These young patients range in age from 10-17 years old.
In 2009, the FDA had previously approved Saphris® for the treatment of schizophrenia and bipolar I disorder in those over the age of 18.
Saphris® is an atypical antipsychotic. The term atypical refers to the reduced incidence of movement disorders that other first generation anti-psychotics more commonly cause.
Bipolar I disorder, also known as manic depressive illness, is a form of mental illness. The illness can develop at different times but often begins in the pediatric age group.
The exact cause is unknown but scientists believe genes, brain function and anxiety disorders attribute to its development.
Children who develop this illness are considered to have early-onset bipolar disorder. This type can be more severe than bipolar disorder in older teens and adults.
During a three-week clinical trial conducted by Merck Sharp & Dohme Corp., 403 children ages 10-17, who displayed manic or mixed episodes in association with bipolar I disorder, were monitored. Of this group, 302 children were given 2.5 mg, 5 mg or 10 mg doses twice daily, while the remainder received a placebo.
The children who were given the medication all showed signs of improvement with overall severity of symptoms as well as improvements in mania, leading the FDA to approve Actavis' supplemental new drug application for SAPHRIS® (asenapine) for treatment of pediatric patients .
Side effects were noted within the participants. They included: fatigue, vertigo, mouth numbness, nausea, increased appetite, weight gain, and strange tastes in the mouth.
Bipolar disorders can cause different types of mood episodes which can last anywhere from a few days to a few months when left untreated. A child may have manic episodes, depressive episodes or "mixed" episodes
A manic episode includes an elevated mood or feeling of euphoria.
According to the National Institute of Mental Health, children who experience manic episodes can have a short temper, increased rate of speech, jump topics, and have trouble focusing or sleeping. They may think about sexual acts or partake in risky behavior.
During a depressive episode the opposite occurs and the child’s mood swings to a darker side.
The NIMH says a child who experiences a depressive episode may complain about pain, feel sad, or have unusual sleep and eating patterns. The child may have no interest in enjoyable activities, or may have suicidal thoughts.
The third type of episode is a mixed episode, which can include some combination of both. Mood episodes can be intense with extreme changes in behavior and energy levels.
There is no cure for bipolar disorder. Doctors treat children using the same therapies as treating adults. Treatment can help control symptoms. Treatment works best when it is ongoing, instead of on and off.
Saphris will be available to pediatric patients who suffer bipolar I disorder in the second quarter of 2015.
National Institute of Mental Health. Bipolar Disorder in Children and Teens. Retrieved March 16,2015.
WebMD. Bipolar I Disorder. Retrieved March 16, 2015.
Psychiatric News. FDA Approves Antipsychotic for Treatment of Pediatric Bipolar Disorder. Retrieved March 16, 2015.
Saphris. Retrieved March 16,2015.
Reviewed March 17, 2015
by Michele Blacksberg RN
Edited by Jody Smith