BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, has received the regulatory approval of Onsolis in Taiwan for the management of breakthrough cancer pain in opioid tolerant, adult patients with cancer.

In Taiwan, BDSI has licensed the commercialisation rights to TTY Biopharm, where the product will be marketed under the brand name Painkyl. TTY will be responsible for the cost of future product commercialization in Taiwan and expects to launch Painkyl following receipt of reimbursement pricing from the Taiwanese national healthcare system. The approval in Taiwan results in a milestone payment of $300,000 to BDSI. Upon launch, BDSI will receive a royalty on net sales.

"We offer our thanks and congratulations to our partner TTY on the regulatory approval for this product, which will be the first drug available in Taiwan for the treatment of breakthrough cancer pain," said Dr Andrew Finn, executive vice president of Product Development at BDSI.

Onsolis is approved in the US and Canada for the treatment of breakthrough pain in opioid-tolerant adult patients with cancer and marketed in the EU as Breakyl. The commercialisation rights are licensed to Meda for all territories world-wide with the exception of Taiwan and South Korea. In South Korea, the product is licensed to Kunwha Pharmaceutical Co.

BDSI is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction.