The US Food and Drug Administration (FDA) has approved Onsolis, referred to as BEMA Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer.
The FDA granted approval to BioDelivery (BDSI) and Meda for the drug to manage BTP in patients with cancer aged 18 and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
Onsolis is the first product to utilise the company’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small dissolvable polymer film for application to the inner lining of the cheek.
BDSI president and CEO Mark Sirgo said that the approval of Onsolis is a landmark and transformational event for the company.
“All of us at BDSI, along with our partner Meda, are very pleased to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition,” Sirgo said.
As per the agreement, BioDelivery will receive an aggregate of approximately $27m in milestone payments. The first is based on FDA approval of Onsolis, for the amount of approximately $12m.
Meda had already advanced the company $3m in January 2009, against the $15m milestone payment.
A second payment of $15m will be received following the manufacture of launch stocks of Onsolis, a target the company has also achieved. In addition, BDSI will receive a double-digit royalty on net sales as well as the potential for up to another $30m in milestone payments based on certain sales thresholds.