WILMINGTON, Del. — Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.
The phase-3 trial will investigate the safety and efficacy of NKTR-118 as a treatment for opioid-induced constipation. It will consist of two 12-week placebo-controlled studies with about 630 patients each, and a long-term safety study that will include patients from the efficacy studies, as well as new patients. AstraZeneca is developing the drug under a license agreement with Nektar Therapeutics.
“This is a key milestone for NKTR-118,” AstraZeneca EVP global medicines development Anders Ekblom said. “We will put our knowledge and our effort into studying NKTR-118 as a potential new treatment option for opioid-induced constipation, which continues to be an area of unmet need in patients needing effective pain treatment.”