Med Check

FDA Approves Aristada for Treatment of Schizophrenia

Last month, the Food and Drug Administration approved Aristada (aripiprazole lauroxil), a long-acting injectable antipsychotic, for the treatment of schizophrenia. The medication requires administration by a health care professional every four to six weeks.

The approval of Aristada was based, in part, on the results of a 12-week clinical trial of 623 participants with schizophrenia who were experiencing an acute exacerbation. Participants were randomly assigned to receive a gluteal intramuscular injection of aripiprazole lauroxil (441 mg or 882 mg) or matching placebo once monthly for 12 weeks.

Patients in the 441 mg and 882 mg aripiprazole lauroxil groups demonstrated greater improvements in total scores on the Positive and Negative Syndrome Scale and the Clinical Global Impressions-Improvement scale than those treated with placebo. The most common side effects reported by participants receiving the medication were insomnia, headaches, and akathisia.

Similar to other atypical antipsychotics used to treat schizophrenia, Aristada comes with a boxed warning alerting health care professionals about an increased risk of death associated with off-label use of the medication to treat behavioral problems in older adults with dementia-related psychosis. To date, no atypical antipsychotic has been approved to treat dementia-related psychosis.

According to a press release by Alkermes Plc, the manufacturers of Aristada, the newly approved antipsychotic is being prepared to be launched “immediately.”

Chantix Not Associated With Increased Risk of Cardiovascular, Psychiatric Events, Study Finds

The smoking cessation drug varenicline (marketed as Chantix by Pfizer) does not appear to be associated with an increased risk of cardiovascular or psychiatric events when compared with other nicotine replacement treatments, according to a study published in the October issue of the Lancet Respiratory Medicine.

The study tracked over 160,000 patients who received a prescription for a nicotine replacement treatment (NRT), the anti-smoking drug bupropion, or varenicline for up to six months to compare incidence of depression, self-harm, and cardiovascular events.

At study completion, the results showed that people taking varenicline were no more likely to suffer a heart attack or develop depressive symptoms than those on an NRT or bupropion. In fact, the researchers found that varenicline was associated with a significantly reduced risk of ischemic heart disease, cerebral infarction, heart failure, arrhythmia, depression, and self-harm.

Since the initial marketing of varenicline in 2006, it has been at the center of nearly 3,000 lawsuits allegedly claiming that use of the drug causes serious adverse events. All lawsuits were settled by the company in 2013.

Oral Cannabidiol Boosts Response to Antipsychotic Treatment

G.W. Pharmaceuticals recently announced positive results from its phase 2a trial of oral cannabidiol (CBD) intended as an adjunctive therapy to antipsychotics for the treatment of schizophrenia.

The six-week, double-blind, placebo-controlled trial included 88 patients with schizophrenia who had previously failed to adequately respond to first-line antipsychotic medications. Patients remained on their antipsychotic medication during the trial while being randomized to receive 500 mg of CBD or placebo twice a day.

Results showed that as an adjunctive therapy to antipsychotics, CBD was consistently superior to placebo, with the most notable differences in the positive subscale of the Positive and Negative Symptom Scale, Clinical Global Impression of Severity, and Clinical Impression of Improvement. The most common adverse events reported by patients included diarrhea, nausea, headache, and somnolence.

The company announced that it will conduct further studies based on the current findings and future studies exploring the effectiveness of CBD in rare neuropsychiatric conditions that affect children.

FDA Requests Change to Zoloft’s Warnings

The FDA has asked Pfizer to modify its labeling for the antidepressant Zoloft (sertraline) to acknowledge data that suggests infants whose mothers took the medication may be at an increased risk of heart defects. The agency is specifically asking for the label of the antidepressant to include warnings from researchers who found prenatal use of Zoloft to be associated with “increased risk of congenital cardiac defects” in infants, according to company court papers obtained by Bloomberg.

Although the majority of studies investigating the safety of Zoloft found that it did not increase risk for major birth defects in the offspring of women taking the drug, the medication’s current label reads that there are “no adequate and well-controlled studies of pregnant women,” according to Bloomberg.

Pfizer has maintained that Zoloft does not cause congenital heart defects in infants and that its label warns women and their doctors about the medication’s risk.

The company is facing hundreds of lawsuits by women who say they were not adequately warned the drug would cause defects in their newborns. The company was exculpated of these claims in two court cases in St. Louis and Philadelphia earlier this year. ■