Indivior gets boost from expected US regulator's opioid decision
Indivior
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Investors were buying up shares in Indivior anticipating good news from US drug authorities on a new long-lasting opioid addiction treatment a later on Tuesday and results on Thursday.
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The US Food & Drug Administration's advisory committee is meeting on Tuesday to decide whether or not to recommend RBP-6000, Indivior's month-long depot-based injection for the treatment of opioid use disorder.
After a recommendation, or not, on Tuesday a formal FDA decision is expected by 30 November.
After giving RBP-6000 fast-track designation last year, the US drug regulator has worked closely with the company throughout the product's development, with notes showing Indivior "advised to target a plasma buprenorphine level that completely blocked the effects of exogenous opioids at clinically-relevant doses".
Broker Numis noted that Indivior undertook a receptor occupancy study to select the doses for the Phase 2 opioid blockade study, and then designed and completed a single, multi-site placebo controlled trial as per FDA guidance.
With President Donald Trump has tweeting his huge concern about the opioid crisis and set to declare a National Emergency, Numis said the FDA appeared to be concerned by the increasing paediatric exposure to daily buprenorphine treatments and broader misuse, and appears to keen to limit distribution of RBP-6000 to qualified/waived healthcare centres to prevent patients treating themselves.
"This would be in line with our expectations, with the key question not on the approvability per se, but which dose. We detect a slight preference for the lower dose given the higher discontinuation rate, and limited enhancement of efficacy in the higher dose, except in more severe patients."
Expecting approval to be granted, analysts at RBC Capital Markets conducted a survey among 77 US physicians and calculated the product could take a circa-39% patient share quickly and, while prescribing habits would be impacted by a generic film, it sees peak sales of $1.4bn in the US as possible.
Likewise, Citi was also anticipating a positive advisory committee meeting, noting that safety and efficacy of the active ingredient of buprenorphine is already well-established and the Atrigel technology is already approved in Tolmar’s Eligard product.
"The continued focus on the opioid epidemic in the US works in the company’s favour, as does the improved safety and
patient compliance of the depot formulation versus the sublingual film."