In its Phase III CB-5945 ascent study for the treatment of OIC Pipeline Drugs Market, Cubist Pharmaceuticals has begun enrolling patients.
One of four registrational studies on patients with chronic non-cancer pain is the multicentre, long-term safety study.
The placebo-controlled, double-blind, randomised (1:1) study will enroll 1,400 eligible US and Canadian patients to evaluate CB-5945 (0.25 mg twice daily).
According to Cubist Chief Scientific Officer Dr. Steve Gilman, opioid-induced constipation is a debilitating side effect for millions of people with chronic non-cancer pain.
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According to Gilman, "We are excited to begin the robust Phase III development program for CB-5945 and hope to one day make this important therapy available to patients."
The primary objective of the study is to compare the safety of CB-5945 (0.25% twice daily) to placebo over a one-year treatment period. The secondary objective is to compare the candidate's effects on quality of life.
The Phase III program is expected to enroll nearly 3,200 patients in total.
CB-5945 is a potent mu opioid receptor antagonist that works peripherally to prevent opioid analgesics from affecting the gastrointestinal tract's side effects while maintaining centrally mediated pain relief.