Waltham, Mass. — Alkermes, Inc. has announced that results from the phase 3 clinical study of Vivitrol (naltrexone for extended-release injectable suspension) in opioid dependence have beenpublished by The Lancet.
The six-month, phase 3 trial met its primary endpoint and showed significantly greater opioid-free weeks among patients treated with Vivitrol, compared to placebo. Vivitrol (which was
recently advocated by CRC Health Group for addiction treatment) is the first and only non-addictive, non-narcotic, once-monthly medication approved by the U.S. Food and Drug Administration (FDA) for the prevention of relapse to opioid dependence, following opioid detoxification. Vivitrol should be used along with psychosocial support such as counseling. In contrast to conventional agonist therapies that maintain stimulation of opioid receptors, Vivitrol is an opioid-blocking antagonist that, when administered once per month, occupies the opioid receptor, thereby helping to prevent patients from relapsing to opioid dependence. "There has been a dramatic increase in the prevalence of opioid dependence, which is a serious, life-threatening disease characterized by high rates of relapse, yet there are so few medications available to treat opioid dependence," stated Evgeny Krupitsky, MD, PhD, Professor of Psychiatry, St. Petersburg State Pavlov Medical University and Head of the Department of Addictions at the Bekhterev Research Psychoneurological Institute.
"The robust data from this phase 3 clinical trial showed that treatment with Vivitrol helped opioid-dependent patients remain drug-free with just one injection per month. Vivitrol is the only once-monthly medication that offers patients and physicians a non-narcotic treatment option to help fight this challenging disease."
The pivotal study also met all secondary endpoints, including opioid craving, self-reported opioid use, study retention rate and incidence of physical opioid dependence. Patients in both the Vivitrol and placebo groups received counseling.
"To date, there has been strong recognition from addiction experts and the treatment community that Vivitrol is an important new treatment option for opioid dependence, and the publication of the phase 3 data is an opportunity for us to more broadly share the comprehensive clinical results demonstrating Vivitrol's safety and efficacy with the addiction treatment community," said Richard Pops, CEO of Alkermes. "Alkermes is committed to advancing the field of addiction treatment through the development of new medications that help patients better manage their disease."
In the phase 3 study, patients treated once-monthly with VIVITROL demonstrated statistically significant higher rates of opioid-free urine tests during the evaluation phase, compared to patients treated with placebo, as measured by the cumulative distribution of opioid-free urine tests (p<0.0002).
Data showed that the median patient taking Vivitrol had 90 percent opioid-free urine tests. A greater percentage of patients in the Vivitrol group remained in the study compared to the placebo group. Safety was assessed through monitoring of treatment-emergent adverse events, vital signs, biochemistry and hematology urine/blood tests including liver function tests, physical examination of injection sites, and baseline and endpoint electrocardiograms. Vivitrol was generally well tolerated in the study; two patients in each treatment arm discontinued due to adverse events. The most common clinical adverse events experienced by patients receiving Vivitrol during the study were hepatic enzyme elevations, nasopharyngitis and insomnia.