Med Check
FDA Concludes Benefits of Nuplazid Outweigh Risks
The Food and Drug Administration (FDA) in September completed a review of postmarketing data of adverse events related to the use of Nuplazid (pimavanserin), which is approved for the treatment of Parkinson’s disease psychosis. The review was initiated after several reports of death and other serious side effects associated with Nuplazid were published earlier this year.
“Overall, the postmarketing data were consistent with the safety data obtained from the premarketing controlled clinical trials of Nuplazid for Parkinson’s disease psychosis,” the agency wrote in a press release. “After a thorough review, FDA’s conclusion remains unchanged that the drug’s benefits outweigh its risks for patients with hallucinations and delusions of Parkinson’s disease psychosis.”
In conducting its review, the FDA factored in that patients with Parkinson’s disease psychosis generally are older, have more advanced Parkinson’s disease, and are more likely to have other medical problems—all of which contribute to mortality risk. In addition, the agency noted that many of the deaths entered in the FDA Adverse Event Reporting System did not provide enough information to assess whether Nuplazid was a cause of the mortality.
While the FDA did not identify any new or unexpected safety risks, some potentially concerning prescribing patterns were observed, such as the concomitant use of Nuplazid with other antipsychotic drugs or drugs that can cause QT prolongation—a risk factor for arrhythmia.
The release stated: “FDA reminds health care providers to be aware of the risks described in the prescribing information. FDA also reminds health care providers that none of the other antipsychotic medications are approved for the treatment of Parkinson’s disease psychosis.”
Harmony Biosciences Details Long-Term Safety, Efficacy of Narcolepsy Drug
Harmony Biosciences in September presented positive long-term data on its investigational drug pitolisant, which is in development for the treatment of excessive daytime sleepiness and cataplexy (sudden muscle weakening) in adults with narcolepsy. Pitolisant is a potent and selective modulator of the histamine 3 receptor.
The data came from 48 narcolepsy patients who participated in an open-label, five-year follow-up of the Harmony III safety and efficacy trial. The participants took 40 mg pitolisant once daily during the follow-up; 32 patients remained enrolled for the full five-year period.
The study found that the participants showed continual sleep improvements over the course of five years. Daytime sleepiness, as measured by the Epworth Sleepiness Scale, improved from 16.8 at baseline to 13.4 after one year and 10.6 after five years.
Following one year of treatment, the participants also saw reduced cataplexy (76 percent decline), drowsiness-related hallucinations (54 percent decline), and sleep paralysis (62 percent decline). Harmony noted that there were limited data from patient sleep diaries at the five-year mark to assess long-term changes in these symptoms.
The safety and tolerability profile of pitolisant was consistent with that reported in previous short-term clinical trials.
FDA-Approved Cannabidiol Reclassified as Schedule V Drug
The Drug Enforcement Administration (DEA) in September moved the recently approved seizure medication Epidiolex from Schedule I to Schedule V of the Controlled Substance Act (CSA)—the least restrictive schedule of the CSA. This move paves the way for GW Pharmaceuticals to market this cannabis-derived treatment.
In June, Epidiolex was approved by the FDA for the treatment of seizures associated with two rare and severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.
The DEA’s decision to move Epidiolex to Schedule V was based on both clinical and nonclinical data demonstrating a low potential for abuse. Drugs classified in Schedule V are considered to have low abuse potential as well as proven medical uses. The DEA noted that this reclassification only applies to Epidiolex; other cannabidiol-based products will remain as Schedule I drugs, which are considered illegal.
“DEA will continue to support sound and scientific research that promotes legitimate therapeutic uses for FDA-approved constituent components of cannabis, consistent with federal law,” said Acting DEA Administrator Uttam Dhillon in the agency’s press release.
FDA Will Consider Vraylar for Bipolar Depression
Allergan Inc. announced in September that the FDA has agreed to review the company’s supplemental New Drug Application (sNDA) for Vraylar (cariprazine). The sNDA seeks to expand the medication’s indication to include the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
Cariprazine was approved by the FDA in September 2015 for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, as well as for the treatment of schizophrenia in adults.
Allergan’s sNDA is supported by data from three clinical trials. In all of the trials, patients with bipolar depression who received cariprazine (1.5 mg or 3 mg doses) experienced greater improvements in depressive symptoms after six weeks compared with those who received placebo (as measured with the Montgomery Åsberg Depression Rating scale).
Cariprazine was generally well tolerated in the trials. The most commonly reported adverse events were nausea, akathisia, restlessness, and upper respiratory tract infection. ■
Information & Authors
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Published In
Psychiatrics News
History
Published online: 2 November 2018
Published in print: October 20, 2018 – November 2, 2018
Keywords
- Nuplazid
- pimavanserin
- Parkinson’s disease
- psychosis
- Food and Drug Administration
- FDA Adverse Event Reporting System
- Harmony biosciences
- pitolisant
- narcolepsy
- cataplexy
- cannabidiol
- Epidiolex
- Epilepsy
- Drug Enforcement Agency
- DEA
- Supplemental New Drug Application
- sNDA
- cariprazine
- Vraylar
- bipolar depression
- bipolar disorder
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