Endo Pharmaceuticals and BioDelivery Sciences Present New Data on Investigational Product Buprenorphine HCl Buccal Film for Chronic Pain Management
Data demonstrate ability to convert from an opioid full agonist like morphine and oxycodone to buprenorphine HCl buccal film
Buprenorphine HCl buccal film is being developed under the proprietary name BELBUCA™ (buprenorphine HCl) buccal film and is currently under review by the
"This study demonstrated that study participants on a full agonist were successfully switched to buprenorphine HCl buccal film, an opioid partial agonist, at approximately 50 percent of the full agonist dose, without the need for an opioid taper and without increasing the risk of withdrawal or loss of pain control," said
Buprenorphine HCl buccal film provides buprenorphine in an optimally-designed delivery system, which efficiently and conveniently delivers buprenorphine across the buccal mucosa (inside lining of the cheek). Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes most opioid analgesics.
Switching from an Opioid Full to Partial Agonist
The Phase 2, randomized, double-blind, active controlled, 2-period crossover study included 39 chronic pain sufferers who were receiving 80 mg to 220 mg (80-160 mg, n=33; 161-220 mg, n=6) daily around-the-clock therapy of an opioid full agonist (either morphine sulfate or oxycodone HCl), and were confirmed to be opioid dependent. Approximately eight to 12 hours after the last full agonist dose, study subjects received buprenorphine HCl buccal film 300 or 400 mcg, which was calculated to be equivalent to 50 percent of their full agonist dose. The study also included an active-control group, who remained on 50 percent of their full agonist dose. The primary endpoint was the proportion of study participants that demonstrated significant withdrawal symptoms (a maximum Clinical Opiate Withdrawal Scale, or COWS, score of ≥13) or required rescue therapy because of these symptoms.
Of the 35 study participants [31 on 80-160 mg and 4 on 161-220 mg morphine sulfate equivalent (MSE)/day] that completed both periods of the study, significant withdrawal was experienced in one study participant on buprenorphine HCl buccal film and two participants on the full agonist treatment arm. Mean maximum COWS scores were comparable for participants in the buprenorphine HCl buccal film group versus the full agonist group [in the 80-160mg MSE dose group: Mean (SD) 4.6 (3.15) vs. 5.3 (4.42), respectively; p=0.79; in the 161-220 mg MSE dose group, 5.5 (1.91) vs. 6.3 (2.50), p=0.62]. There was no significant difference in pain ratings between the buprenorphine and full agonist treatment groups for patients in the 80-160 mg MSE dose group. The sample size for patients in the higher dose (161 to 220 mg) group was too small to permit a rigorous statistical analysis or conclusions from the data.
The COWS total scores indicate that these subjects were successfully switched between around-the-clock (ATC) opioid and buprenorphine in the dose range (80-220 mg MSE) without precipitating withdrawal issues. There was no evidence of a difference in precipitated opioid withdrawal following buprenorphine and ATC opioid administered 12 hours after a therapeutic dose of ATC opioid.
"We are excited by these new findings as they add to the growing body of evidence supporting the potential of buprenorphine HCl buccal film as an appropriate, effective pain relief option with a low incidence of typical opioid-like side effects," said
Overall, adverse events (AEs) were reported in 20 study participants (60.6 percent) in the 80-160 mg MSE group and 1 patient (16.7 percent) in the 161-220 mg dose group. For the 80-160 mg MSE group, 18 participants (56.3 percent) had at least one AE during buprenorphine HCl buccal film treatment and 13 participants (40.6 percent) had at least one AE during mu-opioid full agonist therapy. The most common AEs reported in the buprenorphine HCl buccal film group included headache (18.8 percent), vomiting (12.5 percent), and nausea, diarrhea, and drug withdrawal syndrome (9.4 percent for each). In the group continuing on the opioid full agonist (50 percent dose, opioid full agonist treatment), the most frequently reported AEs were headache (15.6 percent), drug withdrawal syndrome (12.5 percent), and nausea (6.3 percent).
"Buprenorphine HCl buccal film represents a novel approach to treating chronic pain and if approved, it will be the first and only pain medicine combining the proven efficacy and safety of buprenorphine with BDSI's unique BEMA® delivery system," said
About Buprenorphine HCl Buccal Film
Buprenorphine is a Schedule III controlled substance, meaning that it has been designated as having lower abuse potential than Schedule II drugs, a category which includes most opioid analgesics. Buprenorphine is a mu-opioid receptor partial agonist and a potent analgesic with a relatively long duration of action. Buprenorphine HCl buccal film is being developed under the proprietary name BELBUCA™ (buprenorphine HCl) buccal film and if approved, will be commercialized through a worldwide license and development agreement between
About Endo Pharmaceuticals Inc.
BDSI's headquarters is located in
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including the statements by Dr. Webster, Dr. Hall and Dr. Finn, and other statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product approval and availability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect
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Endo International plc: Investors/Media: Keri P. Mattox (484) 216-7912; Investors: Jonathan Neely (484) 216-6645; Media: Heather Zoumas-Lubeski (484) 216-6829 or BioDelivery Sciences International: Investors: Al Medwar, VP, Marketing and Corporate Development (919) 582-9050; Matthew P. Duffy, Managing Director, LifeSci Advisors, LLC, 212-915-0685