FDA Panel Rejects Pimavanserin for Alzheimer’s Psychosis

A US Food and Drug Administration (FDA) advisory panel has rejected the atypical antipsychotic pimavanserin (Nuplazid, Acadia Pharmaceuticals) for the treatment of Alzheimer’s disease psychosis (ADP). In a 9-3 vote, the Psychopharmacologic Drugs Advisory Committee (PDAC) found that the drug’s manufacturer failed to offer convincing evidence of its efficacy in patients with ADP. Today’s rejection … Read more

Genetic Testing for Best Antidepressant Accurate, Cost-Effective

Genetic testing to determine the best antidepressant for patients with major depressive disorder (MDD) has the potential to lead to an optimal drug choice on the first try and reduce healthcare costs, new research suggests. CYP2D6 and CYP2C19, from the cytochrome P450 family, are involved in the metabolism and elimination of various molecules, including medications. … Read more

FDA Denies Petition to Disqualify Researchers Over Controversial Ketamine Studies

The US Food and Drug Administration (FDA) has declined to take further action against a group of investigators at Hennepin County Medical Center/Hennepin Healthcare (HCMC), who conducted controversial studies involving ketamine and other sedatives in agitated persons without their consent. A citizen filed by Public Citizen, a consumer advocacy group, had asked the FDA to … Read more

Docs Check Mail for Ways to Return — and Ruin — Extra Opioids

Mail carriers could play a key role in reducing opioid misuse, according to researchers and regulators. One strategy under consideration by the US Food and Drug Administration (FDA) would require that opioid analgesics be dispensed with prepaid mail-back envelopes so patients can return leftover medication. Another approach — which is not part of the FDA … Read more

New Med for Severe Mental Illness Tied to Less Weight Gain

Olanzapine plus samidorphan (Lybalvi) vs olanzapine alone is associated with less weight gain while achieving similar clinical outcomes in patients with recent-onset severe mental illness, new research suggests. However, least one expert says the weight difference between the two drugs is of “questionable clinical benefit.” Last year, the US Food and Drug Administration (FDA) approved … Read more

Medications for Opioid Addiction Vastly Underutilized

Despite a record number of drug overdose deaths in the US and a large body of evidence supporting the efficacy of medications to treat opioid use disorder (OUD) these drugs remain vastly underutilized, new research shows. Based on data from the National Survey on Drug Use and Health (NSDUH), investigators found only one in four … Read more

FDA, DEA Pushed to Make Gabapentin a Controlled Substance

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance. The nonprofit group Public Citizen has filed a petition with the US Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA), arguing that medication’s risks additional safeguards. … Read more

Prescription Video Game Focuses Attention in ADHD

A prescription, digital therapeutic shows measureable brain changes that correlate with improved attention control in children with attention hyperactivity disorder (ADHD). Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention. “While the … Read more

APA, Others Seek FDA Forum on REMS

Multiple psychiatric groups have asked the US Food and Drug Administration (FDA) to consider holding a public meeting about its approach to risk management of the schizophrenia drug clozapine, which is effective but carries serious risks, including death. In a February 14 letter, the groups asked the FDA to reconsider its new risk evaluation and … Read more

High Praise, Condemnation for CMS Aduhelm Coverage Plan

Medicare has received a key endorsement of its plan to restrict payment for the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) — but also drew pleas from other groups for more generous reimbursement of the drug, as well as expected similar medications currently in development . The Centers for Medicare & Medicaid Services (CMS) received … Read more