Omnitram (desmetramadol) / Syntrix - LARVOL DELTA

A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Syntrix Biosystems, Inc.; Recruiting ➔ Completed

Clinical • Trial completion • Pain

A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Syntrix Biosystems, Inc.

Clinical • New P1 trial • Pain

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy (clinicaltrials.gov) - P2; N=55; Completed; Sponsor: Syntrix Biosystems, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Desmetramadol has the Safety and Analgesic Profile of Tramadol Without Its Metabolic Liabilities: Consecutive Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trials. (PubMed, J Pain) - P1, P1b | "We conducted consecutive double-blind, randomized, placebo-controlled, 3 segment cross-over trials A and B to investigate the steady-state pharmacokinetics and analgesia of 20 mg desmetramadol and 50 mg tramadol in 103 healthy participants without (n = 43) and with (n = 60) cotreatment with the CYP inhibitor paroxetine. CLINICALTRIALS.GOV REGISTRATIONS: NCT02205554, NCT03312777 PERSPECTIVE: To our knowledge, this is the first study of desmetramadol in humans and the first to show it provides the same safety and analgesia as tramadol, but without tramadol's metabolic liabilities and related drug-drug interactions. Desmetramadol could potentially offer expanded safety and utility to clinicians seeking an alternative to schedule II opioids."

Clinical • Journal • Pain

Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers (clinicaltrials.gov) - P1b; N=60; Active, not recruiting; Sponsor: Syntrix Biosystems, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Biosimilar • Pain

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy (clinicaltrials.gov) - P2; N=55; Active, not recruiting; Sponsor: Syntrix Biosystems, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Diabetic Neuropathy • Gene Therapies • Neuralgia • Pain

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Syntrix Biosystems, Inc.; Trial completion date: Mar 2020 ➔ Sep 2020; Trial primary completion date: Feb 2020 ➔ Jun 2020

Clinical • Trial completion date • Trial primary completion date

Desmetramadol Is Identified as a G-Protein Biased µ Opioid Receptor Agonist. (PubMed, Front Pharmacol) - "It is unknown why tramadol spares respiration. Here we show its active metabolite, desmetramadol, is as effective as morphine, oxycodone and fentanyl in eliciting G protein coupling at the human µ opioid receptor (MOR), but surprisingly, supratherapeutic concentrations spare human MOR-mediated βarrestin2 recruitment thought to mediate lethal opioid-induced respiratory depression."

Journal

Syntrix discovers desmetramadol is G-protein biased opioid receptor agonist (PRNewswire) - "Syntrix Pharmaceuticals announces the discovery that desmetramadol...The results, published in Frontiers in Pharmacology show that desmetramadol, the active metabolite of tramadol, is as effective as morphine, oxycodone and fentanyl in eliciting G protein coupling at the human μ opioid receptor (MOR) involved in pain relief, but surprisingly, supra-therapeutic concentrations typical of overdose spare human MOR-mediated barrestin2 recruitment, the signaling pathway of the receptor thought to mediate lethal opioid-induced respiratory depression."

Preclinical

Syntrix Pharmaceuticals to present positive desmetramadol trial results at the 2019 Pain Management SUMMIT (PRNewswire) - "Syntrix Pharmaceuticals, Inc....today announced that Syntrix's President and CEO, John Zebala, MD, PhD, will present an overview of desmetramadol and positive first-in-man trial results at the 2019 Pain Management SUMMIT. The presentation will take place on Wednesday, November 20th at 10:00 AM EST at The Inn at Penn in Philadelphia."

Clinical data

Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy (clinicaltrials.gov) - P2; N=50; Recruiting; Sponsor: Syntrix Biosystems, Inc.; Trial completion date: Jul 2019 ➔ Mar 2020; Trial primary completion date: Jul 2019 ➔ Feb 2020

Clinical • Trial completion date • Trial primary completion date