Regulators in the USA have given the green light to a new pain drug, Pacira Pharmaceuticals' Exparel, which is also good news for the UK's SkyePharma.
The US Food and Drug Administration has approved Exparel, which combines bupivacaine with Pacira's DepoFoam drug delivery technology, for postsurgical analgesia. The approval was based on a study which showed that Exparel demonstrated significant reductions in cumulative pain scores with an attendant decrease in opioid consumption for up to 72 hours.
Dave Stack, Pacira's chief executive, said that "as a non-opioid local analgesic, Exparel represents an evolution in the management of postsurgical pain by providing analgesia for several days with a single intraoperative infiltration". He added that the FDA approval is an important milestone for the firm, "as well as the millions of patients undergoing surgical procedures in the USA each year".
The Exparel approval will also benefit SkyePharma which os now in line to receive a $10 million launch milestone next year.
Pacira was set up in order to acquire SkyePharma's injectables business in 2007 initially for $20 million. Aside from the $10 million fee, the London-headquartered firm could also pocket up to $52 million in other contingent milestone payments and 3% of Exparel sales in the USA, Japan, the UK, France, Germany, Italy and Spain.