Pharmaceutical company Indivior PLC (LON:INDV) reported on Monday the launch of the US Food and Drug Administration (FDA) approved PERSERIS (risperidone) first once-monthly for extended-release injectable suspension in the US for the treatment of schizophrenia in adults.

PERSERIS contains risperidone, a well-established medicine for schizophrenia, and uses an extended-release delivery system to form a subcutaneous (under the skin) depot that provides sustained levels of risperidone over one month, added the company.

The US FDA approval of PERSERIS was based on the company's Phase 3 study assessing the efficacy, safety and tolerability of the product in 354 patients aged 18 to 55 years with DSM-IV diagnosis of schizophrenia and an acute episode within eight weeks of screening for the study.

According to the company, PERSERIS efficacy was demonstrated by a statistically significant improvement in the primary clinical endpoint, Positive and Negative Syndrome Scale (PANSS) total score at Day 57. The systemic safety profile of PERSERIS was consistent with the known safety profile of oral risperidone.

In February 2019, the company is anticipating, and preparing for, a full promotional launch by the sales force for PERSERIS and contingent upon the US Court of Appeals upholding the preliminary injunction on generic buprenorphine and naloxone sublingual film against Dr. Reddy's Laboratories.

Additionally, PERSERIS will be distributed in a manner similar to all long-acting injectable antipsychotics and is available now for healthcare professionals to acquire through wholesalers, specialty distributors and pharmacies in an open network approach, concluded the company.