FDA designation may speed new treatment for Alzheimer’s psychosis

The U.S. Food and Drug Administration (FDA) has granted fast track designation to remlifanserin, an experimental treatment that Acadia Pharmaceuticals is developing for hallucinations and delusions associated with Alzheimer’s disease psychosis.

The FDA grants this designation to investigational medicines intended to treat serious conditions and fill an unmet medical need. Fast track status provides benefits such as more frequent communication with the FDA, with the goal of speeding a therapy’s development and review.

“FDA Fast Track designation for remlifanserin underscores the significant unmet need for new treatment options for people living with Alzheimer’s disease psychosis, a serious condition for which there are currently no FDA-approved therapies. This is an important milestone for the remlifanserin program,” Catherine Owen Adams, CEO of Acadia, said in a company press release.

Psychosis can involve hallucinations, such as seeing or hearing things that aren’t there, and delusions, which are fixed beliefs not based in reality. Psychosis is thought to involve imbalances in brain signaling that can cause certain nerve cells to become overly active. Altered serotonin signaling has also been linked to psychosis.