SCYNAPSIS
#neurosciences
#neurosciences
#neurosciences
Image credit by Laboratorios ROVI
Image credit by Laboratorios ROVI
Image credit by Laboratorios ROVI
Pablo Avalos Prado
Pablo Avalos Prado
Pablo Avalos Prado
Neuroscientist & Medical Writer
Neuroscientist & Medical Writer
Neuroscientist & Medical Writer
July 28, 2023
July 28, 2023
July 28, 2023
FDA grants approval for Okedi, a long-acting injectable antipsychotic for schizophrenia
FDA grants approval for Okedi, a long-acting injectable antipsychotic for schizophrenia
FDA grants approval for Okedi, a long-acting injectable antipsychotic for schizophrenia
ROVI’s drug Okedi is a monthly injectable treatment for schizophrenia whose novel ISM technology allows prolonged release of risperidone and fast clinical outcomes.
Yesterday, the US Food and Drug Administration (FDA) approved Okedi, the brand name for the long-acting injectable (LAI) risperidone developed by the Spanish pharmaceutical company ROVI. After the European Commission thumbed-up Okedi’s distribution in Europe in February 2022, the Spanish company was expecting FDA’s positive evaluation of its manufacturing plant of injectables, one last box to check before its approval by the American organization. With FDA’s green light, Okedi, which is currently marketed in European countries like Germany, Spain, Portugal and the UK, will be also available for patients with schizophrenia in the US.
A new long-term treatment for schizophrenia that shows fast and maintained results
Both the European Commission's and FDA’s positive decision was motivated by the promising results shown by this antipsychotic in the different clinical studies evaluating its safety, tolerability and clinical efficacy. According to these results, following intramuscular injection of the product in adults, risperidone levels in blood reaches a first peak between the first and second day after the injection and a second peak by the third week, with therapeutic levels of risperidone maintained for over one month.
The phase-III clinical trial (PRISMA-III) and the following open-label extension study (OLE) revealed that this formulation of risperidone was also safe and well-tolerated in adults. The randomized and double-blind PRISMA-III trial demonstrated that patients with schizophrenia showed reduced symptoms already one week after the injection, as evidenced by different behavioral tests used to evaluate the severity of the disease. Additionally, the results indicated that more than half of patients had a reduction of at least 30 % of symptoms one month after the injection, which reflects the long-term effect and the little variability of this treatment. Another promising outcome of this study is the great clinical reduction observed in the symptomatology scores between individuals who received placebo and those who had the actual drug, which was higher than in other trials using similar LAIs antipsychotics.
In the complementing OLE study, which involved placebo and risperidone patients from the PRISMA-III study and new patients with schizophrenia, all individuals received a monthly injection of Okedi for one year. The results showed an improvement of symptoms in all groups from the first injection to the end of the treatment, which was particularly high in those who received placebo in the previous study.
ISM technology allows prolonged release of risperidone and improved adherence
Risperidone, the active ingredient of Okedi, is a second generation antipsychotic for treating schizophrenia. As such, risperidone targets dopaminergic receptors in brain areas like the limbic and associative striatum, which are linked to reward-related behaviors and decision-making and which show aberrant function in patients with schizophrenia. This explains the beneficial effects of risperidone on the so-called “positive symptoms” of schizophrenia, which include paranoia and hallucinations. However, Okedi was also effective against other symptoms.
Although it is considered a first-line therapy for this disease, risperidone is often delivered as an oral treatment which is associated with poor adherence by patients who lack insight into their need for medication and end-up by interrupting their therapy. Since adherence tends to decrease with increasing duration of treatment, especially in patients with chronic schizophrenia, new LAIs are emerging to overcome this problem.
