Onsolis, which will be marketed as Breakyl, is indicated for the management of pain in opioid tolerant, adult patients with cancer.
BDSI’s Onsolis is expected to be marketed by its commercialization partner, Meda Valeant Pharma Canada in Canadian market.
BDSI president and CEO Mark Sirgo said the achievement of this important milestone provides an opportunity for growth of Onsolis outside of the US market, particularly where commercial efforts will not be impacted by a REMS requirement.
"We also look forward to introducing Onsolis into additional markets in the future," Sirgo said.