Movantik™ (naloxegol) is an opioid antagonist therapy indicated for the treatment of opioid-induced constipation in adult patients with chronic, non-cancerous pain.
The drug was developed by Nektar Therapeutics using proprietary oral small molecule polymer conjugate technology. AstraZeneca in-licensed the drug under a drug development programme in September 2009.
AstraZeneca submitted a new drug application (NDA) for the drug to the US Food and Drug Administration (FDA) in September 2013, receiving approval for the same in September 2014. The company collaborated with Daiichi Sankyo for the commercialisation of the drug in the US in March 2015.
The drug was approved in the European Union (EU) under the brand name Moventig™ in December 2014. AstraZeneca collaborated with ProStrakan Group, a subsidiary of Kyowa Hakko Kirin, for the marketing of the drug in the EU, Iceland, Norway, Switzerland, and Liechtenstein in March 2016.
Movantik is a mauve-coloured, oval, biconvex, film-coated tablet for once-daily, oral administration. It is available in two strengths, 12.5mg and 25mg.
Opioid-induced constipation is the most prevalent condition associated with opioid therapy. The condition affects between 15% and 90% of patients suffering from chronic non-cancer related pain.
Millions of people are treated with opioids for pain management, as the drug helps to relieve chronic pain. When an opioid binds to the mu-opioid receptors in the gastrointestinal tract, it causes opioid-induced constipation in patients.
Some of the common symptoms of opioid-induced constipation include dry and hard stools, abdominal bloating and tenderness, difficulty in defecating, nausea and vomiting.
Movantik, containing naloxegol oxalate as an active ingredient, functions as a peripherally-acting mu-opioid receptor antagonist. It binds to the mu-opioid receptors in the tissues such as gastrointestinal tract and prevents its opioid binding, reducing the symptoms of opioid-induced constipation.
The FDA’s and European Commission’s approval of the drug came from the results of a clinical programme named KODIAC, comprising four studies KODIAC-4, 5, 7, and 8.
KODIAC-4 and 5 were 12-week, placebo-controlled, double-blind clinical studies to evaluate the safety and efficacy of the drug. KODIAC-7 was a 12-week extension study to KODIAC-4 for safety evaluation, while KODIAC-8 was a 52-week study for long-term safety evaluation.
KODIAC-4 was a phase III clinical study that enrolled 652 patients with opioid-induced constipation. The patients were randomised to receive either 12.5mg or 25mg dose of Movantik once-daily or placebo. The primary endpoint of the study was the response rate measured in patients.
An estimated 44% of patients receiving 25mg of Movantik and 41% of patients receiving 12.5mg of Movantik responded, compared to 29% of patients receiving a placebo.
In the phase III KODIAC-5 study, 700 patients were randomised to receive either 12.5mg or 25mg of Movantik or placebo for 12 weeks. A total of 40% of the patients receiving 25mg Movantik and 35% of patients receiving 12.5mg Movantik responded, compared to 29% of the patients on placebo.
In KODIAC-7 safety evaluation, the number of adverse events and serious adverse events, including major cardiovascular events was lower than those in KODIAC-4 and 5.
KODIAC-8 was a phase III clinical study that enrolled 844 patients. The patients were randomised to receive either Movantik or usual care for opioid-induced constipation patients with non-cancer related pain for 52 weeks.
The results were found to be similar to those of earlier phase III clinical studies results with no elevation in serious adverse events.
The most common adverse events observed in the patients during the clinical trials were abdominal pain, diarrhoea, nausea, flatulence, vomiting and headache.
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