Injection Posimir available for relief of pain after shoulder surgery

Posimir (bupivacaine solution) is now commercially available for providing postsurgical analgesia up to 72 hours following arthroscopic subacromial decompression. Posimir is supplied in 5mL ready to use single-dose vials containing 660mg of bupivacaine solution. The product does not require dilution or mixing.

POSIMIR® (bupivacaine solution) for infiltration use is a novel and proprietary product that combines the strength of 660 mg of bupivacaine base with the innovative SABER® platform technology, enabling continuous sustained delivery of a non-opioid local analgesic over 3 days in adults.

POSIMIR contains more bupivacaine than any other approved single-dose sustained-release bupivacaine product. At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more.

The most common adverse reactions reported with Posimir administration in shoulder surgery were dizziness, dysgeusia, dysuria, headache, hypoesthesia, paresthesia, tinnitus, and vomiting.

"We are pleased that Innocoll, with its dedicated hospital sales and marketing organization, has launched POSIMIR in the United States and recorded its first sales," added James E. Brown, President and Chief Executive Officer of DURECT Corporation. "Bringing a new non-opioid analgesic option with POSIMIR is a welcome next step in the evolution of pain management for patients."

Per the terms of the collaboration between Innocoll and DURECT, Innocoll will make a $2 million payment to DURECT triggered by the first commercial sale of POSIMIR. Previously, in August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage of POSIMIR to at least 2041, resulting in an $8 million milestone payment by Innocoll to DURECT.

These payments are in addition to the $4 million upfront license fee received in January 2022. As the launch progresses, DURECT will receive tiered, low double-digit to mid-teen royalties on net product sales in the United States, as well as additional milestone payments up to $122 million in the aggregate, depending on the achievement of certain commercial, regulatory and intellectual property milestone payments with respect to POSIMIR.

In addition to the exclusive right to develop and commercialize POSIMIR in the United States, Innocoll also has been granted the right to conduct additional development activities to expand the approved indications for POSIMIR, and DURECT's contract manufacturing supply agreement for POSIMIR has been assigned to Innocoll. DURECT retains all commercial rights to POSIMIR throughout the rest of the world.