Med Check

FDA Approves Antipsychotic Lasting Three Months

The FDA has approved Invega Trinza (paliperidone palmitate), a long-acting atypical antipsychotic intended to treat schizophrenia, from Janssen Pharmaceuticals Inc.

The approval of the injectable antipsychotic, which remains active in the body for three months, was based on results from a two-year maintenance trial with 506 patients diagnosed with schizophrenia. The analysis, published March 29 in JAMA Psychiatry, showed that patients who were administered Invega Trinza were statistically less likely to relapse than those who were administered placebo. The most common adverse effects of the medication included injection-site reactions, weight gain, upper respiratory tract infections, and extrapyramidal symptoms.

The newly approved antipsychotic will come with a boxed warning stating that it is not approved for patients with dementia-related psychosis and that use of the drug may increase the risk for death in elderly patients with dementia.

Before patients can begin taking Invega Trinza, they must first show tolerability to Janssen’s Invega Sustenna, a one-month form of paliperidone palmitate, for at least four months.

Invega Trinza was approved under the FDA’s priority review process, a fast track for drugs thought to represent a significant advance in medical care. It is being marketed by Janssen.

Otsuka Denied Exclusive Rights To Market Abilify

In May, the U.S. District Court for the District of Maryland denied Otsuka Pharmaceutical’s motion for a preliminary order blocking generic versions of Abilify after the company filed suit against the Food and Drug Administration for denying Otsuka exclusive rights to make Abilify until 2021.

Otsuka argued that Abilify was designated an orphan drug—a drug that treats rare conditions—when it was approved for pediatric Tourette’s syndrome. The FDA gives several extra years of exclusivity to an orphan drug due to the drug’s high cost of development, which may make the product less profitable than other drugs used to treat less rare conditions.

U.S. District Judge George Hazel said that since Abilify has nonpediatric uses, which are not protected by the orphan-drug status, development of generic versions of the drug can proceed.

Abilify is approved to treat schizophrenia and bipolar disorder and lost its patent protection for those uses in April.

Combined Therapy Announced For Treatment of Alzheimer’s

Actavis announced that its new therapy, Namzaric, is being marketed to treat moderate to severe Alzheimer’s disease.

Namzaric is a once daily, fixed-dose of memantine hydrochloride extended-release (an NMDA receptor agonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor). The newly marketed product is available in two strengths 28/10 mg (memantine HCl ER/ donepezil HCl) and 14/10 mg for patients with severe renal impairment. The most common adverse reactions reported by patients taking the medication include headache, dizziness, and diarrhea.

Both memantine hydrochloride extended-release, marketed as Namenda, and donezepil hydrochloride, marketed as Aricept, are approved for the treatment of moderate to severe dementia associated with Alzheimer’s disease. Namzaric is a joint effort between Actavis and Adamas Pharmaceuticals.

California Senate Looks to Reduce Psychotropic Use in Foster Care

Last month, the California state Senate unanimously approved four bills aiming to curb the use of psychotropic medications for youth in the foster system. The bills seek to improve how the state’s juvenile courts approve psychotropic prescriptions, require periodic reporting of how often foster children are being medicated, and create new training programs for those providing medical treatment to foster children.

According to a series of investigative reports published in the San Jose Mercury News, almost one in four California teens in foster care has been given psychotropic drugs over the past decade, the vast majority receiving antipsychotics.

Under the proposed laws, social workers would be alerted when youth receive multiple medications or high dosages and when psychiatric drugs are prescribed to very young children.

Mercury News reports that though the legislation has no formal opposition, some child psychiatrists have expressed concerns that too many new rules could hinder care when access to medication is vital.

Combined Use of Antidiabetic, Antidepressant Medications Increases Risk for MI

Scientists from Sweden and Australia analyzed health records of four million Swedish residents aged 45 to 84 to assess the gender-specific risks of developing a first myocardial infarction in people being treated with antidiabetic and/or antidepressant drugs.

The results, published in the journal Diabetic Medicine, showed that women aged 45 to 64 who were taking both antidiabetic and antidepressant medications were more than seven times more likely to experience a myocardial infarction than women who were taking neither medication, and two and six times more likely, respectively, to experience such an event than women taking an antidiabetic and antipsychotic alone. Men taking both medications were more than three times more likely to have had a myocardial infarction than men who took neither medication, and twice as likely to experience such an event as those taking an antidiabetic drug or antipsychotic alone.

The analysis also showed that women taking the combined medications were more than two times more likely to experience a myocardial infarction than their male counterparts.

“About 10 to 30 percent of patients with diabetes have a comorbid depressive disorder, which is double the estimated prevalence of depression in individuals without diabetes,” said lead author Karin Rådholm, M.D., Ph.D., in an interview with MedicalResearch.com. Based on the current findings, Rådholm emphasized that all patients, especially women with comorbid diabetes and depression, should be aware of any risk associated with taking both medications. ■