7th Mar 2019 15:12
LONDON (Alliance News) - Indivior PLC on Thursday said the patient-centred outcome endpoints from its phase three trial of Sublocade in opioid use disorder have been published.
The results were published in the Journal of Addiction Medicine, and were based on a 24-week randomised trial that used a placebo control. This study was key to the approval of Sublocade in the US.
Patient-centred outcome endpoints included physical and mental health, satisfaction with the medication, employment, and health insurance status.
Results from the trial showed that patients taking Sublocade, a slow-release injectable form of the opiate replacement buprenorphine, were more satisfied with their treatment than those taking a placebo - 88% with Sublocade versus 46% without. Moreover, employment was 11% higher in the group taking Sublocade and patients taking the drug had fewer hospital days.
"Our results show, for the first time, that compared with placebo, six monthly injections of Sublocade improved health status and health-related quality of life. Increased medication satisfaction, increased employment, and decreased healthcare utilization were also observed." said Indivior Chief Scientific Officer Christian Heidbreder.
"We believe that these improvements will contribute to facilitate access, adherence, and retention to treatment, which will further encourage patients to continue along their pathway towards recovery," Heidbreder added.
Shares in Indivior were up 4.1% at 116.55 pence each on Thursday.
In February, Indivior launched an authorised generic version of its other opiate addiction product, Suboxone sublingual film, in the US. Suboxone is another form of buprenorphine, but it is dissolved in the mouth rather than injected.
The Suboxone generic is Indivior's response to the expected launch of a generic sublingual film product by Dr Reddy's Laboratories and Alvogen Pine Brook LLC in the US. Indivior has been fighting with Dr Reddy's to prevent the rival generic launch but has not been successful.
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