Local Tech Wire
RALEIGH, N.C. – Drug development firm (Nasdaq: BDSI) can now sell its powerful painkiller Onsolis in Canada.
The company said Monday it had received regulatory approval from Health Canada. The U.S. Food and Drug Administration approved Onsolis last July.
BDSI is also seeking approval to sell the powerful drug in Europe.
A patch that delivers an opiate pain killer, Onsolis is designed to dissolve in a patient’s cheek. It is intended to treat so-called “breakthrough,” or sever pain in cancer patients.
Onsolis utilizes proprietary technology at BioDelivery called BEMA, or bioerodible muco adhesive. It is BDSI’s first product.
Onsolis will be sold in Canada by Meda Valeant Pharma Canada, which is a joint venture between Meda AB and Valeant Canada Limited. Meda is also a commercial partner of BDSI. BDSI will receive double-digit royalties on sales.
“The regulatory approval of ONSOLIS in Canada represents the culmination of a great collaborative effort between BDSI, Meda, and Valeant,” said BDSI Chief Executive Officer Mark Sirgo in a statement.
“Onsolis provides an important new option to manage the potentially debilitating effects of breakthrough pain in opioid-tolerant individuals with cancer,” he added.
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