HOME >> BIOLOGY >> NEWS
BDSI announces positive phase III clinical trial results

MORRISVILLE, N.C.April 25, 2007 -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced today statistically significant results with BEMA Fentanyl in cancer patients with breakthrough pain in its pivotal Phase III efficacy clinical trial for the product. The results are based on achievement of the primary efficacy endpoint of the trial, Summary of Pain Intensity Difference (SPID), compared to placebo.

The results demonstrated that patients treated with BEMATM Fentanyl showed a statistically significant improvement on the primary efficacy endpoint at 30 minutes (SPID 30) compared to placebo (p<0.004), meaning a greater reduction in pain. Eighty (80) patients participated in the double-blind, placebo-controlled portion of the study.

BEMA Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. Upon administration, BEMA Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes.

Dr. Andrew Finn, BDSIs Executive Vice President of Product Development, stated "We are obviously very pleased with these efficacy results. Only five patients (approximately 3% of those patients entering the initial titration phase of the study) were unable to achieve adequate pain relief. We believe this high level of pain control is attributable to the efficient, reliable absorption from the buccal mucosa, the ease of application of the BEMA Fentanyl product and the ability to titrate across a wide range of doses up to and including our 1200 mcg dose. Importantly, the results also demonstrated that BEMA Fentanyl was well-tolerated by patients in the trial, with no reported drug-related changes to the oral mucosa, which is important for cancer patients who may also have oral ulcerations as a result of a weakened immune system."

"Once we have the remainder of the data analyzed, including the secondar
'"/>

Contact: Bill Douglass
bdouglass@investorrelationsgroup.com
212-825-3210
BioDelivery Sciences
25-Apr-2007


Page: 1 2 3 4

Related biology news :

1. Almac Diagnostics announces pioneering genetic research on ductal carcinoma in situ
2. ESA announces 2007 award recipients
3. President Bush announces 2005 and 2006 Laureates of National Medals of Science and Technology
4. Conservation Leadership Program announces 2007 awardees
5. ACMG Foundation announces 2007-2008 Luminex/ACMGF award recipient
6. Revolutionary global environment fund announces $50M expansion
7. Biovest announces interim blinded data of fast-tracked pivotal Phase 3 clinical trial of BiovaxID
8. Cell Press announces new partnership with the American Society of Human Genetics
9. ChemGenex announces publication confirming activity of Ceflatonin in T315I-Positive CML
10. Minister Lunn announces $39.6M for next phase of mountain pine beetle response
11. BioMed Central announces new interdisciplinary Biofuels Journal

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:8/26/2020)... ... August 25, 2020 , ... ... pharmaceuticals targeting mitochondria, in partnership with Essex Bio-Technology, a bio-pharmaceutical company specializing ... Phase 3 VISTA-2 study of SkQ1 ophthalmic solution in patients with moderate ...
(Date:8/26/2020)... ... 2020 , ... Modality Solutions, a biopharmaceutical cold chain validation engineering ... The list is the most prestigious ranking of the nation’s fastest-growing private companies. Modality ... list, reported three-year revenue growth of 71 percent. , The Inc. 5000 list ...
(Date:8/21/2020)... ... August 18, 2020 , ... Sentien Biotechnologies, Inc., a ... U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug ... of severe COVID-19. Approval of this IND allows Sentien to initiate a Phase ...
Breaking Biology News(10 mins):
(Date:7/31/2020)... ... July 30, 2020 , ... ... sciences industry, today announced the release of its signature product called Beacon ... Liaisons (MSLs) and other field medical professionals. , Beacon helps MSLs ...
(Date:7/18/2020)... ... July 17, 2020 , ... dicentra ... life sciences and food industries, is pleased to announce that Charles Galea has ... Business Development. , Charles is an accomplished and results-driven sales executive with over ...
(Date:7/7/2020)... ... , ... R3 International is now offering stem cell therapy for Alzheimers dementia ... on the patient's condition, treatment may be offered IV, intrathecal or with a combination. ... Alzheimers dementia, and the incidence continues to increase as individuals live longer. There is ...
(Date:6/28/2020)... ... June 25, 2020 , ... The Indoor Lab, a ... Safe Space™ for businesses of all types to ensure cleanliness, distancing and occupancy with ... , A Safe Space™ enabled business will provide a health performance index system that ...
Breaking Biology Technology:
Cached News: