Breaking News
March 23, 2019 - Evoke Pharma Submits Response to FDA Review Letter for Gimoti NDA
March 23, 2019 - Tracking HIV’s ever-evolving genome in effort to prioritize public health resources
March 23, 2019 - Scientists grow most sophisticated brain organoid to date
March 23, 2019 - ADHD drug raising risk of psychosis
March 22, 2019 - FDA approves brexanolone, first drug developed to treat postpartum depression
March 22, 2019 - Gruesome cat and dog experiments by the USDA exposed
March 22, 2019 - Ball pits used in children’s physical therapy may contribute to germ transmission
March 22, 2019 - Long-term use of inexpensive weight-loss drug may be safe and effective
March 22, 2019 - FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
March 22, 2019 - Anti-Müllerian Hormone Test: MedlinePlus Lab Test Information
March 22, 2019 - Finding the right exercise, diet aids for HIV patients
March 22, 2019 - Health Plans For State Employees Use Medicare’s Hammer On Hospital Bills
March 22, 2019 - Researchers develop new tool for imaging large groups of neurons in living animals
March 22, 2019 - Certain bacteria and immune factors in vagina may cause or protect against preterm birth
March 22, 2019 - Novel breath test could pave new way to non-invasively measure gut health
March 22, 2019 - Pharmaceutical and personal care products may result in new contaminants in waterways
March 22, 2019 - ACC: Catheter Ablation Does Not Cut Mortality, Stroke in A-Fib
March 22, 2019 - Wiedemann-Rautenstrauch syndrome – Genetics Home Reference
March 22, 2019 - Health insurance is not assurance of healthcare
March 22, 2019 - Supporting “curiosity-driven research” at the Discovery Innovation Awards
March 22, 2019 - Must-Reads Of The Week (Some Flying Below The Radar)
March 22, 2019 - Newly engineered nanoscale protein micelles can be tracked by MRI
March 22, 2019 - Pitt engineers win $550,000 NSF CAREER award to develop new intervention for people with ASD
March 22, 2019 - Early discharge does not increase readmission risk for patients after lung surgery
March 22, 2019 - Creating diverse pool of trained scientists to address Alzheimer’s research needs
March 22, 2019 - Surprising discovery offers clues to limit graft-vs.-host disease
March 22, 2019 - Study shows ACA’s positive impact on healthcare affordability and access for women
March 22, 2019 - Study provides new pathway for controlling inflammation
March 22, 2019 - New combination treatment shows promise for common brain tumor in children
March 22, 2019 - Virginia Tech Helmet Lab releases first youth-specific football helmet ratings
March 22, 2019 - New algae-based treatment could reduce need for limb amputation
March 22, 2019 - Stroke risk reduces in both black and white older Medicare beneficiaries, study reports
March 22, 2019 - City of Hope exhibits current studies and data on cancer therapies at AACR
March 22, 2019 - New study identifies CD40 molecule as key entry point for dangerous bacteria
March 22, 2019 - Health Tip: Six Steps to a Healthier Life
March 22, 2019 - even a little activity helps you live longer
March 22, 2019 - Many individuals recovering from addiction continue to suffer from chronic physical disease
March 22, 2019 - New drugs on PBS for Parkinson’s, MND and Cutaneous T cell lymphoma
March 22, 2019 - Saving energy also saves lives, UW-Madison study says
March 22, 2019 - Former inmates who receive social support have better mental health, study finds
March 22, 2019 - Nanofibrous membrane could enhance periodontal tissue regeneration
March 22, 2019 - Anti-vaxxer Italian leader down with chickenpox
March 22, 2019 - Servier collaborates with Harvard researchers to fight metabolic diseases
March 22, 2019 - National Eating Disorders Association
March 22, 2019 - Pumping up red blood cell production
March 22, 2019 - Excessive phosphate fertilizer may hurt plants by altering microbial composition in soil
March 22, 2019 - Medical marijuana laws could be improving older Americans’ health, study suggests
March 22, 2019 - Study indicates the benefits of stopping aspirin in heart attack patients
March 22, 2019 - Deep brain stimulation offers significant relief for patients with treatment-resistant depression
March 22, 2019 - Mental health problems in young adults on the rise
March 22, 2019 - Innovative membrane offers a viable solution for periodontitis
March 22, 2019 - The FDA Grants Rare Pediatric Disease Designation to Odiparcil for the Treatment of MPS VI
March 22, 2019 - insulin therapy: MedlinePlus Medical Encyclopedia
March 22, 2019 - Guidelines on the use of genetic testing in psychiatry
March 22, 2019 - Aspiring Doctors Seek Advanced Training In Addiction Medicine
March 22, 2019 - A change in focus could enable the development of new treatments for Alzheimer’s disease
March 22, 2019 - A new way to visualize the immune cell “landscape” of bowel cancer tumors
March 22, 2019 - Understanding maintenance of quiescent stem cells in chronic myelogenous leukemia
March 22, 2019 - Ludwig scientists to share advances in cancer research at AACR Annual Meeting 2019
March 22, 2019 - Less invasive valve replacement can be safe and effective alternative for healthier patients
March 22, 2019 - Aphasia research reveals new, complex interactions between thought and language
March 22, 2019 - Artificial neural networks can predict how different areas in the brain respond to words
March 22, 2019 - Age-related changes to gut microbiome have adverse impact on vascular health, study shows
March 22, 2019 - Study provides new insight into blood cell and immune cell production
March 22, 2019 - Isolated seniors chat online to prevent cognitive decline
March 22, 2019 - Repurposing drugs to outsmart cancers
March 22, 2019 - Naltrexone implant more effective in reducing relapses in HIV patients with opioid addiction
March 22, 2019 - The Brain Institute wins $7.04 million grant to investigate ‘neurophilosphy of free will’
March 22, 2019 - Karyopharm Announces FDA Extension of Review Period for Selinexor New Drug Application
March 22, 2019 - Eruptive xanthomatosis
March 22, 2019 - Cause of vascular disease in kidney failure reversed in animal model
March 22, 2019 - Researchers discover possible new therapeutic strategy for pancreatic cancer
March 22, 2019 - Ebola spreads to second largest city in DRC
March 22, 2019 - Perivascular spaces contribute to worse cognitive health in older adults
March 22, 2019 - Adolescent daily users more likely to obtain electronic cigarettes from commercial sources
March 22, 2019 - FDA Approves Genentech’s Tecentriq in Combination With Chemotherapy for the Initial Treatment of Adults With Extensive-Stage Small Cell Lung Cancer
March 22, 2019 - Diabetes myths and facts: MedlinePlus Medical Encyclopedia
March 22, 2019 - TGen and ABL pursue global rollout of advanced TB test
March 22, 2019 - Traffic light labels influence people to choose healthier and more sustainable meals
March 22, 2019 - Alzheimer’s patients using antiepileptic drugs have twice the risk of pneumonia, study shows
Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA

