CLINICAL STUDY: Biodegradability of naltrexone‐poly(DL) lactide implants in vivo assessed under ultrasound in humans

Abstract

Ultrasound was used to assess the in vivo biodegradability of a sustained release poly(DL)lactide naltrexone implant in 71 persons previously treated for heroin dependence. We assessed 139 implant sites ranging from 2 to 1808 days post implant. Ultrasound assessment showed that implant tablets were initially well demarcated from each other and from the surrounding tissues. Biodegradation resulted in less demarcated tablets followed by clumping into a single mass-like structure. This mass subsequently dispersed by approximately 1201 days post implant with no implant material visualized by ultrasound. The biodegradation was also assessed by visual clinical examination and palpation of the implant site as well as patient self-report. These measures were generally well correlated with ultrasound results. Clinical assessment of the biodegradation process concluded that the implant changed from 'firm' to 'less firm' and from 'initial square edge' to 'rounded edge' tablets. Collectively, these data provide direct evidence of the in vivo absorption of the Go Medical implant over time, and its biodegradability in humans.

Comparative treatment and mortality correlates and adverse event profile of implant naltrexone and sublingual buprenorphine

“…In some of these patients, reversal of their treatment decision could be revised by relevant manipulations in their social context applicable to workplace, home environment, or social relationships. This relatively benign morbidity profile is consistent with other reports (Hulse et al, 2005;Hulse, Low, et al, 2007;Comer et al, 2006).…”

“…Had this management of severe local wound swelling been better understood earlier in our series, it is likely that at least one of the severe local reactions necessitating implant removal may have been averted. Naltrexone has a mild documented local tissue irritant effect (Hulse et al, 2005;Hulse, Low, et al, 2007) to which some patients appear to have a particular aversion. The other patient with a severe local tissue reaction experienced this problem repeatedly with the implants from one source, but not at all with those from the other.…”

“…Treatment retention, generally assumed to be a central determinant of success with pharmacotherpeutic approaches for addiction, has not been well examined in a NIT cohort. There are few reports of adverse events in NIT (Hamilton et al, 2002;Hulse et al, 2005;Hulse, Low, et al, 2007).…”

Últimos desarrollos en los implantes y las inyecciones depot de naltrexona; el jovencito de la escalera se está haciendo mayor

“…They appear to be generally mild, consistent with the many other studies of implanted polymers, and to resolve steadily over time. 24 A subsequent study 25 using ultrasound rather than histological techniques, came to similar conclusions. After 24 months, very little implant material was seen.…”

A Retrospective Assessment of the Use of Naltrexone Implants for the Treatment of Problematic Amphetamine Use

“…The implant is currently in phase 2/3 of clinical development for the treatment of heroin dependence, with studies thus far demonstrating efficacy, 12 biocompatibility, and biodegradation. 13,14 While the use of oral naltrexone is emerging as a possible treatment option for amphetamine dependence, the use of monthly or longer sustained release naltrexone preparations have yet to be examined. Such preparations would be expected to increase the efficacy of the drug by eliminating noncompliance issues.…”