Nektar Therapeutics (NASDAQ: NKTR) reported that partner AstraZeneca announced today that MOVANTIK™ (naloxegol) has launched in the United States. On September 16, 2014, the US Food and Drug Administration (FDA) approved MOVANTIK as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.
"At AstraZeneca, patients are at the core of what we do every day, and it's this focus that drives us to bring first-in-class oral medicines like MOVANTIK to the market," said Dave Fredrickson, Vice President, Specialty Care, AstraZeneca. "We know many patients taking opioids for chronic non-cancer pain often experience OIC, and we believe MOVANTIK is an important treatment option for those unable to effectively manage their symptoms."
Opioids work by binding to mu-receptors in the brain and other parts of the central nervous system (CNS), but they also bind to mu-receptors in the bowel, which may cause OIC. OIC is one of the most common side effects of opioids and typically persists for the duration of treatment.
The FDA approval of MOVANTIK was based on data from the KODIAC clinical program.
In the KODIAC04 and KODIAC05 trials, response rates at 12 weeks were significantly higher with MOVANTIK 25 mg compared with placebo. The most common adverse reactions with MOVANTIK were abdominal pain, diarrhea, nausea, flatulence, vomiting, headache, and hyperhidrosis.
"MOVANTIK provides an oral treatment option that's specifically designed for patients struggling with opioid-induced constipation. When administered at recommended dose levels, MOVANTIK decreases the constipating effect of opioids by blocking opioids from binding to mu-receptors in the bowel," said Cathy Datto, US Medical Lead at AstraZeneca. "And because of its design, at recommended doses, the central nervous system penetration of MOVANTIK is expected to be negligible, limiting the potential for interference with opioid pain relief."
On March 19, 2015, AstraZeneca announced a co-commercialization agreement with Daiichi Sankyo, Inc. for MOVANTIK in the US, in line with the Company's strategy of delivering value through its own development and commercial capabilities, as well as through external collaboration. The Daiichi Sankyo sales force will join AstraZeneca in the promotion of MOVANTIK in the US by May 2015. AstraZeneca will be responsible for manufacturing, will book all sales and will make sales-related commission payments to Daiichi Sankyo, Inc.