The new risperidone formulation developed by ROVI lies on an alternative injectable long-acting delivery of this antipsychotic using an “in-situ microimplants” (ISM) technology patented by the same company. This technology is based on a stable and solid polymer containing risperidone. The polymers are reconstituted into a solvent that, once injected, leads to the formation of implants that erode slowly, providing a sustained and controlled release of the drug for up to 1 month. Because of its improved stability and the reduced number of necessary doses, the same ISM technology has been applied to other treatments for different diseases, with good results in breast cancer therapy.
The approval granted by the FDA, together with the recent announcement by ROVI of the development of a new risperidone formulation injectable every three months instead of one month, is a promising step toward improving the quality of life for individuals living with this challenging condition.
Sources
ROVI’s drug Okedi is a monthly injectable treatment for schizophrenia whose novel ISM technology allows prolonged release of risperidone and fast clinical outcomes.
Yesterday, the US Food and Drug Administration (FDA) approved Okedi, the brand name for the long-acting injectable (LAI) risperidone developed by the Spanish pharmaceutical company ROVI. After the European Commission thumbed-up Okedi’s distribution in Europe in February 2022, the Spanish company was expecting FDA’s positive evaluation of its manufacturing plant of injectables, one last box to check before its approval by the American organization. With FDA’s green light, Okedi, which is currently marketed in European countries like Germany, Spain, Portugal and the UK, will be also available for patients with schizophrenia in the US.
A new long-term treatment for schizophrenia that shows fast and maintained results
Both the European Commission's and FDA’s positive decision was motivated by the promising results shown by this antipsychotic in the different clinical studies evaluating its safety, tolerability and clinical efficacy. According to these results, following intramuscular injection of the product in adults, risperidone levels in blood reaches a first peak between the first and second day after the injection and a second peak by the third week, with therapeutic levels of risperidone maintained for over one month.
The phase-III clinical trial (PRISMA-III) and the following open-label extension study (OLE) revealed that this formulation of risperidone was also safe and well-tolerated in adults. The randomized and double-blind PRISMA-III trial demonstrated that patients with schizophrenia showed reduced symptoms already one week after the injection, as evidenced by different behavioral tests used to evaluate the severity of the disease. Additionally, the results indicated that more than half of patients had a reduction of at least 30 % of symptoms one month after the injection, which reflects the long-term effect and the little variability of this treatment. Another promising outcome of this study is the great clinical reduction observed in the symptomatology scores between individuals who received placebo and those who had the actual drug, which was higher than in other trials using similar LAIs antipsychotics.
In the complementing OLE study, which involved placebo and risperidone patients from the PRISMA-III study and new patients with schizophrenia, all individuals received a monthly injection of Okedi for one year. The results showed an improvement of symptoms in all groups from the first injection to the end of the treatment, which was particularly high in those who received placebo in the previous study.
ISM technology allows prolonged release of risperidone and improved adherence
Risperidone, the active ingredient of Okedi, is a second generation antipsychotic for treating schizophrenia. As such, risperidone targets dopaminergic receptors in brain areas like the limbic and associative striatum, which are linked to reward-related behaviors and decision-making and which show aberrant function in patients with schizophrenia. This explains the beneficial effects of risperidone on the so-called “positive symptoms” of schizophrenia, which include paranoia and hallucinations. However, Okedi was also effective against other symptoms.
Although it is considered a first-line therapy for this disease, risperidone is often delivered as an oral treatment which is associated with poor adherence by patients who lack insight into their need for medication and end-up by interrupting their therapy. Since adherence tends to decrease with increasing duration of treatment, especially in patients with chronic schizophrenia, new LAIs are emerging to overcome this problem.
The new risperidone formulation developed by ROVI lies on an alternative injectable long-acting delivery of this antipsychotic using an “in-situ microimplants” (ISM) technology patented by the same company. This technology is based on a stable and solid polymer containing risperidone. The polymers are reconstituted into a solvent that, once injected, leads to the formation of implants that erode slowly, providing a sustained and controlled release of the drug for up to 1 month. Because of its improved stability and the reduced number of necessary doses, the same ISM technology has been applied to other treatments for different diseases, with good results in breast cancer therapy.
