Clinical Trials Resource Center

New Medical Therapies™

Substance Abuse

Patient Medical Areas

April 14, 2014

Collegium Pharmaceutical reported results of a phase II study evaluating the effect of physical manipulation by crushing Oxycodone DETERx compared with reformulated Oxy- Contin. The objective was to assess pharmacokinetics of Oxycodone DETERx when the capsule was taken intact after oral administration compared with opening the capsule and crushing the capsule contents (microspheres) prior to oral administration. These treatments were compared with OxyContin intact, OxyContin crushed and an immediate-release (IR) oxycodone tablet formulation crushed in naltrexone-blocked, healthy subjects (n=42). The study was an open label, randomized, active-controlled, five-treatment, five-period, cross-over comparison design. Crushed Oxycodone DETERx capsule contents (microspheres) (Cmax = 62.9ng/mL) were bioequivalent based upon Cmax and AUC to intact Oxycodone DETERx capsules) (Cmax = 67.5ng/mL) with similar Tmax demonstrating that crushing the contents of Oxycodone DETERx capsules did not alter the pharmacokinetics. Crushed OxyContin tablets (Cmax = 78.4ng/mL) were bioequivalent based upon Cmax and AUC to crushed IR tablets (Cmax = 79.4ng/mL), demonstrating that crushing OxyContin compromised the integrity of the time-release formulation, transforming the drug-release profile from an ER profile to an IR profile. The mean Abuse Quotient (“AQ” = Cmax/Tmax) value for crushed Oxycodone DETERx was lower than that of Oxycodone DETERx intact. The AQ for crushed OxyContin was approximately four times higher than the AQ value for OxyContin intact and similar to the crushed oxycodone IR tablets. The product’s abuse-deterrent characteristics are being evaluated in phase III trials, which have completed enrollment. The company is on track to file an NDA in Q4 of this year.

January 27, 2014

Collegium Pharmaceutical has released results of a phase II trial of Oxycodone DETERx, an abuse-deterrent, oxycodone microspherein- capsule product. The randomized, doubleblind, double-dummy, positive- and placebocontrolled, single-dose, four-treatment, four-period crossover comparison study was designed to evaluate the abuse potential and pharmacokinetics of crushed 40mg Oxycodone DETERx intranasal, intact 40mg of Oxycodone DETERx oral and crushed 40mg of IR oxycodone intranasal. The study enrolled 36 non-dependent, recreational opioid users. The primary endpoint for the study was drug liking, measured up to 24 hours after dosing, using a bipolar visual analogue scale (VAS). Oxycodone DETERx (both crushed intranasal and intact oral) had significantly lower peak “drug liking” (Emax) when compared with intranasal crushed IR oxycodone (p<0.0001). Furthermore, when comparing Oxycodone DETERx treatments, Emax for “drug liking” after administration of crushed intranasal Oxycodone DETERx was significantly lower than for intact oral administration of DETERx (p<0.05). The secondary measure of “bad drug effects” was numerically highest for intranasal crushed Oxycodone DETERx. A phase III trial currently is enrolling.

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.

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