Med Check

Beginning this month, the antidepressant Brintellix (vortioxetine) will be marketed in the United States under the name Trintellix, according to a statement released last month by Takeda Pharmaceuticals, which holds the license to market the drug in the United States, and Lundbeck, which manufactures the drug. This brand name change, which has been approved by the Food and Drug Administration (FDA), is in an effort to decrease the risk of prescribing and dispensing errors resulting from name confusion with the anti-blood clotting medication Brilinta (ticagrelor).  

No other changes will be made to the formulation, label, or packaging of the medicine. Because of the lag time associated with manufacturing bottles with the new brand name, the FDA has warned that health care professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period. To reduce the risk of name confusion during this transition, the FDA recommends prescribers include the generic name of the medication they are ordering.

Nuplazid (pimavanserin) tablets, manufactured by Acadia Pharmaceuticals Inc., last month became the first medication approved by the FDA to treat psychosis in patients with Parkinson’s disease (PDP).

Some studies suggest that up to 50 percent of all patients with Parkinson’s disease will experience hallucinations or delusions during the course of their illness—believed to be in part due to the elevated dopamine levels produced by common Parkinson’s disease medications. Pimavanserin is a selective-serotonin inverse agonist that preferentially targets 5-HT2A receptors, while avoiding activity at dopamine and other receptors commonly targeted by antipsychotics.

A trial of adults with PDP who were randomly assigned to take 40 mg of pimavanserin or placebo daily for six weeks revealed that those taking pimavanserin experienced fewer and less severe hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease. The most common adverse effects reported by patients taking pimavanserin included peripheral edema, nausea, and confusional state.

Nuplazid is expected to be commercially available this month, according to Acadia.

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Risk Management Advisory Committee in May voted 16-4 in favor of approving KemPharm’s Apadaz—a prodrug of hydrocodone and benzoic acidic combined with acetaminophen—for its proposed indication in treating acute pain, but voted against inclusion of an abuse-deterrent labeling for the product.

KemPharm claimed that evidence suggested the Apadaz would remain in an inactive state (prodrug) until it reached the intestinal tract where it would be converted to an active form of hydrocodone—thereby reducing the likelihood of the medication being snorted, injected, or smoked. However, the FDA disagreed with such claims, citing findings to suggest that Apadaz was hydrolyzed rapidly and completely before reaching the intestinal tract.

“[W]hile it is inevitable that there will be different points of view when evaluating new molecular entities with abuse-deterrent properties, we will continue to work collaboratively with the FDA to complete the review process of Apadaz,” KemPharm President and CEO Travis Mickle, Ph.D., said in a press announcement. 

The FDA in May issued a warning that the antipsychotic aripiprazole may increase compulsive or uncontrollable urges to gamble, binge eat, shop, and have sex.

The announcement comes after a search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature in the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002 revealed a total of 184 case reports (167 U.S. cases, which included adults and children) in which there was an association between aripiprazole use and impulse-control problems. The specific impulse-control problems reported include pathological gambling (n=164), compulsive sexual behavior (n=9), compulsive buying (n=4), compulsive eating (n=3), and multiple impulse-control problems (n=4).

All 167 FAERS cases reported that the patients experienced new urges leading to compulsive behavior only after starting aripiprazole treatment, and within days to weeks of reducing the dose or discontinuing aripiprazole treatment, all of the patients reported that the intense urges resolved. None of the patients had a history of pathological gambling, compulsive sexual behavior, binge eating, or compulsive shopping prior to starting aripiprazole treatment, and none were reported to have concurrent substance abuse disorder or symptoms of mania at the time they developed the impulse-control problems.

“Although pathological gambling is listed as a reported side effect in the current aripiprazole drug labels, this description does not entirely reflect the nature of the impulse-control risk that we identified,” the FDA stated in the announcement. “As a result, we are adding new warnings about all of these compulsive behaviors to the drug labels and the patient Medication Guides for all aripiprazole products,” including Abilify, Abilify Maintena, Aristada, and generics.

The FDA advises health care professionals to make patients and caregivers aware of the risks associated with aripiprazole when prescribing and ask patients who are taking the medication specifically about any new or increasing urges. The agency also recommends the close monitoring of patients at higher risk for impulse-control problems, including those with obsessive-compulsive disorder, bipolar disorder, substance use disorder, alcohol use disorder, or other addictive behaviors. Any side effects involving aripiprazole should be reported to the FDA MedWatch program. ■