Salix Pharmaceuticals Announces a Phase 2 Investigator-Initiated Study of RELISTOR(R) (methylnaltrexone bromide: MNTX) in Patients with Resectable Head and Neck Squamous Cell Carcinoma

LAVAL, QC / ACCESSWIRE / March 6, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced that it is supporting a Phase 2 investigator-initiated study (IIS) of RELISTOR (methylnaltrexone bromide: MNTX) in patients with resectable head and neck squamous cell carcinoma. An IIS is a study that is proposed, developed, and conducted by a qualified sponsor external to Bausch Health/Salix who assumes full responsibility for the study.

The clinical study is being led by Juan P. Cata, M.D. at The University of Texas MD Anderson Cancer Center. The trial is designed to evaluate the potential of treating oral cavity squamous cell carcinoma patients with MNTX. It is a prospective, nonrandomized pilot "proof of concept" study where patients receive subcutaneous MNTX two weeks preoperatively and two weeks postoperatively.

"The preclinical data and clinical suggestions point to potential activity against cancer," Robert Israel, M.D., Senior Vice President, Clinical and Medical Affairs, said. "Having Dr. Cata study this drug in head and neck cancer will shed light on how and if this agent could be further developed as a potential treatment option in neoplastic disease."

Upon completion of the study, participants will be monitored every 3 months during the first two years. The primary endpoint is the successful administration of MNTX for two weeks preoperatively and postoperatively without interruption due to adverse events. Secondary endpoints include tumor viability, proliferation and apoptosis index, objective response rate, survival rates, and patient-reported outcomes. https://clinicaltrials.gov/ Identifier: NCT06162377.

About RELISTOR

RELISTOR (methylnaltrexone bromide) is an opioid antagonist. RELISTOR tablets and RELISTOR injection are indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

RELISTOR injection is also indicated for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

IMPORTANT SAFETY INFORMATION

RELISTOR tablets and injection are contraindicated in patients with known or suspected mechanical gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.