UPDATED: FDA agrees to review Endo Pharmaceutical's inside-the-cheek pain drug

Courtesy of BioDelivery Sciences

Endo Pharmaceutical's ($ENDP) investigational Belbuca buccal film strip for severe chronic pain has been accepted for review by the FDA, marking a win for the BioErodible MucoAdhesive technology to deliver drugs across mucosal surfaces like the inside of the cheek. And BEMA platform developer BioDelivery Sciences receives a $10 million milestone payment.

The specific indication of Belbuca up for review indicates that it is a second-line treatment. The candidate is indicated "for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate," according to the release.

Endo and BioDelivery are expecting to hear from the FDA in October, the Triangle Business Journal, covering North Carolina's Research Triangle, says. If approval is achieved, BioDelivery is in line for a $50 million payment, as well as royalties.

BioDelivery CEO Mark Sirgo told the Triangle Business Journal that he will use the milestone payment just received to support the company's recently approved pain killer Bunavail.

The development is a good example of the benefits of partnering in life sciences, especially within the drug delivery arena. Endo had failed to get the drug past a critical Phase III study prior to the partnership. But with Raleigh, NC-based BioDelivery's technology in tow, Endo's Phase III hit its primary endpoint when compared to a placebo. That triggered a separate $10 million milestone payment.

"The FDA's acceptance of our Belbuca NDA (New Drug Application) is a significant milestone for BDSI and in our partnership with Endo," said BioDelivery Sciences CEO Dr. Mark Sirgo in a statement. "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."

BioDelivery received $30 million for licensing BEMA to Endo in 2012. The deal will net BioDelivery up to $180 million over time as the candidate reaches clinical, manufacturing, distribution, marketing and sales milestones.

The Belbuca bioerodible film is placed on the inner lining of the cheek and delivers a dose of the drug buprenorphine across the mucous membrane in about 15 to 30 minutes, the companies say.

Ireland's Endo has suffered at the hands of pain generics recently, but the candidate has garnered sales estimates of about $300 million contingent upon the FDA approving the NDA.

- read the release
- the Triangle Business Journal's take

Editor's Note: This story has been updated to reflect additional information from the Triangle Business Journal.

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