Phase 2 Study of RELISTOR for Treatable Head and Neck Cancer

Bausch Health Companies Inc., along with its gastroenterology division Salix Pharmaceuticals, has announced support for a Phase 2 study of RELISTOR® (methylnaltrexone bromide) in patients with head and neck squamous cell carcinoma. The research is being conducted by Dr. Juan P. Cata at The University of Texas MD Anderson Cancer Center. This study is a prospective pilot study where patients receive subcutaneous MNTX both before and after surgery.

The Senior Vice President of Clinical and Medical Affairs, Robert Israel, M.D., has expressed optimism about the drug's potential against cancer based on preclinical data and clinical indications. The study's primary goal is to administer MNTX without interruption due to adverse events, with secondary goals including the assessment of tumor viability, response rates, survival rates, and patient-reported outcomes.

RELISTOR is an opioid antagonist used to treat opioid-induced constipation in adults with chronic non-cancer pain. It is also used for treating constipation in adults with advanced illness or active cancer requiring increased opioid dosage for palliative care. However, it is contraindicated in patients with a known or suspected mechanical gastrointestinal obstruction due to the risk of gastrointestinal perforation.

The drug has been associated with cases of gastrointestinal perforation in patients with conditions that may weaken the gastrointestinal tract wall. Symptoms of severe or worsening abdominal pain should prompt discontinuation of RELISTOR. Additionally, patients treated with RELISTOR may experience symptoms consistent with opioid withdrawal, and caution is advised for those with disruptions to the blood-brain barrier.

Concurrent use of RELISTOR with other opioid antagonists is not recommended due to the potential for increased opioid withdrawal risk. The drug's use during pregnancy may induce opioid withdrawal in the fetus, and breastfeeding is not recommended during treatment. Dosage adjustments are necessary for patients with renal or hepatic impairment.

Salix Pharmaceuticals is dedicated to the prevention and treatment of gastrointestinal diseases, with a focus on improving patient lives through innovative products. Bausch Health Companies Inc. is a global company committed to improving lives with health care products, with a range of pharmaceutical, medical device, and over-the-counter products in eye health, gastroenterology, and dermatology.