FDA accepts NDA for subcutaneous risperidone injectable

Teva Pharmaceuticals and MedinCell announced FDA acceptance of a new drug application for risperidone extended-release injectable suspension for subcutaneous use, a schizophrenia treatment.

"The advancements made in managing mental health conditions over the past decade have been shaped by offering patients new treatment options,” Hafrun Fridriksdottir, executive vice president of global research and development at Teva Pharmaceuticals, said in a press release from the two companies. “Now, we are taking the same approach with long-acting treatments, using advanced science to improve disease outcomes for those living with schizophrenia. We’re pleased to share news of this progress as we move one step closer to potentially bringing a new treatment option to patients in need.”

The FDA based its acceptance on data from two phase 3 pivotal studies that assessed the efficacy and long-term safety and tolerability of the schizophrenia treatment TV-46000/mdc-IRM.

In the multicenter, randomized, double-blind, placebo-controlled Risperidone Subcutaneous Extended-Release (RISE) study, researchers evaluated the treatment’s efficacy among 544 patients with schizophrenia aged 13 to 65 years who were randomly assigned to a subcutaneous injection of TV-46000 once per month, once every 2 months or placebo in a 1:1:1 ratio. Time to impending relapse served as the primary endpoint.

In the second study, researchers evaluated the long-term safety, tolerability and effectiveness of subcutaneous administration of TV-46000 once monthly or once every 2 months for up to 56 weeks among 331 patients with schizophrenia aged 13 to 65 years. The frequency of all adverse events, including serious adverse events, served as the primary endpoint. According to the release, the study is ongoing, and interim results have aligned with findings of the RISE study.

"NDA file acceptance marks a major milestone for MedinCell, for our extended-release injectable technology and for patients living with schizophrenia,” Christophe Douat, CEO of MedinCell, said in the joint press release. “Through our strategic collaboration with Teva, we move one step closer towards helping patients and care-providers gain access to our extended-release subcutaneously injectable risperidone.”