16th Apr 2020 12:18
(Alliance News) - Indivior PLC on Thursday announced it has published long-term safety data for its Sublocade injection, showing a safety profile consistent with transmucosal buprenorphine.
Shares in Indivior were up 6.1% at 49.18 pence in London at midday.
Opiate replacement buprenorphine is the active ingredient in Sublocade, which is intended to treat opioid use disorder.
Sublocade is a slow-release injectable form of buprenorphine, differing from Indivior's other addition product Suboxone sublingual film - a transmucosal form of buprenorphine which is dissolved in the mouth rather than injected.
The study - entitled "Treating Opioid Use Disorder with a Monthly Subcutaneous Buprenorphine Depot Injection: 12-month Safety, Tolerability and Efficacy Analysis" - has been published online and will appear in an upcoming print issue of the Journal of Clinical Psychopharmacology.
It was an open-label study in adults with moderate or severe opioid use disorder. A total of 257 participants from a previous Sublocade trial and 412 participants who had not been treated with Sublocade were enrolled in the trial. In total, 61% of participants completed the study and received as many as 12 injections.
At 12 months, the safety profile of Sublocade was found to be consistent with transmucosal buprenorphine - excepting injection-site reactions. These reactions had been anticipated, Indivior said.
A total of 67% of participants reported more than one treatment-emergent adverse event, with 13% of participants reporting injection-site events. These injection-site events were largely "mild or moderate in severity". The incidence of these events was lower in the second six months of treatment compared to the first six months, the company said.
No unexpected safety signals were detected in the trial, and there were no treatment-emergent adverse events relating to respiratory depression.
The liver safety profile of the Sublocade was comparable to transmucosal buprenorphine and longer exposure to the highest maintenance dose, 300 milligrams, did not worse hepatic laboratory assessments. No liver cell injury was indicated and no Sublocade removal was needed.
At 12 months of treatment, 62% of previous trial participants and 76% of new participants were found to be "free of illicit opioid use".
Indivior Chief Scientific Officer Christian Heidbreder said: "Recent research has shown that treatment is most helpful when it addresses opioid use disorder as a chronic disease that requires services and support structures over an extended period of time.
"Data from this open-label study provide additional scientific evidence in support of the long-term safety profile of Sublocade and may help clinicians to determine how best they can help patients achieve and maintain recovery."
By Anna Farley; [email protected]
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