For the first time in 5 years, the US Food and Drug Administration (FDA) has approved a new treatment for adolescents between the ages of 13 and 17 years who are diagnosed with schizophrenia.
The FDA approved a supplemental new drug application for lurasidone HCI (Latuda; Sunovion Pharmaceuticals), based on results from a 6-week, double-blind, placebo-controlled study. During this trial, adolescent patients were split into 3 groups: those who received 40 mg/day of lurasidone HCI, those who received 80 mg/day of lurasidone HCI, and those receiving a placebo. (Latuda is also approved by the FDA for treatment of adults with schizophrenia, as well as for treatment of adults with major depressive episodes associated with bipolar depression as monotherapy and as adjunctive therapy with lithium or valproate.)
“Approval for the treatment of adolescent schizophrenia has been achieved by only 4 atypical antipsychotic agents prior to lurasidone, with the last approval occurring in 2011,” Antony Loebel, MD, executive vice president and chief medical officer at Sunovion, and head of global clinical development for Sumitomo Dainippon Pharma Group, said in an interview with Psychiatry Advisor.
Dr Loebel also acknowledged several limitations to short-term, placebo-controlled trials. “Although acute treatment findings are useful in understanding longer-term clinical effects, such studies do not provide definitive information on the safety and tolerability of a product when used for more extended periods, or whether a drug is effective in maintenance treatment,” he added. “In addition, patients with a range of medical and other problems, such as alcohol or substance abuse, were excluded from the study, so that the results of treatment in patients with such comorbid conditions may differ from that seen in the clinical trial context.”
Antipsychotic switching should only occur after careful consideration, as well as careful consultation between the patient and either the treating physician or another healthcare provider, Dr Loebel said. “There are likely to be appropriate time points when a new medication can be considered, particularly when the efficacy of current treatment is determined to be inadequate, or there are safety or tolerability concerns that suggest the need for alternative treatment.”
Sunovion’s Latuda® (lurasidone HCl) Receives FDA Approval to Treat Adolescents with Schizophrenia [news release]. Marlborough, MA: Sunovion Pharmaceuticals; January 28, 2017. http://www.businesswire.com/news/home/20170128005011/en/Sunovion%E2%80%99s-Latuda%C2%AE-lurasidone-HCl-Receives-FDA-Approval. Accessed February 15, 2017.