naturally attractive. Plastic surgery ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered ... Latin America . ... ... ... ...
Breaking Medicine Technology: