Clinical Trials
22
0 active
Approvals
51
Total approvals
Agencies
1
Regulatory bodies
Founded
2000
Completed
21
95.5%
Terminated
1
4.5%
- Tris Pharma has launched Adneuris Therapeutics, a wholly owned subsidiary dedicated to developing and commercializing cebranopadol, an investigational first-in-class dual NOP/MOP receptor agonist for pain management. - Cebranopadol has completed two pivotal Phase 3 trials, ALLEVIATE-1 and ALLEVIATE-2, demonstrating significant pain reduction versus placebo over 48 hours and reduced opioid rescue medication use. - The dual-NMR agonist mechanism is designed to provide robust analgesia with a differentiated safety profile, potentially reducing risks of dependence, misuse, and addiction compared to conventional opioids like oxycodone. - Adneuris anticipates submitting a New Drug Application for cebranopadol in moderate-to-severe acute pain, with the FDA having already granted Fast Track Designation for chronic low back pain.
- The FDA approved Vertex Pharmaceuticals' Journavx (suzetrigine), the first new class of pain medicine approved in more than 20 years, targeting moderate-to-severe acute pain in adults. - Journavx works by blocking NaV1.8 voltage-gated sodium channels in peripheral nerves to prevent pain signals from reaching the brain, offering a non-addictive alternative to opioids. - Clinical trials in abdominoplasty and bunionectomy patients demonstrated significant pain reduction compared to placebo, with common side effects including itching, muscle spasms, and rash. - The approval addresses a critical unmet need in pain management, as 98% of globally approved pain drugs are generics and the market lacks diversity beyond NSAIDs and opioids.
- The FDA has accepted Tris Pharma's New Drug Application for TRN-257, a controlled-release, low-sodium oxybate product for treating narcolepsy and idiopathic hypersomnia in adults. - TRN-257 represents the lowest sodium oxybate treatment currently in development, containing only 80 mg sodium per 9g dose with once-nightly dosing. - The drug combines Tris Pharma's proprietary RaftWorks and LiquiXR technologies to eliminate the need for disruptive twice-nightly dosing while reducing cardiovascular risks. - The FDA has set a PDUFA goal date of June 20, 2026, for regulatory review of this potentially practice-changing sleep disorder treatment.
- Health Canada has approved Dyanavel XR, an extended-release amphetamine formulation available as both tablets and oral suspension, for treating ADHD in adults 18 years and older and children aged 6-12 years. - The medication utilizes novel LiquiXR extended-release delivery technology and represents the first and only extended-release oral suspension and chewable tablet amphetamine approved in Canada. - Dyanavel XR demonstrates significant onset of action at one hour post-dose with a 13-hour duration of therapy, addressing the needs of ADHD patients who affect approximately 3-5% of adults and 5-9% of children and adolescents. - The approval expands Kye Pharmaceuticals' ADHD portfolio in Canada, providing healthcare professionals with additional treatment options for optimizing ADHD management in both pediatric and adult populations.
- Tris Pharma's Onyda XR (clonidine hydrochloride), the first liquid, non-stimulant medication for ADHD, is now available in the U.S. for pediatric patients aged 6 and older. - Approved by the FDA in May 2024, Onyda XR can be used as a monotherapy or as an adjunctive therapy with CNS stimulants for ADHD treatment. - Clinical trials supporting approval included placebo-controlled studies demonstrating efficacy and safety in pediatric patients, with common adverse reactions including somnolence and fatigue. - Onyda XR offers a new treatment option for ADHD patients who struggle with pills or need longer-acting therapy, addressing a significant unmet need in ADHD management.
- Tris Pharma's cebranopadol significantly reduced pain intensity in patients following abdominoplasty in the ALLEVIATE-1 Phase 3 trial. - The investigational dual-NMR agonist demonstrated a favorable safety profile, comparable to placebo, with nausea being the most common adverse event. - Cebranopadol targets both nociceptin/orphanin FQ peptide (NOP) and μ-opioid peptide (MOP) receptors, offering a novel approach to pain relief. - Tris Pharma plans to submit a New Drug Application (NDA) for cebranopadol later this year, with further studies in chronic pain indications planned.
