DURECT Corporation (NASDAQ:DRRX) announced that PERSIST, the Phase III clinical study for POSIMIR® failed to meet its primary efficacy objective of drop in pain on movement over the initial 48 hours after surgery as against to standard bupivacaine HCl. While data trended in support of POSIMIR versus the comparator, they failed to record statistical significance. POSIMIR marks as an investigational drug candidate being advanced for the cure of post-surgical pain.
James E. Brown, the CEO and President of DURECT, expressed that they are extremely disappointed and surprised by this data, which we will be trying to comprehend more fully over the imminent weeks. They appreciate the initiatives of the patients and investigators who participated in PERSIST trial, and they appreciate Sandoz for their support.
POSIMIR marks as an investigational extended-release depot using DURECT’s patented SABER technology planned to continuously offer bupivacaine to the surgical site for time period of 72 hours to offer up to 3 days of continuous pain relief post-surgery. It is a drug candidate under advancement and has not been permitted for commercialization by the U.S. FDA or other health authorities.
In May 2017, Sandoz AG and DURECT finalized a license deal to market and develop POSIMIR in the U.S., and the deal became effective in June 2017. The company retains commercialization privileges in the rest of the world. As per the agreement terms, Sandoz did an upfront payment of $20 million, with the prospect in milestone payments for up to an additional $43 million based on successful advancement and regulatory milestones, and sales-based milestones of up to an additional $230 million.
DURECT is responsible for the conclusion of the underway PERSIST Phase III clinical study for POSIMIR as well as FDA communications through approval. The company also has specific manufacturing obligations under this deal. Sandoz will showcase exclusive commercialization rights in the U.S. upon regulatory nod with sole funding responsibility for commercialization plans.