LAVAL, QC - Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its subsidiary Salix Pharmaceuticals announced today their support for a Phase 2 investigator-initiated study of RELISTOR® in patients with a specific type of cancer. The study, led by Dr. Juan P. Cata at The University of Texas MD Anderson Cancer Center, aims to explore the drug's potential in treating resectable head and neck squamous cell carcinoma.
RELISTOR®, known generically as methylnaltrexone bromide, is traditionally used to treat opioid-induced constipation in adults with chronic non-cancer pain and for those with advanced illness or pain caused by active cancer requiring opioid dosage escalation for palliative care. This new study will investigate the drug's application as a preoperative and postoperative treatment for oral cavity squamous cell carcinoma.
Patients in the trial will receive subcutaneous injections of the drug two weeks before and after surgery. The study's primary goal is to administer RELISTOR® without interruption due to adverse events. Secondary objectives include assessing tumor viability, proliferation and apoptosis index, response rate, survival rates, and patient-reported outcomes.
Dr. Robert Israel, Senior Vice President of Clinical and Medical Affairs at Salix, expressed that preclinical data suggest potential anti-cancer activity, and the study led by Dr. Cata will provide insights into the drug's viability as a cancer treatment.
The safety profile of RELISTOR® includes contraindications for patients with gastrointestinal obstruction or those at risk of recurrent obstruction. Reported side effects in clinical studies include abdominal pain, diarrhea, and symptoms consistent with opioid withdrawal.
Salix Pharmaceuticals, a specialty pharmaceutical company, focuses on the prevention and treatment of gastrointestinal diseases and markets its products to U.S. healthcare providers. Bausch Health, the parent company, is a global firm dedicated to advancing health through a range of pharmaceutical, medical device, and over-the-counter products.
This announcement is based on a press release statement and provides a factual account of the company's support for the study without endorsing the claims. The study's results and potential implications for RELISTOR® as a cancer treatment remain to be evaluated upon completion of the trial.
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