BioDelivery Sciences has received approval from the Food and Drug Administration for a new formulation of its treatment targeting breakthrough cancer pain. Now the company wants to find a partner to commercialize it.
News of the FDA approval sent BDSI (Nasdaq: BDSI) shares up 10 percent.
What to do next?
“We are pleased to have obtained FDA approval of our sNDA [supplemental new drug application] and to now be in a position to move toward returning Onsolis to the U.S. marketplace,” said Dr. Mark Sirgo, President and Chief Executive Officer. “Onsolis remains an important differentiated fentanyl containing product for this indication given that it is the only product for buccal administration, providing patients with an alternative dosing option.”
Onsolis is distributed orally through BDSI’s proprietary fentanyl buccal soluble film.
BDSI also recently hired two former executives at Salix Pharmaceuticals to help lead sales efforts.
The new formulation deals with concerns raised by the FDA about coloring.
BDSI needs a new partner after ending an agreement for marketing in the U.S. with Meda Pharmaceuticals. Meda still markets Onsolis outside of the U.S. except in Taiwan and South Korea.
“Although we have options for ONSOLIS, including commercializing it on our own, our current plan is to determine the value we can secure in a partnership with a company that has access to the target physician audience,” Sirgo said in a statement. “We have been engaged with a number of potential partners, and with this approval, we can now proceed forward with those discussions in earnest. We will provide more definitive timing in the near future about the reintroduction but this would not be prior to 2016.”
