FDA approves long-acting injection for schizophrenia

Key takeaways:

• The FDA approved a long-acting subcutaneous risperidone injection for the treatment of schizophrenia in adults.
• The injection will be available in the United States in the near future.

The FDA approved a long-acting formulation for the treatment of schizophrenia, according to a press release from the manufacturers.

The subcutaneous risperidone injection (Udezy; Teva Pharmaceuticals, MedinCell) comes in a prefilled syringe and elicits therapeutic blood concentrations within 6 to 24 hours of the first dose, according to the release.

The approval is based on positive data from two phase 3 trials, which showed that risperidone reduced the risk for schizophrenia relapse by up to 80% compared with placebo, according to the release.

“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,” Richard Francis, president and CEO of Teva, said in the release.

Udezy helps address adherence challenges, which are the most common reason for schizophrenia relapse, according to Christoph Correll, MD, a professor of psychiatry at Zucker School of Medicine in Hempstead, New York.

“As a clinician, I am excited to now have a new treatment option that reduces the risk [for] relapse for this complex disease and helps address some of the barriers around receiving schizophrenia treatment,” Correll said in the release.

Teva and MedinCell expect to introduce Udezy to the U.S. market within the coming weeks, according to the release.