BioDelivery Sciences International now expects its breakthrough cancer pain treatment to return to the market in 2016—seven years after the FDA first approved the company’s drug.
Raleigh, NC-based BioDelivery Sciences (NASDAQ: BDSI) said Thursday that the FDA granted the company supplemental approval on a new formulation of Onsolis. The drug administers the painkiller fentanyl through a proprietary film that slowly dissolves when placed on the inside of the cheek.
BDSI needed to develop a new Onsolis formulation after the FDA expressed concerns in 2012 that a color change in the product over time could confuse patients. The FDA raised no concerns about the product’s safety or efficacy. BDSI addressed the problem by removing a non-active ingredient responsible for the color change. But BDSI could not make or sell any more Onsolis until the FDA approved the new formulation.
The holdup on Onsolis translated into a lot of lost sales at a time when BDSI had no other FDA-approved products. BDSI last recorded revenue for the drug in 2011. The delays also cost BDSI a marketing deal. Swedish pharmaceutical company Meda Pharmaceuticals in January returned to BDSI its U.S. rights to the drug, as well as the rights to pursue commercialization of the drug in Canada and Mexico. BDSI’s relationship with Meda to develop and commercialize Onsolis dates back to 2006.
Meda still retains European rights to the drug, where it is marketed under the name Breakyl. The drug is also available in Taiwan and South Korea under separate licensing agreements with different partners.
Though BDSI holds U.S. rights to its cancer pain treatment and now has the FDA go-ahead to sell it, the company’s preferred next step is to land a new marketing partner. In a conference call earlier this week to discuss second quarter financial results, CEO Mark Sirgo said BDSI continues to receive “inquiries from parties interested in licensing the product from us.” He added that he expects the drug would become available again in the United States in 2016.
BDSI has two other products that employ the same drug delivery technology as Onsolis. Bunavail, a treatment for opioid addiction, launched earlier this year. BDSI also has a partnership with Endo International (NASDAQ: ENDP), which licensed the North Carolina company’s chronic pain treatment, Belbuca. An FDA decision on that product, which administers the painkiller buprenorphine, is expected this fall.
Photo courtesy of Flickr user Joel Kramer under a Creative Commons license.