Indivior upbeat on publication of Sublocade data
By Josh White
Date: Tuesday 19 Feb 2019
(Sharecast News) - Indivior shared data from its phase-three clinical trial evaluating the efficacy, safety and tolerability of its new 'Sublocade' buprenorphine extended-release injectable treatment for opioid addiction, which were published by peer-reviewed medical journal The Lancet.
The FTSE 250 specialty pharmaceutical company said the 24-week trial met its primary and key secondary endpoints for both the 300/300 mg and 300/100 mg dosage regimens of Sublocade, which demonstrated "clinically and statistically significant" differences in percentage abstinence from opioid use based on negative urine samples and self-reports of illicit drug use, as well as treatment success defined as participants with more-than-80% opioid abstinence during weeks five to 24, compared to placebo.
"Findings show that Sublocade administered by healthcare providers delivered sustained buprenorphine exposure for the entire monthly period while increasing abstinence rates and controlling craving and withdrawal symptoms for patients in this pivotal trial, compared to placebo," said Indivior's chief scientific officer Christian Heidbreder.
"This represents an effective option in the treatment of opioid use disorder. We are proud of the potential impact that these data represent for patients on their path to recovery from opioid use disorder and our continuing efforts to partner with the treatment community."
Indivior said the manuscript, published on 18 February in The Lancet, was titled 'Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.'
It said the phase 3 study served as one of the key studies from the clinical development programme that supported the US Food and Drug Administration (FDA) approval of Sublocade in November 2017.
Walter Ling, professor emeritus of psychiatry and founding director of the Integrated Substance Abuse Programs (ISAP) at the University of California, Los Angeles, said: "These data show Sublocade can be effective in maintaining control of some barriers, making it an important treatment option for patients with moderate to severe opioid use disorder."
In the phase 3 trial, Indivior said a total of 504 treatment-seeking adults with moderate or severe opioid use disorder were randomised to monthly Sublocade 300/300 mg - six 300 mg injections; Sublocade 300/100 mg - two 300 mg injections and four 100 mg injections; or placebo - six placebo injections - for 24 weeks and received weekly individual drug counselling.
No supplemental buprenorphine was allowed.
Withdrawal and craving symptoms were partially clinically controlled with buprenorphine/naloxone sublingual film prior to the first injection of Sublocade, Indivior confirmed.
The primary efficacy endpoint was percentage abstinence from opioid use, based on negative urine samples and self-reports of illicit drug use at weeks five to 24, with a secondary efficacy endpoint where participants showed more than 80% opioid abstinence during weeks five to 24. Other secondary efficacy endpoints included opioid craving and withdrawal.
The company said the results showed that Sublocade met the primary efficacy endpoint, with both dosage regimens demonstrating mean percentage abstinence rates "significantly higher" than those of the placebo group.
Both Sublocade dosage regimens also met the key secondary endpoint for treatment success.
In addition, mean withdrawal and craving scores in both Sublocade groups remained "relatively constant", and were consistently lower than those observed in the placebo group.
"This is the first published study to translate the original observations which suggested that more than 70%-80% brain mu-opioid receptor occupancy associated with buprenorphine plasma concentrations of at least 2-3 ng/mL is required to block subjective drug-liking of exogenous opioid, into statistically significant clinical efficacy," the Indivior board said in its statement.
Shares in the company were down more than 7% to 109.5p.
In light of recent court developments making the launch of generic rivals to Indivior's Suboxone sublingual film appear more likely, analysts at Jefferies said the focus is now "solely on the launches of Sublocade, and to a lesser extent, Perseris", a new treatment for schizophrenia.
"We expect the ramp in these won't be enough to return to profitability in the next two years, although this depends on capacity for further cost cutting," the analysts said, calculating that the current near-$700m net cash is "enough to sustain the business over this period" despite its estimate of $300m outflow in 2019.
The analysts forecast the launches of generic rivals would lead to sales more than halving in 2019 to $459m, leading to operating loses of circa $60m, with little improvement in 2020 as "further erosion of film sales should mostly offset growth in Sublocade and Perseris".
Email this article to a friend
or share it with one of these popular networks:
You are here: news
10 Lower Thames St,
London EC3R 6EN