Pain Therapeutics chides FDA for 'shambolic' abuse-deterrent regulations

Pain Therapeutics Inc. (NASDAQ:PTIE) said FDA's regulatory procedures for gaining approval of abuse deterrent products lacks predictive pathways for development and commercialization. The company's comments Tuesday follow a Jan. 31 meeting with FDA to discuss an NDA seeking approval of pain therapy Remoxy ER oxycodone extended release with abuse-deterrent properties.

Pain said it met with FDA to resolve disagreements around comments the agency made in 2018 during its review of the company’s NDA, and FDA's conclusion that Remoxy lacks abuse deterrent properties. FDA issued its fourth complete response letter to Remoxy in August 2018. The company noted that the safety and efficacy of Remoxy are not in question. ...