Poster Number-20 - Cebranopadol, a Novel Potent Analgesic: Review of Clinical Studies Conducted Across Multiple Types of Pain including Chronic Lower Back Bain, Acute Pain, Diabetic Peripheral Neuropathy, and Cancer Pain

Cebranopadol, a Novel Potent Analgesic: Review of Clinical Studies Conducted Across Multiple Types of Pain including Chronic Lower Back Bain, Acute Pain, Diabetic Peripheral Neuropathy, and Cancer Pain

Purpose:

Cebranopadol is a novel, highly potent analgesic with high affinity for nociceptin/orphanin FQ peptide (NOP) and opioid receptors. It is highly effective in animal models of acute pain, visceral, inflammatory, chronic mono-and poly-neuropathic, and bone cancer pain.

In order to understand its clinical efficacy in humans, seven Phase 2 and one Phase 3 trials were conducted across multiple types of pain including chronic pain due to osteoarthritis, acute pain following bunionectomy, diabetic peripheral neuropathy, chronic lower back pain, and cancer pain.

Methods: A descriptive analysis utilized trial data from 8 pain trials conducted with cebranopadol: 2 osteoarthritis pain, 1 acute pain (bunionectomy), 3 diabetic peripheral neuropathy (DPN), 1 chronic lower back pain (cLBP), and 1 chronic cancer pain trial. Across the 8 trials, patients were randomized to receive 25-1000μg/day of cebranopadol by mouth or a control including, placebo, morphine sulfate sustained release (SR), tapentadol prolonged release (PR), morphine sulfate PR, pregabalin, or oxycodone controlled release (CR), for a duration of 2 days to 15 weeks.

Results:

Analysis included study design, sample size, basic patient demographics, dosing of cebranopadol and comparator agents and outcome measures including efficacy and safety.

Conclusion: Cebranopadol has demonstrated efficacy across a variety of pain types, and when considered along with safety and abuse potential data may serve as a much-needed treatment option for patients with moderate to severe pain.  

References: • Christoph A, Eerdekens MH, Kok M, Volkers G, Freynhagen R. Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial. Pain. 2017;158(9):1813-1824.
• Bothmer J, Scholz A, Höschen K, Daniels S. Cebranopadol, A Novel First-in-Class Analgesic: Results From a Study in Patients With Moderate to Severe Pain Following Bunionectomy. Presented at PAINWeek 2016; September 6-10, 2016; Las Vegas, NV.
• Eerdekens MH, Dietlind Koch E, Kok, M, Sohns M, Forst T. Cebranopadol, A Novel First-in-Class Analgesic: Efficacy, Safety, Tolerability in Patients With Pain Due to Diabetic Peripheral Neuropathy (DPN). Presented at PAINWeek 2016; September 6-10, 2016; Las Vegas, NV.
• Eerdekens MH, Kapanadze S, Dietlind Koch E, Kralidis G, Volkers G, Meißner W. Cebranopadol, A Novel First-in-Class Analgesic: Efficacy, Safety, Tolerability in Patients With Cancer Related Chronic Pain. Presented at the International Association for the Study of Pain 2016 World Congress on Pain. September 26-30, 2016; Yokohama, Japan.
• Toll L, Bruchas MR, Calo' G, Cox BM, Zaveri NT. Nociceptin/Orphanin FQ Receptor Structure, Signaling, Ligands, Functions, and Interactions with Opioid Systems. Pharmacol Rev. 2016;68(2):419-457.
• Data on file. Tris Pharma, Inc. IB12ed.