The FDA approved patch is currently indicated to provide local dermal analgesia for superficial venous access and superficial dermatological procedures, such as excision, electrodessication and shave biopsy of skin lesions.
Galen US general manager Andrew Shales said the acquisition of US rights of Synera will help address an important medical need in the field of local dermal analgesia, especially in children three years or older.
"Indeed, demand is stoked by hospitalized patients being routinely subjected to multiple superficial venous access procedures such as IV infusions and blood draws," Shales added.
As per terms of the agreement, which was inked with Nuvo’s wholly owned subsidiary ZARS Phama, an upfront payment of $4.5m has been made by Galen to Nuvo.
In addition to royalties of 10% of net sales, Nuvo will be eligible to receive $5m milestone payment on posting $25m gross annual sales and a further $5m upon reaching $50m gross annual sales.
Nuvo will hold the right to develop and seek FDA approval for future additional indications, including acute musculoskeletal pain.