Raleigh-based BioDelivery Sciences (Nasdaq: BDSI) will receive a $10 million milestone payment from partner Endo Pharmaceuticals now that the FDA has accepted a new drug application for the severe pain reliever system known as Belbuca.
The companies announced the news early Monday before the stock markets opened.
“The FDA’s acceptance of our Belbuca NDA is a significant milestone for BDSI and in our partnership with Endo,” said Mark Sirgo, BDSI’s chief executive officer. “We believe that Belbuca can offer those suffering with chronic pain with a novel treatment approach. We look forward to continuing our work with Endo, and making this therapy available to patients who need it.”
The FDA approved the name Belbuca as well.
BDSI owns proprietary “BioErodible MucoAdhesive” or BEMA, and other technologies for oral delivery of medications (See graphic with this post for an explanation.)
The company launched sales of another product, Bunavail, in November of 2014.
If Belbuca wins FDA approval, BDSI would receive as much as $50 million in additional payments.
Belbuca could be approved as early as October, according to BDSI.
Here’s how Belbuca works, according to the company:
“Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes most opioid analgesics. Buprenorphine is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action. BELBUCA is being developed and will be commercialized through a worldwide license and development agreement between Endo Pharmaceuticals and BDSI.”