The approval granted by the FDA, together with the recent announcement by ROVI of the development of a new risperidone formulation injectable every three months instead of one month, is a promising step toward improving the quality of life for individuals living with this challenging condition.
Sources
ROVI’s drug Okedi is a monthly injectable treatment for schizophrenia whose novel ISM technology allows prolonged release of risperidone and fast clinical outcomes.
Yesterday, the US Food and Drug Administration (FDA) approved Okedi, the brand name for the long-acting injectable (LAI) risperidone developed by the Spanish pharmaceutical company ROVI. After the European Commission thumbed-up Okedi’s distribution in Europe in February 2022, the Spanish company was expecting FDA’s positive evaluation of its manufacturing plant of injectables, one last box to check before its approval by the American organization. With FDA’s green light, Okedi, which is currently marketed in European countries like Germany, Spain, Portugal and the UK, will be also available for patients with schizophrenia in the US.
A new long-term treatment for schizophrenia that shows fast and maintained results
Both the European Commission's and FDA’s positive decision was motivated by the promising results shown by this antipsychotic in the different clinical studies evaluating its safety, tolerability and clinical efficacy. According to these results, following intramuscular injection of the product in adults, risperidone levels in blood reaches a first peak between the first and second day after the injection and a second peak by the third week, with therapeutic levels of risperidone maintained for over one month.
The phase-III clinical trial (PRISMA-III) and the following open-label extension study (OLE) revealed that this formulation of risperidone was also safe and well-tolerated in adults. The randomized and double-blind PRISMA-III trial demonstrated that patients with schizophrenia showed reduced symptoms already one week after the injection, as evidenced by different behavioral tests used to evaluate the severity of the disease. Additionally, the results indicated that more than half of patients had a reduction of at least 30 % of symptoms one month after the injection, which reflects the long-term effect and the little variability of this treatment. Another promising outcome of this study is the great clinical reduction observed in the symptomatology scores between individuals who received placebo and those who had the actual drug, which was higher than in other trials using similar LAIs antipsychotics.
In the complementing OLE study, which involved placebo and risperidone patients from the PRISMA-III study and new patients with schizophrenia, all individuals received a monthly injection of Okedi for one year. The results showed an improvement of symptoms in all groups from the first injection to the end of the treatment, which was particularly high in those who received placebo in the previous study.
ISM technology allows prolonged release of risperidone and improved adherence
Risperidone, the active ingredient of Okedi, is a second generation antipsychotic for treating schizophrenia. As such, risperidone targets dopaminergic receptors in brain areas like the limbic and associative striatum, which are linked to reward-related behaviors and decision-making and which show aberrant function in patients with schizophrenia. This explains the beneficial effects of risperidone on the so-called “positive symptoms” of schizophrenia, which include paranoia and hallucinations. However, Okedi was also effective against other symptoms.
Although it is considered a first-line therapy for this disease, risperidone is often delivered as an oral treatment which is associated with poor adherence by patients who lack insight into their need for medication and end-up by interrupting their therapy. Since adherence tends to decrease with increasing duration of treatment, especially in patients with chronic schizophrenia, new LAIs are emerging to overcome this problem.
The new risperidone formulation developed by ROVI lies on an alternative injectable long-acting delivery of this antipsychotic using an “in-situ microimplants” (ISM) technology patented by the same company. This technology is based on a stable and solid polymer containing risperidone. The polymers are reconstituted into a solvent that, once injected, leads to the formation of implants that erode slowly, providing a sustained and controlled release of the drug for up to 1 month. Because of its improved stability and the reduced number of necessary doses, the same ISM technology has been applied to other treatments for different diseases, with good results in breast cancer therapy.
The approval granted by the FDA, together with the recent announcement by ROVI of the development of a new risperidone formulation injectable every three months instead of one month, is a promising step toward improving the quality of life for individuals living with this challenging condition.
Sources