Buvaya

Buvaya (buprenorphine sublingual spray) is a small molecule opioid analgesic developed by INSYS Therapeutics for the management of moderate-to-severe acute postoperative pain. The drug is formulated as a sublingual spray to provide rapid absorption and onset of action. Buprenorphine, the active ingredient, acts as a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor, a profile intended to provide effective analgesia with a potentially lower risk of respiratory depression compared to full mu-opioid agonists. Despite meeting its primary endpoint in a Phase 3 clinical trial for postoperative pain following bunionectomy, the FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 18-1 against its approval in May 2018. The committee cited concerns over a narrow therapeutic window, modest efficacy, and a high incidence of adverse events, including nausea, vomiting, and hypoxia. Following the negative advisory vote and the subsequent bankruptcy of INSYS Therapeutics, development of the drug was terminated.

Brand names

Buvaya

Other names

buprenorphine sublingual sprayINSYS buprenorphine