Indivior (LON:INDV) has impressed with its first notable news since it spun out of Reckitt Benckiser (LON:RB) late last year. The specialty pharma company reported that its schizophrenia drug RBP-7000 met the primary endpoint in a Phase III trial, moving it a step closer to its goal of winning FDA approval in 2017.
|Indivior CEO Shaun Thaxter|
Slough, U.K.-based Indivior gave 354 people with acute exacerbation of schizophrenia monthly injections of one of two doses of RBP-7000 or a placebo. After 8 weeks, patients in both treatment arms experienced statistically significant improvements in their Positive and Negative Syndrome Scale (PANSS) scores over their baseline figures. PANSS scores in patients who received the higher of the two doses fell 16.4 points, compared to a decline of 9.2 points in the placebo arm.
Both treatment arms also met the secondary endpoint of improvements on the Clinical Global Impression-Severity of Illness (CGI-S) scale over placebo. The safety profile of RBP-7000 in the trial was comparable to that of oral risperidone, the now-generic antipsychotic originally sold by Johnson & Johnson ($JNJ) as Risperdal. Indivior is now running an open-label extension to the trial, in which it will administer 11 more injections to participants who meet some additional inclusion/exclusion criteria to gather long-term safety and tolerability data.
The long-term data will feed into a planned new drug application with FDA. Indivior is aiming to win approval for RBP-7000 in the U.S. in 2017. The positive data and their implications contributed to a 9% rise in the share price of Indivior, a significant increase for a company with a market capitalization of around £3 billion ($4.5 billion). Indivior spun out of consumer goods giant Reckitt Benckiser last year and has a clutch of drugs in Phase III. As well as RBP-7000, Indivior is also moving opioid dependence and overdose treatments toward regulatory filings.
- read the release