Nektar Therapeutics reported that partner AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Moventig (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. Moventig is an investigational, peripherally-acting mu-opioid receptor antagonist (PAMORA).

OIC is a condition caused by prescription opioid pain medicines. Opioids work by binding to mu-receptors in the central nervous system, but they also bind to mu-receptors in the gastrointestinal tract, which can result in patients suffering from OIC.

The positive opinion was reached after a review of comprehensive data from the KODIAC clinical programme, which was comprised of four studies assessing the safety and efficacy of Moventig.

The CHMP's positive opinion on Moventig will be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union. The final decision will be applicable to all 28 European Union member countries plus Iceland and Norway. Should the EC approve Moventig, it will be the first once-daily, oral PAMORA available in these markets for the treatment of OIC in adult patients who have had an inadequate response to laxatives.

This announcement follows the approval on September 16, 2014, of Moventig (naloxegol) tablets by the US Food and Drug Administration (FDA) as the first once-daily PAMORA for the treatment of OIC in adult patients with chronic non-cancer pain.

Moventig is an investigational PAMORA specifically designed for the treatment of OIC in adult patients on prescription opioid pain medicines. In phase III clinical studies, Moventig was administered as a once-daily tablet and was designed to block the binding of opioids to opioid receptors in tissues such as the gastrointestinal (GI) tract.

The KODIAC clinical programme was comprised of KODIAC-4, -5, -7 and -8. KODIAC-4 and -5 were identically-designed, placebo-controlled, double-blind, 12-week studies assessing safety and efficacy. KODIAC-7 was a 12-week safety extension to KODIAC-4, and KODIAC-8 was a 52-week long-term safety study.  

Moventig is part of the exclusive worldwide licence agreement announced on September 21, 2009, between AstraZeneca and Nektar Therapeutics. Moventig was developed using Nektar's oral small molecule polymer conjugate technology.


Nektar Therapeutics has a robust R&D pipeline of potentially high-value therapeutics in pain, oncology, haemophilia and other therapeutic areas.