FDA OKs Opioid-Induced Constipation Drug By Nektar And AZ
AstraZeneca, together with its partner Nektar Therapeutics, announced that the U.S. Food and Drug Administration (FDA) has given the green light to Movantik (naloxegol), an oral drug for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Movantik is a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) marketed in tablet form. The drug was developed using Nektar’s oral small molecule polymer conjugate technology and licensed for distribution by AstraZeneca in 2009.
The drug addresses a common side effect of opioid painkillers that decreases the gastrointestinal tract’s motility. OIC drugs, such as Movantik, are designed to neutralize the effects of opioid painkillers in the gut without negatively affecting centrally mediated pain relief. The FDA approved Movantik based on positive data from the KODIAC trials showing that more patients treated with naloxegol experienced an increase in bowel movements on a weekly basis compared to placebo.
Dr. Briggs Morrison, EVP of Global Medicines Development & CMO of AstraZeneca, said that the company is pleased with the approval. “The FDA approval of Movantik provides a new treatment option for adult patients with chronic non-cancer pain suffering from opioid-induced constipation, a common side effect of opioid therapy.”
“Supportive care products such as Movantik can lessen the constipating side effects of opioids,” commented Julie Beitz, director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.
While the drug will enjoy a two to three years’ advantage over other investigational OIC drugs, including Salix and Progenics’ Relistor, AZ and Nektar must conduct a postmarketing study to monitor Movantik’s potential risk of heart-related side effects as per request of the FDA. Should the FDA require the cardiovascular safety study before its approval, Nektar would have had to fork over the $70 million it received last year from AstraZeneca as part of their agreement. Nektar will pocket $30 million with the FDA approval and will get another $100 million once its British partner starts marketing Movantik.
Nektar CEO Howard Robin said that the company is delighted with the validation of its technology and the future it promises for the firm. Robin says, “The goal is to become cash-flow positive — I can't predict when that will be. But with Movantik, we have the opportunity to be cash-flow positive and make investments in our pipeline.”