Encenicline trials placed on clinical hold for Alzheimers disease- Forum Pharma

After discussions with the FDA ,Forum Pharma (formerly Envio Pharma) was advised that studies investigating the use of encenicline in Azheimers disease have been placed on clinical hold. A small number of serious gastrointestinal safety events were reported in the AD studies that prompted the clinical hold. Forum Pharma has discontinued all study medication in the trials until the hold is lifted.Forum has also been advised that the long term extension trial in cognitive impairment in schizophrenia has been placed on clinical hold.

Two Phase III efficacy trials evaluating the use of encenicline in cognitive impairment will continue subject to vigilant monitoring of GI safety. Results from these studies will be available in early 2016.

Comment: A clinical hold does not necessarily spell the end of a drugs development and there have been examples of drugs where the hold is lifted after finding a patient population where the drug can have a safe effect.