ROVI receives FDA approval for Risvan® to treat schizophrenia
02.04.2024 17:18
Laboratorios Farmacéuticos Rovi, SA announced on April 2 that the U.S. Food and Drug Administration (FDA) has approved the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.
Risperidone ISM® is an injectable depot antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults where the tolerability and efficacy of oral risperidone have been demonstrated. The innovative formulation achieves plasma levels in the therapeutic range quickly and sustainably after the first injection, without the need for oral supplementation or loading dose. [1]
The approval is based on the positive results of the Phase 3 PRISMA-3 clinical trial on the efficacy and safety of Risperidone ISM® in patients with schizophrenia. [2] Both available doses (75 mg and 100 mg every 28 days) met the pre-specified primary and secondary efficacy endpoints for the treatment of patients with moderate to severe symptoms of schizophrenia. The primary efficacy endpoint, the PANSS† total score, improved significantly with Risperidone ISM® 75 mg and 100 mg from baseline to day 85, with adjusted differences of -13.0 (95%-CI -17.3 to -8.8; p <0.0001) and -13.3 (95%-CI -17.6 to -8.9; p<0.0001), respectively, compared to placebo. Significantly improved mean changes for the secondary endpoint, the CGI-S‡ score, were also achieved for Risperidone ISM® compared to placebo: -0.7 (95% CI -1.0 to -0.5; p<0.0001) for both doses from baseline to day 85. A statistically significant improvement for both efficacy outcomes was observed with the 100 mg dose as early as 8 days after the first injection and with the 75 mg dose this was achieved on day 15. The most commonly reported treatment-emergent adverse events were increased blood prolactin (7.8%, 7.3%, 7.3%, 7.4%, 7.6%, 7.8%, 7.9%, 8.2%, 8.8 ...
Patients who successfully completed the double-blind phase were offered the opportunity to participate in an open-label 12-month extension study3, during which they could continue to use Risperidone ISM® (75 mg or 100 mg every 4 weeks). New, clinically stable patients (“de novo” patients) could also participate in this open-label phase of the study. Long-term treatment was shown to be effective, safe and well tolerated in adult patients with schizophrenia, regardless of the initial severity of the illness or whether they had previously been treated with Risperidone ISM® during an acute exacerbation or were switching from established treatment with oral risperidone. [3]
In addition, Risperidone ISM® led to a rapid and sustained improvement in (social and personal) functioning and health-related quality of life. [4] Maintenance or continuous improvement in patients' functioning was also observed during long-term treatment. [4] These results and the rapid onset of action could help to strengthen the therapeutic alliance between patients and therapists and promote earlier discharge from hospital.
“We are very pleased with the FDA approval of Risvan® because we believe our drug can contribute to the clinical treatment of schizophrenia patients and improve treatment adherence,” commented Juan López-Belmonte Encina, Chairman and Chief Executive Officer of ROVI.
About ISM® Technology
ISM® is a ROVI-patented drug delivery technology platform based on the in situ formation of biodegradable matrices following administration of a liquid carrier. Thanks to their unique properties, therapeutic drug concentrations can be achieved quickly after administration without the need for oral
Concomitant medication, additional boosters or loading injections are required to achieve and maintain concentrations in a predictable and sustainable manner.
Sources
1. Walling DP, Hassman HA, Anta L et al. The steady-state comparative bioavailability of intramuscular risperidone ISM and oral risperidone: an open-label, one-sequence study. Drug Des Devel Ther. 2021 Oct 15;15:4371-4382.
2. Correll, CU, Litman, RE, Filts, Y. et al. Efficacy and safety of once-monthly Risperidone ISM® in schizophrenic patients with an acute exacerbation. npj Schizophr 6, 37 (2020). https://doi.org/10.1038/s41537-020-00127-y
3. Filts Y, Litman RE, Martínez J, Anta L, Naber D, Correll CU. Long-term efficacy and safety of once-monthly risperidone ISM® in the treatment of schizophrenia: results of a 12-month open-label extension study. Schizophr Res. 2021 Nov 27;239:83-91.
4. Litman R, Naber D, Anta L, Martínez J, Filts Y, Correll CU. Personal and social functioning and health-related quality of life in patients with schizophrenia treated with the long-acting injectable antipsychotic risperidone ISM. Neuropsychiatr Dis Treat. 2023 Jan 25;19:219-232.