Higher bioavailability BNX sublingual tablets — Competitive Intelligence Brief

Higher bioavailability BNX sublingual tablets (Higher bioavailability BNX sublingual tablets) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid partial agonist. Area: Pain management; Opioid use disorder.

marketed Opioid partial agonist Mu-opioid receptor (μ-OR) Pain management; Opioid use disorder Small molecule

Target snapshot

Higher bioavailability BNX sublingual tablets (Higher bioavailability BNX sublingual tablets) — Orexo AB. BNX is a buprenorphine formulation designed to provide higher bioavailability through sublingual administration, enhancing opioid receptor partial agonism for pain and opioid use disorder treatment.

Comparator set (5 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Higher bioavailability BNX sublingual tablets TARGET	Higher bioavailability BNX sublingual tablets	Orexo AB	marketed	Opioid partial agonist	Mu-opioid receptor (μ-OR)
Sublingual buprenorphine-naloxone	Sublingual buprenorphine-naloxone	Yih-Ing Hser	phase 3	Opioid partial agonist	Opioid receptors
Standard Buprenorphine Dose	Standard Buprenorphine Dose	Rutgers, The State University of New Jersey	phase 3	Opioid partial agonist	mu-opioid receptor
Placebo First, then ORADUR®	Placebo First, then ORADUR®	Orient Pharma Co., Ltd.	phase 3	Opioid partial agonist	Opioid receptors
Pregabalin plus BBCET	Pregabalin plus BBCET	University of Maryland, Baltimore	phase 3	Anticonvulsant, Analgesic, Antidepressant, Opioid partial agonist	Voltage-gated calcium channels, Opioid receptors, Dopamine transporter, Norepinephrine transporter
pre-implementation baseline including opioid	pre-implementation baseline including opioid	Brigham and Women's Hospital	phase 3	Opioid partial agonist	mu-opioid receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Opioid partial agonist class)

1. Brigham and Women's Hospital · 1 drug in this class
2. Orexo AB · 1 drug in this class
3. Orient Pharma Co., Ltd. · 1 drug in this class
4. Rutgers, The State University of New Jersey · 1 drug in this class
5. Yih-Ing Hser · 1 drug in this class