The U.S. Food and Drug Administration on Thursday formally approved Onsolis, Raleigh-based BDSI's mouth patch that delivers the painkilling drug fentanyl to cancer patients suffering severe “breakthrough pain” that doesn't respond to other medications.
Onsolis is manufactured by Aveva Drug Delivery Systems of Florida and marketed under license from BDSI (Nasdaq: BDSI) by Meda Pharmaceuticals. With FDA approval of Onsolis, BDSI is due about $27 million in milestone payments, which Sirgo said would be directed to the company's drug pipeline.
The company also is developing the product BEMA Buprenorphine, a form of painkilling drug buprenorphine that is often given intravenously to treat chronic pain. Like Onsolis, the product uses the company's BEMA technology, which delivers drugs through mucous membranes in the mouth via a small patch.
Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.