BioDelivery Sciences International, inc. (NASDAQ: BDSI) remains on schedule to meet with the Food And Drug Administration, on Nov. 17 to discuss its Risk Evaluation and Mitigation Strategy for ONSOLIS, its main cancer pain treatment drug.
The company said it has already sent the FDA the information it needs, in advance preparation for the meeting. ONSOLIS (formerly known as BEMA Fentanyl) is for patients who are opoid tolerant. It’s the company’s lead development product.
“Our proposed REMS program will be an important step in helping to assure that prescribers and patients get the benefits of ONSOLIS while minimizing the risks of improper or inappropriate use,” said Dr. Mark A. Sirgo, BDSI president and CEO.
Quality Stocks has kept its eye on BDSi for a while. Biodelivery Sciences is a specialty pharmaceutical company focused on developing products to address growing market opportunities, including conditions such as pain.
In August, The FDA requested conversion of the submitted risk minimization action plan (RiskMAP) to a REMS and told BioDelivery Sciences all other aspects of its New Drug Application were complete.
“We are confident that our proposed REMS program is consistent with the advice we received in our Complete Response letter,’ Dr. Sirgo said, “and we are hopeful that this will allow for a quick submission following what we anticipate will be a productive meeting with FDA.”
After the meeting, BDSI expects to resubmit its application in December and receive approval in the first half of 2009.
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