BDSI study fails to deliver, shares nosedive Print E-mail
By Staff and Wire Reports   
Wednesday, 28 September 2011 18:35
FDA CalendarShares of BioDelivery Sciences International, Inc. (Nasdaq:BDSI) began to tumble as soon as the company announced the preliminary findings a randomized, placebo-controlled, Phase 3 clinical study of BEMA Buprenorphine for the treatment of moderate to severe chronic pain in a mixed opioid naive and opioid experienced population.  

The stock was down big in after hours trading to $1.72 -1.34 (-43.79%) and BDSI management is scheduled to hold a conference call on Thursday, September 29th at 8:30 A.M. Eastern Time.

According to the company, the primary endpoint of the study, overall pain intensity difference between BEMA Buprenorphine and placebo, was not achieved; however, BDSI believes that the totality of the study results favors BEMA Buprenorphine, including a near statistically significant difference between BEMA Buprenorphine and placebo in the opioid experienced group of patients in the trial (p=0.067).  In addition, when eliminating the group of patients that did not titrate beyond the starting dose, a statistically significant difference between BEMA Buprenorphine and placebo (p=0.025) was identified.  With the knowledge gained from this study, the Company plans to initiate a second efficacy study in the near future that will take approximately nine months to complete.

"We witnessed a high placebo response in the opioid naive segment of our patient population, particularly at our starting dose, which accounted for the overall lack of efficacy that was observed in this trial," stated Dr. Andrew Finn, Executive Vice President of Product Development at BDSI.  "This group of patients, who are not accustomed to taking opioids and prone to higher placebo effects, accounted for nearly two-thirds of the total study population.  When we eliminate the BEMA Buprenorphine starting dose from the analysis, where the greatest placebo response occurred, particularly in the opioid naive group, we achieved a pain score difference between BEMA Buprenorphine and placebo that approached statistical significance (p=0.066).  This starting dose "phenomenon" is not dissimilar to what has been observed with other approved opioids."

Dr. Finn concluded, "We observed significant efficacy in the opioid experienced subset of patients and believe there is a clear pathway forward to determine the same in the opioid naive patients.  We are also pleased to see that the product was well tolerated and that no unexpected side effects were seen.  Our overall evaluation of the data in these two patient populations has given us valuable insight and confidence that we will use in commencing a new study."

"While there is disappointment over missing the primary efficacy endpoint of this study, the many positive findings we observed gives us great confidence in our ability to ultimately bring this product to market for the treatment of chronic pain in a variety of patient types," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. 


"Opioid naive and opioid experienced patients make up nearly 75% of all people requiring treatment for pain.  Our strategy was to capture both populations in our product label through the conduct of one trial rather than performing separate studies" continued Dr. Sirgo.  "We had an unusually high placebo response in the naive group of patients while the experienced group of patients responded as we had anticipated.  With some tightening of the study entry criteria and a few design adjustments, we are confident we can complete a successful trial." 


"In short, we know buprenorphine works in treating pain.  This opportunity has never been an "if" but a "when", and this study affirms our belief in this regard," continued Dr. Sirgo.  "We continue to believe that BEMA Buprenorphine has the opportunity to be the first transmucosal product for the treatment of chronic pain to reach the marketplace.  Our previously announced market projections for the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively.  We anticipate our partner discussions will also aid us in refining the design for our next study.  In summary, we firmly believe that the future of BEMA Buprenorphine for chronic pain, and for our company in general remains bright."

"Moreover, our stockholders should not lose sight of our equally exciting BEMA Buprenorphine/Naloxone product for the treatment of opioid dependence.  We plan to initiate our pivotal bioequivalence trial by the end of this year with data expected in the first quarter of 2012.  It is important to remember that BDSI growth potential is not dependent on one product and that we will continue to develop our promising product opportunities," concluded Dr. Sirgo.

Yesterday, shares of the company had risen to a high of $3.16 in anticipation of these study results, even so, shares were still trading well below (-24.44 %) their 52-week high of $4.05 with over 655,000 of the company's 29.56M in a short position.

Parties interested in the company's upcoming conference call can watch a webcast at www.bdsi.com. For those unable to access the webcast, the audio portion of the call can be accessed toll-free at (866) 516-3002 or at (760) 298-5082. For those who are not able to listen to the live broadcast, a replay of the call will be made available on the website. 



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