Articles from Tris Pharma, Inc.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced data from cebranopadol, the company’s investigational dual-NMR agonist for the treatment of moderate-to-severe pain, featured in three poster presentations during the 50th Annual Regional Anesthesiology and Acute Pain Medicine Meeting (ASRA), taking place May 1-3, 2025, in Orlando, Florida.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced that the company will have multiple presentations during the upcoming American Academy of Pain Medicine (AAPM) 2025 PainConnect annual meeting, taking place April 3-6, 2025, in Austin, Texas.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive topline results from its ALLEVIATE-2 Phase 3 pivotal clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following bunionectomy surgery. The company also detailed additional positive data from the ALLEVIATE-1 Phase 3 pivotal clinical trial in patients following abdominoplasty surgery from which topline data were recently announced.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive clinical data from its intranasal human abuse potential (HAP) study in subjects who are nondependent recreational opioid users, which demonstrate that cebranopadol, an investigational, first-in-class oral dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist being developed for the treatment of moderate-to-severe pain, is significantly less likeable when crushed and taken intranasally (i.e., snorted) than oxycodone.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company, today announced positive topline results from its ALLEVIATE-1 pivotal Phase 3 clinical trial evaluating cebranopadol, an investigational therapy, for the treatment of moderate-to-severe acute pain in patients following abdominoplasty surgery. These results add to the growing body of data underscoring the promising efficacy and safety profile of cebranopadol, a first-in-class pain therapy involving dual-nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonism. This dual-NMR agonist has the potential to deliver significant pain relief comparable to opioids with minimized risk of significant side effects, dependence and addiction by leveraging the body’s pain biology modulation processes, synergizing the analgesic and safety characteristics of the NOP receptor with the analgesic advantages of the MOP receptor.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced additional ex-US regulatory approvals of Quillivant® XR (methylphenidate HCl extended-release oral suspension) and QuilliChew® ER (methylphenidate HCl extended-release chewable tablets) for the treatment of ADHD.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the commercial availability of ONYDA™ XR (clonidine hydrochloride) extended-release oral suspension. The U.S. Food and Drug Administration (FDA) approved the once-a-day liquid medication with nighttime dosing in May 2024 for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the promotion of Manesh Naidu, MBA, to chief commercial officer. Mr. Naidu previously served as the Company’s vice president of marketing.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced that data from a clinical study of cebranopadol suggest the investigational pain therapy produces potent and prolonged analgesia with 25% less respiratory depression than oxycodone. Cebranopadol is the company’s first-in-class dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist designed to treat multiple types of pain. The findings will be shared in a poster presentation on September 4, 2024, at the 2024 PAINWeek conference in Las Vegas.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced today the initiation of ALLEVIATE-1 and ALLEVIATE-2, pivotal Phase 3 trials evaluating the efficacy and safety of cebranopadol for the treatment of moderate-to-severe acute pain. Cebranopadol is a first-in-class investigational new therapy, with a novel mechanism of action that targets both the nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor, called dual-NMR agonist for the treatment of multiple types of pain.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced new clinical data demonstrating that cebranopadol, a dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor (dual-NMR) agonist, produces significantly less respiratory depression than oxycodone. The findings will be highlighted in a poster session on August 7, 2024, at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam.

Cranbury Pharmaceuticals (Cranbury), a wholly-owned subsidiary of Tris Pharma, today announced the U.S. Food and Drug Administration (FDA) approved the Abbreviated New Drug Application (ANDA) for the first generic version of Emflaza® oral suspension (deflazacort) for the treatment of Duchenne muscular dystrophy (DMD). The generic deflazacort oral suspension is now available to patients in the United States.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the U.S. Food and Drug Administration (FDA) has approved ONYDA™ XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in pediatric patients six years and older.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, has entered into a licensing agreement with Braingaze Ltd. (Braingaze) and launched its new business, Tris Digital Health, which will focus on the development and commercialization of digital diagnostic and therapeutic products for neurological health conditions.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the appointment of Michael Magee as vice president, quality and compliance.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced a new partnership with Perigon Pharmacy 360, a full-service, specialty digital pharmacy, to enhance accessibility, affordability and adherence for patients treating symptoms of ADHD with Tris’ DYANAVEL® XR (amphetamine) extended-release tablets.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain, addiction and neurological disorders, today announced that Health Canada has authorized the use of Quillivant® ER (extended release) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 to 12. Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively). Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced new data from a human abuse potential (HAP) study of cebranopadol (TRN-228) which suggest the investigational compound has significantly lower abuse potential compared to both schedule II and schedule IV opioids. The findings will be shared on Thursday, September 7, in a poster presentation at the 2023 PAINWeek conference in Las Vegas.

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced that the company has been awarded a grant expected to provide up to $16.6M over five years from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH). Through the Helping to End Addiction Long-term® Initiative (NIH HEAL Initiative®), NIH has awarded grants to fund the optimization of new therapies to prevent and treat opioid use disorder (OUD).

Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological disorders, today announced the appointments of Thomas Englese as chief commercial officer and Marc Lesnick, Ph.D., as chief development officer.