BioCentury
ARTICLE | Clinical News

Durect, Pain jump on Pfizer's Remoxy green light

October 23, 2013 12:48 AM UTC

Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics Inc. (NASDAQ:PTIE) jumped on Tuesday after partner Pfizer Inc. (NYSE:PFE) said it will continue to develop Remoxy oxycodone, a high viscosity capsule formulation of oxycodone formulated with Durect's Oradur technology. Pfizer said it will conduct the additional clinical studies required to address a June 2011 complete response letter from FDA, including a study to compare bioequivalence of the modified and original formulations of Remoxy and an abuse-potential study. The pharma reiterated that it does not expect to submit a response to the Remoxy letter before mid-2015 (see BioCentury Extra, Aug. 16).

In May, shares of Durect and Pain fell after Pfizer said there is "much to consider" before making a go/no-go decision to continue developing Remoxy. The companies got a bump in August after Pfizer registered a bioequivalence study for Remoxy on clinicaltrials.gov, but at the time Pfizer said it still had not made a decision to continue development (see BioCentury Extra, May 10). ...