Akela Pharma: FDA says toxicology studies for lead drug invalid

Feb 4 (Reuters) - Akela Pharma Inc (AKL.TO) said it 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.

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. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Himani Sarkar)