22 September 2020 · Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less…
Jan 20 · Rovi plans to file in the US in H2 2020 .
Jan 20 · Filed in the EU using the centralised procedure for treatment of schizophrenia .
Jul 19 · Rovi announces the conclusion of the PRISMA-31 and BORIS2 studies, thus completing the clinical research program for risperidone ISM®. All data collected and analysed will be included in the registration dossier to apply for marketing authorisation for Doria® for treatment of schizophrenia in the EU & US, in a first phase, and, subsequently, in other countries .
Jul 18 · Rovi plans to file in the US in H2 2019 .
Second generation, intramuscular, sustained release, microparticle formulation of risperidone using a ISM [In Situ Microparticles] drug delivery system. Administered once-monthly.
An English study reported an incidence of 15.2 per 100,000 person-years and a systematic review reported a prevalence of 7.2 per 1,000 persons .
Schizophrenia, acute exacerbations - in situ microimplants
Trial or other data
Dec 18 · PIII PRISMA-3 trial completes .
May 17 · PIII PRISMA-3 trial to evaluate the safety and efficacy of intramuscular injections of extended-release risperidone in patients with acute exacerbations of schizophrenia starts (NCT03160521). Positive and Negative Syndrome Scale (PANSS) total score, assessed at 12 weeks, will be the primary endpoint of this trial. 438 patients will be recruited in the US & Ukraine .
Jul 16 · Results from PRISMA-1 and PRISMA-2 trials and the design of a PIII programme had been reviewed by the US FDA and EMA. The population pharmacokinetic model will be used to predict the steady-state pharmacokinetic exposure of extended release risperidone active moiety after drug administration, and for simulations helping to provide a dosing rationale for the drug .
Mar 15 · PII PRISMA-2 trial that investigated the pharmacokinetics, safety and tolerability of four intramuscular injections of extended-release risperidone (75mg) at 28-day intervals in 70 patients with schizophrenia in the US completes (NCT02086786) .
Perseris · Schizophrenia - once monthly subcutaneous formulation
Development and Regulatory status
Nov 20 · No plans for EU/UK development of Perseris or collaborations with other companies announced .
Nov 20 · Approved for use in Canada (as 90 mg and 120 mg subcutaneous injection) for the treatment of schizophrenia in adults .
Aug 19 · HLS Therapeutics, which has an agreement with Indivior, intends to file a regulatory submission for risperidone sustained-release in Canada by end 2019, & launch in Canada in H2 2020 .
Mar 19 · In its latest annual report, Indivior does not discuss plans for EU development .
Nov 18 · Launched in US .
Jul 18 · Approved by FDA .
Oct 17 · Filed in US based on results of RB-US13-0005 (NCT02203838) study .
Dopamine D2 receptor antagonist and serotonin 2A receptor antagonist in a controlled-release formulation using the ATRIGEL delivery system.
In England there are about 800 per 100,000 people with schizophrenia.
Schizophrenia - once monthly subcutaneous formulation
Trial or other data
Sep 16 · Reckitt Benckiser completes a PIII study that assessed the long-term safety and tolerability of subcutaneously administered risperidone sustained-release formulation in patients with schizophrenia (NCT02203838).
May 15 · Positive Top-Line Results from pivotal PIII multicentre, double-blind, placebo-controlled study (NCT02109562) of RBP-7000 to assess efficacy, safety and tolerability of RBP-7000 in 354 pts experiencing acute exacerbation of Schizophrenia. The trial included adult pts with Schizophrenia and a PANSS total score between 80 and 120 at baseline and hallucinatory behaviour, delusions, conceptual disorganization or suspiciousness. Pts were randomised to receive once-monthly subcutaneous injections 90 mg or 120 mg of RBP-7000 or a matching placebo injection for 8 wks. The primary efficacy endpoint of the study was the mean change from baseline at Week 8 in PANSS total score; scores were -9.2 points for placebo; -15.4 points for RBP-7000, 90 mg, p=0.0004 vs. placebo; and -16.4 points for RBP-7000, 120 mg, p<0.0001 vs. placebo. Pre-specified key secondary endpoint of improvement on the Clinical Global Impression-Severity of Illness (CGI-S) scale were also met; for each RBP-7000 group vs. placebo at Week 8 (p=0.0002 vs. placebo for RBP-7000, 90 mg; and p<0.0001 vs. placebo for RBP-7000, 120 mg). RBP-7000 was generally well tolerated in the study, and the observed safety profile of RBP-7000 was similar to that reported with oral risperidone .