![]() – Treatments studied included single doses of: BELBUCA (300 mcg, 600 mcg, and 900 mcg) oral oxycodone hydrochloride (Oxy 30 mg and 60 mg) and placebo (each separated by a 7-day washout period). ![]() – Effect on respiratory drive was assessed using a double-blind, double-dummy, 6-treatment, 6-period, placebo controlled, randomized crossover design. – Study subjects (N = 19) were healthy males and females self-identifying as recreational drug users and determined via naloxone challenge to not be physically dependent on opioids. In this clinical trial, BDSI evaluated the effect of BELBUCA® (buprenorphine buccal film), a Schedule III opioid, and oral oxycodone HCI, a Schedule II opioid, on respiratory drive. Respiratory depression is a breathing disorder characterized by slow and ineffective breathing and is the leading cause of opioid related deaths. ![]() Opioids can cause serious, life-threatening, or fatal respiratory depression. In May 2019, in response to significant challenges chronic pain patients face in obtaining adequate care and the ongoing opioid crisis, The Pain Management Best Practices Inter-Agency Task Force report recommended more research activities directed to better understanding the use of buprenorphine, a Schedule III opioid. 27, 2020 (GLOBE NEWSWIRE) - BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today presented at the American Academy of Pain Medicine’s (AAPM) 36th Annual Meeting the results of a study titled, “A Phase I Placebo-Controlled Trial Comparing the Effect of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride on Respiratory Drive”. Immediate Release Oral Oxycodone HCl Associated with a Dose-Dependent Decrease in Respiratory Drive Compared to Placebo BioDelivery Sciences Announces Phase I Clinical Trial Results at the American Academy of Pain Medicine’s 36th Annual MeetingīELBUCA® Effect on Respiratory Drive was Comparable to Placebo in Clinical Trial at all Tested Doses
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