image_pdfDownload PDFimage_print

Treatment for Pain

Nektar Therapeutics Announces New Drug Application for NKTR-181 Accepted for Review by FDA

SAN FRANCISCO, July 30, 2018 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) today announced that the U.S. Food and Drug Administration (FDA) has filed and accepted for review the company’s New Drug Application (NDA) for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. NKTR-181 is a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a low incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics. The NDA is expected to be assigned a PDUFA (Prescription Drug User Fee Act) target action date of May 28, 2019 by the FDA.

Nektar’s NDA submission is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the NDA comprised 15 studies in 2,234 subjects and includes a 600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with noncancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/ pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.

NKTR-181 is an investigational medicine and has not been approved by the FDA or any other regulatory agencies. While the NDA submission for NKTR-181 has been accepted for review by the FDA, such acceptance does not mean that NKTR-181 will be approved by the FDA.

About Chronic Low Back Pain

Low back pain is the second most common cause of disability for adults in the U.S.1 Approximately 149 million work days are lost every year because of low back pain, with total costs estimated to be $100 to 200 billion a year (of which two-thirds is due to lost wages and lower productivity).2

About NKTR-181

NKTR-181 is the first long-acting, selective full mu-opioid receptor agonist designed to provide potent pain relief, without the inherent high levels of euphoria, which contribute to abuse and addiction with opioids. The novel molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier in order to slow its rate of entry into the brain and attenuate the dopamine release that underlies euphoria. In addition, NKTR-181 has a 14-hour elimination half-life to enable twice-daily dosing for pain control.

Current and past strategies of abuse deterrence to address the abuse potential properties of standard opioids rely on formulations alone. However, all abuse-deterrent formulations are pre-cursors to highly euphorigenic rapid-acting opioids, which can be liberated through tampering.

NKTR-181 is not a prodrug, a reformulation, or a drug product formulated for sustained release of an existing opioid. Nonclinical and clinical data show that the inherent properties of NKTR-181 reduce its rate of entry into the brain compared to standard mu opioids, regardless of route of administration.3

About Nektar Therapeutics

Nektar Therapeutics is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. 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.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements which can be identified by words such as: “design,” “leads to,” “address,” “can,” “will,” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the potential therapeutic benefit of NKTR-181 for treating patients with low back pain, the potential importance of NKTR-181 in addressing opioid abuse, the risks of opioid abuse resulting from use of NKTR-181, and certain other statements regarding the prospects and potential of NKTR-181. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) challenges and uncertainties inherent in the regulatory review of new drugs, where the risk of failure remains high due to negative determinations by the FDA or other regulatory agencies regarding efficacy, safety or other requirements, which determinations which are outside the control of Nektar; (ii) the regulatory pathway to review and approve NKTR-181 for use in patients, even with a Fast Track designation by the FDA, is subject to substantial uncertainty both in the United States and in equivalent foreign regulatory agencies; (iii) regulations concerning and controlling the access to opioid-based pharmaceuticals are strict and there is no guarantee which scheduling category will apply to NKTR-181 if regulatory approval is achieved; (iv) drug manufacturing challenges which can delay or render unavailable sufficient supplies of NKTR-181; (v) changing standards of care and new regulations (including, but not limited to, standards and regulations related to health care cost containment) can affect the use NKTR-181 and commercial success following a regulatory approval; (vi) Nektar’s patent applications for NKTR-181 may not issue in one or more jurisdictions, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required in the future; (vii) the outcome of any existing or future intellectual property or other litigation related to Nektar’s proprietary product candidates, including, without limitation, NKTR-181, is unpredictable and could have a material adverse effect on our business; and (viii) certain other important risks and uncertainties set forth in Nektar’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

1. Arch Intern Med 2009 February 9; 169(3): 251-258.

2. World Health Organization: Priority Medicines for Europe and the World Update Report, 2013; Background Paper 6.24, Low Back Pain.

3. 2010 Society of Neuroscience Annual Meeting (Nov 13-17, #HHH11)

SOURCE Nektar Therapeutics

Posted: July 2018

Related Articles

NKTR-181 (loxicodegol) FDA Approval History

Tagged with:

About author

Related Articles