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SAN FRANCISCO , June 12, 2014 /PRNewswire/ -- Nektar Therapeutics (NASDAQ: NKTR ) reported today that partner AstraZeneca announced that the majority of US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) members voted that the FDA should not require cardiovascular outcomes trials for the peripherally-acting mu-opioid receptor antagonist (PAMORA) class of drugs, which includes MOVANTIK TM (naloxegol oxalate), an investigational treatment for opioid-induced constipation (OIC) for patients with chronic non-cancer pain. Following a clarification of the vote, the majority of the Committee suggested continued post-approval data collection for cardiovascular safety.
The FDA convened a meeting of the AADPAC to review the class of peripherally acting opioid receptor antagonists on June 11-12, 2014 . The meeting assessed the necessity, timing, design and size of cardiovascular outcomes trials to support approval of products in the class, for the proposed indication of OIC in patients taking opioids for chronic non-cancer pain. The FDA is not bound by the Advisory Committee's recommendation, but takes its advice into consideration when reviewing applications for investigational medicines. The Prescription Drug User Fee Act (PDUFA) date set by the FDA for MOVANTIK is September 16, 2014 .
"We are exceptionally pleased that the Committee did not find it necessary to require a cardiovascular outcomes trial," said Howard W. Robin , President and CEO of Nektar Therapeutics. "We look forward to the FDA's continued review of the New Drug Application for MOVANTIK and the potential for MOVANTIK to become the first once-daily, oral PAMORA for the treatment of OIC for patients with chronic non-cancer pain."
MOVANTIK was designed using Nektar's proprietary oral, small molecule polymer conjugate technology. MOVANTIK is part of the exclusive worldwide licence agreement announced in September 2009 between AstraZeneca and Nektar.
Opioids play an important role in chronic pain relief by binding mu-receptors in the brain, but they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop OIC. In fact, the incidence of OIC can be as high as 81% in patients taking opioids. There is a significant unmet need for safe, effective treatment options for patients with OIC. An estimated 235 million prescriptions for opioids are written in the US each year, of which 20% are for chronic pain. For patients taking prescription opioids for chronic pain, constipation is one of the most common side effects and one not adequately relieved by laxatives.
In addition to the U.S., AstraZeneca has also submitted regulatory filings for MOVANTIK with health agencies in the European Union and Canada .
On June 4, 2014 , the New England Journal of Medicine published data online from two pivotal Phase III studies of MOVANTIK, KODIAC-4 and KODIAC-5. Both studies met their primary endpoint, showing an improvement in treatment effect versus placebo. Results from these studies show that more OIC non-cancer pain patients treated with MOVANTIK at a 25 mg dose had a consistent response of increased spontaneous bowel movements through 12 weeks of treatment compared to placebo.
About MOVANTIK TM (naloxegol oxalate)
MOVANTIK is an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA) specifically designed for the treatment of opioid-induced constipation (OIC) in patients with chronic non-cancer pain. In the Phase III clinical studies, MOVANTIK was administered as a once-daily tablet and is designed to block the binding of opioids to the opioid receptors in the gastrointestinal (GI) tract without impacting the opioid receptors in the brain.
About Opioid-Induced Constipation (OIC)
Opioids play an important role in chronic pain relief by binding mu-receptors in the brain. But they also bind mu-receptors in the bowel. That is why patients taking opioids for chronic pain can develop opioid-induced constipation (OIC). In fact, the incidence of OIC varies and has been reported as high as 81% in patients taking opioids.
Nektar Therapeutics has a robust R&D pipeline of potentially high-value therapeutics in pain, oncology and other therapeutic areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for MOVANTIK, an investigational drug candidate, which has been filed for regulatory approvals in the U.S., Europe and Canada as a once-daily, oral tablet for the treatment of opioid-induced constipation. This agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of MOVANTIK and an opioid. NKTR-181, a novel mu-opioid analgesic molecule for chronic pain conditions, has completed Phase 2 development in osteoarthritis patients with chronic knee pain. NKTR-171, a new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain, is in Phase 1 clinical development. In oncology, etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3 clinical study (the BEACON study) for the treatment of metastatic breast cancer and is also in Phase 2 studies for the treatment of ovarian, colorectal, lung and brain cancers. In anti-infectives, Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare as an adjunctive treatment for intubated and mechanically ventilated patients with Gram-negative pneumonia. Additional late-stage development candidates that leverage Nektar's proprietary technology platform include Baxter's BAX 855, a longer-acting PEGylated rFVIII therapeutic, which is in Phase 3 clinical development for patients with hemophilia A.
Nektar's technology has enabled eight approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.
Nektar is headquartered in San Francisco, California , with additional operations in Huntsville, Alabama and Hyderabad, India . Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com .
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Contact: Nektar Therapeutics Jennifer Ruddock 650-283-6253
SOURCE Nektar Therapeutics