BioTuesdays - DURECT awaiting Pfizer meeting with FDA on Remoxy
DURECT (NASDAQ:DRRX) has a lot riding on a meeting in late March between its marketing partner, Pfizer, and the FDA to discuss resubmitting a new drug application for its lead pain drug, Remoxy, as a tamper-resistant formulation of oxycodone, a powerful opioid that is widely abused.
“Based on the feedback Pfizer receives from the FDA at that meeting, Pfizer will determine the next steps and/or required timing to respond to the Complete Response Letter for Remoxy,” Matt Hogan, CFO of DURECT, says in an interview with BioTuesdays. He gave this interview following his presentation at the BIO CEO conference in New York earlier this month.
“We will support Pfizer however we can as they complete whatever is required for the resubmission, and, once the NDA is resubmitted, it should undergo a six-month review by the FDA,” he adds.........