Akela Pharma Inc has received a letter from the U.S. Food and Drug Administration that its six-month inhalation toxicology studies for its lead product were deemed invalid due to GLP (Good Laboratory Practice) deviations.
Akela Pharma Inc. a drug development company focused on developing therapies for the inhalation and pain markets, today announced that it has received notice from the FDA that, due to GLP deviations the 6-month inhalation toxicology studies were deemed invalid.
The drug developer said no toxicological reasons were cited and is evaluating several alternative remedies. It said it is confident that the submission for regulatory approval will not be delayed by more than six months.
Fentanyl Taifun is Akela's lead product for the treatment of breakthrough cancer pain and is a formulation of pain reliever Fentanyl delivered using the company's Taifun dry powder inhaler platform.