FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults.

Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone.

This approval is based on the positive results of the pivotal PRISMA-3 study on the efficacy and safety of Risperidone ISM® in schizophrenia patients. The results obtained in this study show that the two different doses (75 mg and 100 mg once a month) have achieved the prespecified primary and secondary efficacy endpoints for treatment of patients with moderate to severe symptoms of schizophrenia. The primary efficacy endpoint, the PANSS total score (mean difference, CI: 95%), improved significantly with Risperidone ISM® 75 mg and 100 mg from the beginning until day 85, with adjusted differences of -13.0 (17.3 to -8-8; p <0.0001) and -13.3 (-17.6 to -8.9; p<0.0001), respectively, in comparison with the placebo. Significantly improved mean changes for the secondary endpoint, the CGI-S score, were also obtained for Risperidone ISM® in comparison with the placebo, -0.7 (-1.0 to -0.5; p<0.0001), for both doses, from the beginning until day 85. The significant statistical improvement for both efficacy results was observed as early as 8 days after the first injection. The most frequently reported treatment-emergent adverse events were increased blood prolactin (7.8%), headaches (7.3%), hyperprolactinemia (5%) and weight increase (4.8%). No important new or unexpected safety information was reported. Likewise, patients who successfully completed the double-blind period were offered the opportunity to continue in a long-term, open-label 12-month extension phase with once every four weeks injections of Risperidone ISM® (75 mg or 100 mg). New, clinically stable patients ("de novo" patients) were also able to enter this open phase of the study. Long-term treatment was observed to be effective, safe and well tolerated in adult patients with schizophrenia, regardless the initial severity of the disease or whether they had been treated previously with Risperidone ISM® during an acute exacerbation or switched from stable doses of oral risperidone. Likewise, Risperidone ISM® provided a swift and sustained improvement in functioning (both social and personal) and health-related quality of life. These findings, together with a quick onset of effectiveness, could help strengthen the therapeutic alliance and possibly lead to an earlier hospital discharge. Furthermore, the patient’s functioning either continued to improve or remained stable with long-term treatment.

Ref: https://en.wikipedia.org/wiki/Risperidone

FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia

FDA Approves Perseris (risperidone) for Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

In continuation of my update on risperidone

Indivior PLC,   announced that the U.S. Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults. Clinically relevant levels were reached after the first injection of Perseris without use of a loading dose or any supplemental oral risperidone.

"Treatment adherence is a major challenge in schizophrenia due to the complexity of the disease. It is important to have additional treatment options available to physicians to help them improve their patients' symptom severity," said Maurizio Fava, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Indivior clinical research consultant. "The studies carried out by Indivior suggest that Perseris may offer patients, caregivers and physicians a new once-monthly subcutaneous medication option to treat adults with schizophrenia."

Perseris contains risperidone, a well-established treatment for schizophrenia, and uses the extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over one month. Initial peak risperidone plasma levels occur within 4 to 6 hours of dosing and are due to an initial release of the drug during the depot formation process.

"Schizophrenia is a devastating, chronic and often disabling mental health condition that impacts the lives of people suffering from this illness, their families and caregivers. The approval of Perseris brings us the opportunity to provide adult patients and their healthcare providers with an innovative treatment option that we believe will make a meaningful difference," said Shaun Thaxter, Chief Executive Officer of Indivior. "People with schizophrenia face a complex patient journey that can be hindered by ignorance, apathy and stigma. Indivior is committed to working with stakeholders to reduce the stigma of schizophrenia and expand access to evidence-based treatment."

The efficacy of Perseris was evaluated in a pivotal Phase 3 randomized, double-blind, placebo-controlled, 8-week study of 354 patients (NCT 02109562). Perseris efficacy was demonstrated by an improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at day 57. The improvement in Clinical Global Impression Severity of Illness (CGI-S) was also statistically significant at day 57. Clinical trials of Perseris were designed for the product to be initiated with neither a loading dose nor any supplemental risperidone.

The safety of Perseris was evaluated in 814 adults with schizophrenia who received at least one dose of Perseris during clinical trials. A total of 322 patients were treated with Perseris for at least six months, with 234 of those treated with Perseris for at least 12 months. The systemic safety profile of Perseris was consistent with the known safety profile of oral risperidone. The most common systemic adverse reactions in the pivotal Phase 3 trial (in ≥5% of Perseris patients and greater than twice placebo) were increased weight, sedation/somnolence and musculoskeletal pain. The most common injection site reactions (≥5% of all patients across Perseris and placebo groups) were injection site pain and reddening of the skin.

https://www.drugs.com/history/perseris.html

FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

In continuation of my update on Uzedy (risperidone)

Teva Pharmaceuticals,  announced  the U.S. Food and Drug Administration (FDA)  approval of  Uzedy (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq™, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. 

“Uzedy embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva. “The approval of Uzedy is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.”

Approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment,2 most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.3,4

Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts.5 This approval is based on data from two Phase 3 trials evaluating Uzedy in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).

“The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit,” said Christophe Douat, CEO of MedinCell. “We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of Uzedy. Our technology reaching commercial stage marks the start of an exciting new era for MedinCell and we are extremely proud to share this very special moment with all our employees and shareholders.”

The use of novel SteadyTeq technology in Uzedy controls the release of risperidone over time. The initiation of treatment requires no loading dose or oral supplementation. Therapeutic blood concentrations are reached within 6-24 hours of a single dose. 

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia  so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY. “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse1 for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.”

https://pubchem.ncbi.nlm.nih.gov/compound/Risperidone#section=2D-Structure

FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults

Two-drug combo helps adolescents with ADHD, aggression

Prescribing both a stimulant and an antipsychotic drug to children with physical aggression and attention-deficit/hyperactivity disorder (ADHD), along with teaching parents to use behavior management techniques, reduces aggressive and serious behavioral problems in the children, according to a study conducted by researchers at The Ohio State University Wexner Medical Center….

For the "Treatment of Severe Childhood Aggression (TOSCA) Study," 168 children ages 6 to 12 who had been diagnosed with ADHD and displayed significant physical aggression were divided into two groups. All study participants received a psychostimulant drug called OROS methylphenidate (left structure) and their parents received behavioral parent training for nine weeks. The researchers called this treatment combination "basic" because both are evidence-based and have been shown to be helpful for improving both ADHD and aggression.

Researchers wanted to see if they could expand or augment this treatment by adding a second medication. If there was room for improvement at the end of the third week, a placebo was added for the "basic group," while the antipsychotic drug risperidone (right above structure)  was added for participants in the "augmented group."

Compared to the "basic group," the "augmented group" who received the stimulant drug and parent training plus risperidone showed significant improvement (on average with moderately better behavior) on the Nisonger Child Behavior Rating Form (NCBRF) Disruptive-Total Scale, the NCBRF Social Competence subscale and the Reactive Aggression part of the Antisocial Behavior Scale.

While there is always some risk with the addition of a second drug to the treatment package, the two drugs seemed to neutralize some of each other's potential side effects. For instance, children in the augmented group did not seem to have as much trouble falling asleep, once the risperidone was added, Aman said.

"We conducted this study because we viewed the combination of ADHD and significant physical aggression -- especially the aggression -- as a serious situation," Aman said. "It is not uncommon to use more than one medicine for other serious situations, such as when treating cancer or epilepsy for instance. Although doctors have often used stimulants and antipsychotics together in recent years, we did not have good evidence until now that they would work more effectively when carefully staged and given together."

Ref : http://dx.doi.org/10.1016/j.jaac.2013.09.022

Two-drug combo helps adolescents with ADHD, aggression