On 7 January, Teva Pharmaceuticals and MedinCell announced positive results from their Phase III trial (RISE Study) evaluating mdc-IRM (risperidone) as a maintenance treatment in adults and adolescents with schizophrenia.

Schizophrenia is a chronic progressive disorder; each relapse increases the burden of disease for patients and carers and has the potential to worsen long-term outcomes. In the RISE Study, participants treated with mdc-IRM saw a statistically significant increase in time to relapse compared to placebo.

Additionally, the safety profile was consistent with the known safety profile of other risperidone formulations. Teva Pharmaceuticals and MedinCell are now looking to the option of a new drug application based on the available clinical data.

Non-compliance is an important factor that can increase the risk of relapse in schizophrenia patients, and is one of the key challenges of treating schizophrenia. In order to try to increase compliance, an increasingly used strategy in the schizophrenia market is long-acting injectable (LAI) drugs, which have a favorable dosing strategy compared to oral therapies.

mdc-IRM is an extended-release injectable suspension for subcutaneous use, which can be administered once monthly or once every two months. In the RISE Study, patients treated with mdc-IRM administered once monthly and once every two months demonstrated a reduction of 80% and 62.5% in the risk to relapse compared to placebo, respectively.

Risperidone is one of the most widely-used antipsychotics for schizophrenia treatment, so if approved mdc-IRM is likely to see good uptake as physicians are highly familiar with risperidone, and it has a competitive edge of being the first risperidone formulation with a once every two months dosing regimen.

However, it will have to directly compete with Indivior’s Perseris (risperidone), an LAI with once-monthly dosing that launched in 2019 in the US and will have first-to-market advantage. GlobalData forecasts Perseris’ global sales to reach $173m in 2026.

As well as the other risperidone formulations, mdc-IRM will also face an increasingly competitive schizophrenia market with LAIs being developed for many of the other antipsychotic drugs used in schizophrenia treatment.

Of note, Janssen’s PP6M (paliperidone palmitate 6-monthly) is awaiting a decision from the European Medicines Agency (EMA), and if approved would be the first LAI schizophrenia treatment with a twice-yearly dosing regimen, giving it a big advantage over the LAIs with shorter dosing regimens, including mdc-IRM. GlobalData forecasts PP6M’s global sales to reach $5.3bn in 2026.

The prevention of venous thromboembolism is one of many priorities in managing Covid-19 patients, but there are several complex considerations, especially when examining preventive strategies for those being managed as outpatients. General considerations include the dose of anticoagulant, anticoagulant drug/drug class choice and treatment duration, as well as when and to whom to administer anticoagulation along the disease spectrum.

According to GlobalData’s Pharma Intelligence Center Clinical Trials Database, as of 23 December, there were only two clinical trials in the US investigating the use of novel oral anticoagulants (NOACs) in Covid-19 outpatients with the goal of preventing thrombosis events. Data readouts from these trials have the potential to affect the anticoagulant landscape. If the results are notable, NOACs will have the opportunity to be integrated into Covid-19 outpatient management strategies.

The two ongoing US trials identified in GlobalData’s database have indicated that NOACs, specifically factor Xa inhibitors, are being investigated in Covid-19 studies.

These include Johnson & Johnson’s PREVENT-HD Phase III trial evaluating whether Xarelto (rivaroxaban) reduces the risk of thrombotic events, all-cause hospitalisation, and all-cause mortality in outpatients with acute Covid-19 infection, and the University of Pittsburg’s Phase III study evaluating Pfizer and BMS’ Eliquis (apixaban) and aspirin (in separate treatment arms) in Covid-19 adults who do not require hospitalisation at time of diagnosis.

According to the National Institutes of Health Covid-19 treatment guidelines, which were updated earlier this month, non-hospitalised Covid-19 patients who are being managed as outpatients should not be treated with prophylactic anticoagulants or antiplatelet therapies. As such, NOAC developers have the opportunity to fill the current void in the Covid-19 space. This sentiment was reiterated by a key opinion leader interviewed by GlobalData.

In addition to the studies mentioned above, a Phase II ongoing trial sponsored by the Bill and Melinda Gates Foundation is evaluating Xarelto in Covid-19 patients with mild disease who are at increased risk of disease progression.

The study is unlike the previous two studies mentioned in that it will specifically involve primary outcome measures looking at adverse events and the proportion of Covid-19 patients with disease progression, as well as secondary outcome measures looking at time to disease resolution and incidence/number of days of hospitalisation.

Collectively, if these studies find that Xarelto is effective in Covid-19 settings, it could obtain a significant edge over fellow NOAC competitors, including Boehringer Ingelheim’s Pradaxa (dabigatran) and Daiichi-Sankyo’s Savaysa (edoxaban).