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August 26, 2013
Titan Pharmaceuticals reported results of a placebo- and active drug-controlled confirmatory phase II study of Probuphine for the treatment of opioid dependence in 287 adult patients. Probuphine results were statistically significant for the trial’s protocol defined primary endpoint based on the percentages of urine samples that were negative for illicit opioid use, and incorporating patient self-reported opioid use over the 24-week treatment period (p < 0.0001). Patients receiving the Probuphine implant had a higher study completion rate relative to placebo (64& v. 26% (p < 0.0001). Patients receiving the Probuphine implant had lower clinician-rated (p < 0.0001) and patient-rated (p < 0.0001) withdrawal, lower patient-rated (p < 0.0001) craving and better patients’ (p = 0.031) and clinicians’ (p = 0.022) global ratings of improvement. An NDA to the FDA has been submitted.
April 11, 2005
Alkermes reported positive results of a phase III trial of Vivitrex (naltrexone long-acting injection), for the treatment of alcohol dependence. Data met their primary endpoint, producing a significant reduction in the incidence of heavy drinking vs. placebo (p=0.0245). Efficacy was also seen in a number of secondary endpoints in the highest dosing group, including reduction in median number of heavy drinking days per month (3, vs. 19 for placebo), and a reduction of heavy drinking (5 or more drinks per day for men, 4 or more for women) within the first month of treatment. Adverse events were generally mild and decreased over the course of treatment, with injection site reactions occurring most frequently. This multi-center, double-blind, placebo-controlled clinical trial included 624 subjects with a history of alcohol dependence, who were randomized to receive once monthly injections of Vivitrex 380 mg (n=205), Vivitrex 190 mg (n=210), or a placebo (n=209) for 6 months, in addition to low-intensity supportive counseling.
January 13, 2003
DrugAbuse Sciences reported positive results from a phase III trial investigating a sustained release formulation of Naltrexone Depot for the treatment of alcoholism. Results showed that after six months of treatment with the drug subjects were approximately four times less likely to drink heavily and approximately eight times more likely to avoid alcohol altogether than those compared to placebo and psychotherapy. Subjects from 29 treatment sites throughout the U.S. were treated with five sessions of motivational enhancement therapy over the first 12 weeks in the study.