A pain drug candidate from BioDelivery Sciences International (NASDAQ:BDSI) failed to perform better than a placebo in phase 3 clinical trials, according to preliminary trial results released by the biopharmaceutical company after the close of the financial markets Wednesday.
But Raleigh, North Carolina-based BDSI is not giving up on BEMA Bupenorphine, which the company was studying as a treatment for chronic pain. The company said it will start a second efficacy study “in the near future.” That study will take an estimated nine months to complete. CEO Mark Sirgo said in a statement that the company’s previously announced market projections for $500 million in peak sales should not change and the company “will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively.”
Investors saw otherwise and BDSI’s stock price plunged more than 39 percent to $1.85 in after hours trading.
BEMA Buprenorphine missed its first clinical trial target: an overall pain intensity difference between the BDSI drug and a placebo. But BDSI insists there is positive news in the results. The company said that there is a “near statistically significant difference” between its drug candidate and a placebo in the group of patients who have previous experience taking opioid medications. The company believes experience with opioid medications was the difference. In a statement, Dr. Andrew Finn, executive vice president of product development at BDSI, said that patients who don’t have experience with opioids had the higher placebo response.
Buprenorphine is already an approved drug for pain management. BDSI’s buprenorphine candidate delivers the drug with the company’s BEMA technology, which quickly delivers a dose via a small piece of film placed on the inside of the cheek. The BEMA technology is in use in the commercialized product Onsolis, which is used to deliver the pain-killing drug fentanyl to cancer patients experiencing breakthrough cancer pain.
BDSI will hold a conference call Thursday morning to further discuss the BEMA Buprenorphine trial results.