Uzedy partners Teva and MedinCell's latest long-acting schizophrenia candidate notches phase 3 win

After bringing slow-release schizophrenia drug Uzedy to market last year, Teva and France’s MedinCell are using the same playbook for a similar candidate. With a phase 3 win, the duo is on their way to striking gold twice. 

Where Uzedy used MedinCell’s SteadyTeq technology to provide a controlled release of risperidone, which Johnson & Johnson first marketed as Risperdal in the 90s, TEV’749 does the same with olanzapine.

Olanzapine is the most prescribed 2nd generation antipsychotic for schizophrenia in the U.S. Eli Lilly branded the blockbuster med as Zyprexa decades ago and Teva launched its Dr. Reddy’s-partnered generic in 2011.

There’s an open spot on the market for an effective long-acting olanzapine treatment option. The only option of the sort, Lilly’s Zyprexa Relprevv, is linked with a risk of post-injection delirium/sedation syndrome (PDSS). The condition causes the sudden onset of delirium or sedation within hours of receiving treatment.

Teva and MedinCell hope to fill that gap with their once-monthly subcutaneous long-acting injection.

In the phase 3 SOLARIS trial, adult schizophrenia patients in all three dosing groups achieved score changes from baseline on the Positive and Negative Syndrome Scale (PANSS) at week eight. Specifically, the high-, medium- and low-dose group met score differences of -9.71 points, 11.27 points and -9.71 points, respectively.

Key secondary endpoints of total score on both the Clinical Global Impressions – schizophrenia scale and the Personal and Social Performance Scale also met statistical significance, Teva said. No cases of PDSS were reported after injection in any of the studies.

“These encouraging results from the efficacy portion of our Phase 3 SOLARIS trial demonstrate the potential of TEV-‘749 to be an effective long-acting treatment option for schizophrenia and further show our dedication to advancing innovative science in mental health and beyond,” Teva’s chief medical officer and global R&D head Eric Hughes, M.D., Ph.D., said in the company’s release.

The schizophrenia patient population is made up of an estimated 3.5 million people in the U.S. and approximately 1% of the global population, according to Teva.

MedinCell, meanwhile, is “thrilled to be part of this journey with Teva through a strong partnership that allows us to leverage our pioneering long-acting technology for the benefit of patients,” CEO Christophe Douat added.

MedinCell’s BEPO technology, which it licensed to Teva as SteadyTeq, was first commercialized through Uzedy. The tech works by formulating active ingredients so they become a depot after administration, which then breaks down over time and provides a patient with several weeks’ worth of the drug from a single dose.  

The companies will present additional efficacy and safety findings from the study at a medical meeting later this year. An open-label study is currently weighing the long-term safety and incidence of PDSS related to the drug, with a safety data topline readout expected in the second half of this year.