FDAnews Drug Daily Bulletin
Pharmaceuticals / Postmarket Safety

FDA Puts Hold on Clinical Trials of Cognitive Treatment Encenicline

Sept. 22, 2015

FDA has placed a hold on clinical trials of long-term cognitive treatment encenicline after some patients experienced serious gastrointestinal concerns, Forum Pharmaceuticals and its Japanese partner reported.

While the company says there were a few cases involving negative reactions, its studies of encenicline’s effect on Alzheimer’s disease have been shut down with both medication and patient enrollment halted. Forum has a licensing agreement with Japan’s Mitsubishi Tanabe Pharma Corp. to develop the drug for Asian nations.

Forum intends to get back on track with its research by cooperating with the FDA to develop risk reduction strategies.

The company will be allowed to continue two Phase 3 trials of the drug examining its effectiveness in treating cognitive impairment in schizophrenia. The Phase 3 study results are expected by summer 2016.

Forum says encenicline stimulates brain networks by binding to an alpha 7 receptor that works with a natural neurotransmitter. The goal is to boost the brain’s reaction to the transmitter and improve memory, attention, executive function, understanding and comprehension in patients with reduced mental capacity.

Earlier this year, the FDA stressed the need for targeted drug development and collaborations addressing diseases, including Alzheimer’s, that are still little-understood. — Victoria Pelham