BDSI most cancers pain Drug authorized once more, Search Continues for brand new partner
BioDelivery Sciences international now expects its breakthrough cancer ache therapy to return to the market in 2016—seven years after the FDA first approved the corporate’s drug.
Raleigh, NC-primarily based BioDelivery Sciences (NASDAQ: BDSI) said Thursday that the FDA granted the corporate supplemental approval on a brand new method of Onsolis. The drug administers the painkiller fentanyl through a proprietary film that slowly dissolves when positioned on the inside of the cheek.
BDSI wanted to increase a brand new Onsolis formula after the FDA expressed concerns in 2012 that a color alternate within the product over time may confuse patients. The FDA raised no issues concerning the product’s security or efficacy. BDSI addressed the issue through getting rid of a non-active ingredient accountable for the color alternate. but BDSI could now not make or sell any further Onsolis except the FDA licensed the new formulation.
The holdup on Onsolis translated into a lot of misplaced gross sales at a time when BDSI had no other FDA-approved products. BDSI last recorded revenue for the drug in 2011. The delays also price BDSI a advertising deal. Swedish pharmaceutical company Meda prescribed drugs in January lower back to BDSI its U.S. rights to the drug, in addition to the rights to pursue commercialization of the drug in Canada and Mexico. BDSI’s relationship with Meda to boost and commercialize Onsolis dates again to 2006.
Meda still retains European rights to the drug, the place it’s marketed underneath the title Breakyl. The drug is also on hand in Taiwan and South Korea underneath separate licensing agreements with totally different companions.
although BDSI holds U.S. rights to its cancer pain therapy and now has the FDA go-beforehand to promote it, the corporate’s most well-liked next step is to land a brand new advertising accomplice. In a convention call previous this week to talk about 2d quarter financial outcomes, CEO Mark Sirgo stated BDSI continues to obtain “inquiries from parties inquisitive about licensing the product from us.” He delivered that he expects the drug would grow to be to be had once more in the united states in 2016.
BDSI has two different products that hire the same drug delivery technology as Onsolis. Bunavail, a treatment for opioid addiction, launched previous this 12 months. BDSI also has a partnership with Endo global (NASDAQ: ENDP), which licensed the North Carolina firm’s persistent pain remedy, Belbuca. An FDA decision on that product, which administers the painkiller buprenorphine, is predicted this fall.
photo courtesy of Flickr consumer Joel Kramer beneath a creative Commons license.
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