Shares of BioDelivery Sciences International, Inc. (BDSI) jumped 8.92% after the company along with its partner Endo Pharmaceuticals Inc., a subsidiary of Endo International (ENDP), announced positive top-line results from a pivotal phase III efficacy study evaluating their pain candidate, BEMA buprenorphine, in opioid-experienced patients.
The double-blind, randomized, withdrawal phase III study evaluated the efficacy and safety of BEMA buprenorphine in opioid-experienced patients suffering from chronic lower back pain. The study met its primary efficacy endpoint. Results showed that the use of BEMA buprenorphine resulted in a significant improvement in chronic pain relief compared to placebo. BioDelivery and Endo plan to meet with the FDA this month and submit a regulatory application at the earliest.
The companies are developing BEMA buprenorphine for pain management in both opioid naïve and opioid experienced patients suffering from severe pain and requiring daily, around-the-clock, long-term opioid treatment.
Earlier this year, BioDelivery and Endo had announced positive top-line results from a phase III study evaluating the use of BEMA buprenorphine in opioid-naïve patients. The study met its primary efficacy endpoint and BEMA buprenorphine demonstrated significant improvement in chronic pain relief compared to placebo.
Our Take
We are positive on the encouraging data from the pivotal phase III efficacy study. Positive data in both opioid naïve and opioid experienced patient populations have enhanced the candidate’s chances of gaining regulatory approval. Meanwhile, BioDelivery stands to receive a $10 million milestone payment from Endo due to the locking of the database for the opioid-experienced study.
BioDelivery Sciences has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering include Biogen Idec Inc. (BIIB) and The Medicines Company (MDCO). Both stocks carry a Zacks Rank #1 (Strong Buy).
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