Sucampo Pharmaceuticals (SPI) and Takeda Pharmaceuticals have announced the results from the Phase 3 clinical trial of Lubiprostone as a treatment of opioid-induced bowel dysfunction (OBD) in patients with chronic, non-cancer pain, excluding those taking methadone.
The randomised placebo-controlled double-blinded trial enrolled a total of 439 patients in the US and Europe to evaluate the efficacy and safety of Lubiprostone in patients with OBD.
In the study, patients were evenly randomised to receive either placebo or lubiprostone 24-mcg gel capsule twice daily throughout the 12-week treatment period and found that the response rate for Lubiprostone-treated patients was 26.9%, compared to 18.6% for placebo-treated patients.
The study participants are defined to have an average of fewer than three SBMs per week during the three-week screening period and at least one of the following for at least 25% of SBMs during each week of the screening period.
The primary endpoint of the trial is the overall spontaneous bowel movement (SBM) response rate which is determined based on patients' daily record of bowel movements.
Trial investigator Mazen Jamal said the Phase 3 trial data showed that Lubiprostone has the potential to be the first the US Food and Drug Administration approved orally administered medicine with the indication to treat OBD in non-cancer, non-methadone patients.
SPI chairman and CEO, Ryuji Ueno, said: "The findings from the study confirm the previous Phase 3 trial results of Lubiprostone in OBD patients and together with data from the associated long-term safety trial."
Ueno added: ''We expect to submit the supplemental new drug application (sNDA) to the FDA in the first half of 2012.''
Sucampo Pharmaceuticals is an international biopharmaceutical company focused on the discovery, development and commercialisation of medicines based on prostones, which occur naturally in the human body as a result of enzymatic (15-PGDH) transformation of certain fatty acids.
OBD characterises a range of adverse gastrointestinal effects which includes severe constipation, infrequent or incomplete bowel movements, hard stool consistency, straining associated with bowel movements, and abdominal discomfort, pain and bloating.